Trial Outcomes & Findings for Cardio-vascular Protective Effects of Wolfberry in Middle-aged and Older Adults (NCT NCT03535844)
NCT ID: NCT03535844
Last Updated: 2020-04-22
Results Overview
The main classes of lipids in the cell membrane
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Pre- and post-intervention (Week 16)
Results posted on
2020-04-22
Participant Flow
Participant milestones
| Measure |
Wolfberry With Healthy Diet
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
19
|
|
Overall Study
COMPLETED
|
22
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Wolfberry With Healthy Diet
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Cardio-vascular Protective Effects of Wolfberry in Middle-aged and Older Adults
Baseline characteristics by cohort
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 4 • n=99 Participants
|
56 years
STANDARD_DEVIATION 4 • n=107 Participants
|
56 years
STANDARD_DEVIATION 4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Singapore
|
22 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Use of prescription medication and/or supplements
|
22 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre- and post-intervention (Week 16)The main classes of lipids in the cell membrane
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Pre- and post-intervention (Week 16)Carotid intima media thickness measured using high-frequency ultrasonographic imaging
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Change in Carotid Intima Media Thickness
Week 0
|
0.67 mm
Standard Deviation 0.11
|
0.60 mm
Standard Deviation 0.10
|
|
Change in Carotid Intima Media Thickness
Week16
|
0.67 mm
Standard Deviation 0.12
|
0.70 mm
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: Pre- and post-intervention (Week 16)Quantity and quality of circulating endothelial progenitor cells
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Change in Endothelial Progenitor Cells
Week 0
|
9.89 cells
Standard Deviation 3.43
|
10.36 cells
Standard Deviation 2.67
|
|
Change in Endothelial Progenitor Cells
Week 16
|
9.64 cells
Standard Deviation 2.29
|
9.46 cells
Standard Deviation 2.87
|
PRIMARY outcome
Timeframe: Pre- and post-intervention (Week 16)Brachial artery flow mediated dilation measured using high-frequency ultrasonographic imaging
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Change in Flow Mediated Dilation
Week 0
|
4.50 % dilation
Standard Deviation 3.24
|
3.95 % dilation
Standard Deviation 3.12
|
|
Change in Flow Mediated Dilation
Week 16
|
3.79 % dilation
Standard Deviation 2.68
|
5.34 % dilation
Standard Deviation 2.49
|
PRIMARY outcome
Timeframe: Pre- and post-intervention (Week 16)Concentrations of plasma total nitrate/nitrite using commercially available ELISA assay kits.
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Change in Plasma Nitric Oxide
Nitric oxide Week 0
|
15.91 nmol/mL
Standard Deviation 8.39
|
14.53 nmol/mL
Standard Deviation 6.8
|
|
Change in Plasma Nitric Oxide
Nitric oxide Week 16
|
19.38 nmol/mL
Standard Deviation 10.12
|
19.55 nmol/mL
Standard Deviation 8.27
|
PRIMARY outcome
Timeframe: Pre- and post-intervention (Week 16)Fasting state plasma carotenoids using high performance liquid chromatography.
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Change in Blood Carotenoid Status
Week 0
|
2020.9 nmol/L
Standard Deviation 192.3
|
2746.3 nmol/L
Standard Deviation 224
|
|
Change in Blood Carotenoid Status
Week 16
|
1916.2 nmol/L
Standard Deviation 218.7
|
1682.9 nmol/L
Standard Deviation 209.7
|
PRIMARY outcome
Timeframe: Pre- and post-intervention (Week 16)Concentrations of plasma endothelin-1 using commercially available ELISA assay kits.
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Change in Plasma Endothelin-1
Endothelin1 Week 0
|
1.31 pg/mL
Standard Deviation 0.56
|
1.19 pg/mL
Standard Deviation 0.6
|
|
Change in Plasma Endothelin-1
Endothelin1 Week 16
|
1.11 pg/mL
Standard Deviation 0.48
|
1.04 pg/mL
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: Pre- and post-intervention (Week 16)Concentrations of plasma intercellular adhesion molecule-1 using commercially available ELISA assay kits.
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Change in Plasma ICAM-1
ICAM-1 Week 16
|
7.43 ng/mL
Standard Deviation 2.43
|
7.14 ng/mL
Standard Deviation 2.25
|
|
Change in Plasma ICAM-1
ICAM-1 Week 0
|
7.4 ng/mL
Standard Deviation 2.33
|
7.1 ng/mL
Standard Deviation 2.52
|
SECONDARY outcome
Timeframe: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reportedTotal cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and total triglyceride
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Change in Blood Lipid-lipoprotein Concentrations
TG Week 0
|
1.18 mmol/L
Standard Deviation 0.54
|
1.32 mmol/L
Standard Deviation 0.62
|
|
Change in Blood Lipid-lipoprotein Concentrations
TG Week 16
|
1.15 mmol/L
Standard Deviation 0.52
|
1.36 mmol/L
Standard Deviation 0.73
|
|
Change in Blood Lipid-lipoprotein Concentrations
TC Week 0
|
5.16 mmol/L
Standard Deviation 0.87
|
5.36 mmol/L
Standard Deviation 1.17
|
|
Change in Blood Lipid-lipoprotein Concentrations
TC Week 16
|
5.30 mmol/L
Standard Deviation 0.88
|
5.31 mmol/L
Standard Deviation 1.16
|
|
Change in Blood Lipid-lipoprotein Concentrations
LDL Week 0
|
3.06 mmol/L
Standard Deviation 0.63
|
3.23 mmol/L
Standard Deviation 1.10
|
|
Change in Blood Lipid-lipoprotein Concentrations
LDL Week 16
|
3.14 mmol/L
Standard Deviation 0.6
|
3.16 mmol/L
Standard Deviation 1.11
|
|
Change in Blood Lipid-lipoprotein Concentrations
HDL Week 0
|
1.56 mmol/L
Standard Deviation 0.49
|
1.54 mmol/L
Standard Deviation 0.42
|
|
Change in Blood Lipid-lipoprotein Concentrations
HDL Week 16
|
1.65 mmol/L
Standard Deviation 0.47
|
1.53 mmol/L
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reportedBoth systolic and diastolic blood pressure
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Change in Blood Pressure
Systolic Week 0
|
114 mmHg
Standard Deviation 18
|
106 mmHg
Standard Deviation 13
|
|
Change in Blood Pressure
Systolic Week 16
|
111 mmHg
Standard Deviation 15
|
107 mmHg
Standard Deviation 13
|
|
Change in Blood Pressure
Diastolic Week 0
|
72 mmHg
Standard Deviation 12
|
69 mmHg
Standard Deviation 9
|
|
Change in Blood Pressure
Diastolic Week 16
|
73 mmHg
Standard Deviation 10
|
69 mmHg
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Pre- and post-intervention (Week 16)Concentrations of plasma biomarkers of oxidative stress.
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Change in Oxidative Stress-related Biomarkers
MDA Week 0
|
0.294 uM
Standard Deviation 0.021
|
0.327 uM
Standard Deviation 0.037
|
|
Change in Oxidative Stress-related Biomarkers
MDA Week 16
|
0.282 uM
Standard Deviation 0.021
|
0.316 uM
Standard Deviation 0.025
|
SECONDARY outcome
Timeframe: Pre- and post-intervention (Week 16)Dual-energy X-ray absorptiometry
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Change in Body Composition
% Body Fat Week 0
|
36.5 % Body Fat
Standard Deviation 6.9
|
35.1 % Body Fat
Standard Deviation 6.1
|
|
Change in Body Composition
% Body Fat Week 16
|
36.2 % Body Fat
Standard Deviation 7.4
|
34.4 % Body Fat
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reportedMeasured using resonance Raman spectroscopy to obtain a skin carotenoid status, a score which ranges from 10000 to 89000. Higher score represents higher concentration of carotenoids in skin, hence, an improved outcome
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Change in Skin Carotenoid Status
Week 16
|
37879 score on a scale
Standard Deviation 2841
|
35426 score on a scale
Standard Deviation 2065
|
|
Change in Skin Carotenoid Status
Week 0
|
33636 score on a scale
Standard Deviation 2724
|
33713 score on a scale
Standard Deviation 1954
|
SECONDARY outcome
Timeframe: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported(body mass) divided by (height x height)
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Body Mass Index
Week 0
|
22.7 kg/m^2
Standard Deviation 3.7
|
22.8 kg/m^2
Standard Deviation 2.5
|
|
Body Mass Index
Week 16
|
22.7 kg/m^2
Standard Deviation 3.7
|
22.9 kg/m^2
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reportedMeasurement of waist circumference using World Health Organization guidelines
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Change in Waist Circumference
Week 0
|
80.5 cm
Standard Deviation 9.6
|
22.9 cm
Standard Deviation 2.3
|
|
Change in Waist Circumference
Week 16
|
80.4 cm
Standard Deviation 9.6
|
22.8 cm
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reportedA subjective visual analogue scale consisting of a 100 mm line for each term (1) hunger; (2) fullness; (3) desire to eat; (4) prospective food consumption. Subjects respond by placing a mark on the line that is anchored with an extreme answer at either end (e.g. "not felt at all" and "felt the greatest") A composite appetite score is computed by: (hunger + desire to eat + (100 - fullness) + prospective food consumption) divided by 4. With a maximum score of 400 for the greatest possible appetite (represented by hunger = 100; desire to eat = 100; fullness = 0 and prospective food consumption = 100) and a minimum score of 0 (represented by hunger = 0; desire to eat = 0; fullness = 100 and prospective food consumption = 0)
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Change in Appetite
Week 0
|
215 score on a scale
Standard Deviation 17
|
209 score on a scale
Standard Deviation 64
|
|
Change in Appetite
Week 16
|
194 score on a scale
Standard Deviation 104
|
185 score on a scale
Standard Deviation 81
|
SECONDARY outcome
Timeframe: Pre- and post-intervention (Week 16)Analysis of dietary carotenoids using 3-day food records
Outcome measures
| Measure |
Wolfberry With Healthy Diet
n=22 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided specific instructions to cook and consume 15 g/day wolfberry as part of a mixed-meal.
Wolfberry: Consumption of cooked dehydrated wolfberry as part of a mixed meal.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
Healthy Diet
n=18 Participants
Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet.
Healthy diet: Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
|
|---|---|---|
|
Dietary Carotenoids
Week 0
|
8627.1 ug
Standard Deviation 1637.1
|
11087.4 ug
Standard Deviation 1708.3
|
|
Dietary Carotenoids
Week 16
|
10487.8 ug
Standard Deviation 1099.5
|
12845.98 ug
Standard Deviation 1791.12
|
SECONDARY outcome
Timeframe: Pre- and post-intervention (Week 16)Measured using The Pittsburgh Sleep Quality Index (PSQI) and sleep evaluation questionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre- and post-intervention (Week 16)Measured using Montreal cognitive assessment (MOCA)
Outcome measures
Outcome data not reported
Adverse Events
Wolfberry With Healthy Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place