Trial Outcomes & Findings for Appetite Suppression Trial With Polydextrose (NCT NCT02064205)
NCT ID: NCT02064205
Last Updated: 2022-06-06
Results Overview
Yogurt with a polydextrose (fiber with satiating effect) is consumed in the morning with breakfast or later in the morning. The satiating effect of the addition of polydextrose is tested on the amount of food consumed with lunch four hours or 1.5h later.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Four hours or 1.5 hour after consumption of a pre-load at up to day 22
Results posted on
2022-06-06
Participant Flow
Recruitment lasted from May 2014 - August 2014. 121 subjects were planned for screening. 46 subjects met the inclusion criteria, 37 subjects did not show up, and 38 subjects had screening failures. The CRO that conducted the clinical trial was: QPS Netherlands B.V. Groningen The Netherlands
In the study four test days were conducted, one weekly. Between test day there are six days of wash-out.
Participant milestones
| Measure |
All Study Participants
A: Breakfast with the pre-load and 12.5 g polydextrose B:Breakfast with the pre-load without polydextrose C: Breakfast and pre-load with 12.5 g polydextrose at 150 min D:Breakfast and pre-load without polydextrose at t=150 min
Eight orders:
A-B-D-C; B-C-A-D; C-D-B-A; D-A-C-B; A-D-B-C; C-B-D-A; B-A-C-D; D-C-A-B.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
Condition A
|
32
|
|
Overall Study
Condition B
|
32
|
|
Overall Study
Condition C
|
31
|
|
Overall Study
Condition D
|
32
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Study Participants
A: Breakfast with the pre-load and 12.5 g polydextrose B:Breakfast with the pre-load without polydextrose C: Breakfast and pre-load with 12.5 g polydextrose at 150 min D:Breakfast and pre-load without polydextrose at t=150 min
Eight orders:
A-B-D-C; B-C-A-D; C-D-B-A; D-A-C-B; A-D-B-C; C-B-D-A; B-A-C-D; D-C-A-B.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Appetite Suppression Trial With Polydextrose
Baseline characteristics by cohort
| Measure |
Overall Baseline Charactistics of 32 Slightly Overweight Women
n=32 Participants
Baseline data of the subjects were measured at screening at least one week before the start of the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Age, Continuous
|
27.4 years
STANDARD_DEVIATION 6.6 • n=39 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
Netherlands
|
32 participants
n=39 Participants
|
|
Body weight
|
74.4 kg
STANDARD_DEVIATION 7.8 • n=39 Participants
|
|
Height
|
1.70 meter
STANDARD_DEVIATION 0.04 • n=39 Participants
|
|
BMI
|
25.9 kg/m^2
STANDARD_DEVIATION 2.7 • n=39 Participants
|
|
BPsys
|
113.5 mm Hg
STANDARD_DEVIATION 9.9 • n=39 Participants
|
|
BPdia
|
64.2 mm Hg
STANDARD_DEVIATION 9.0 • n=39 Participants
|
|
Dutch Eating Restraintness Score
|
2.4 units on a scale
STANDARD_DEVIATION 0.4 • n=39 Participants
|
|
Dietary fiber intake
|
18 grams/day
STANDARD_DEVIATION 4 • n=39 Participants
|
PRIMARY outcome
Timeframe: Four hours or 1.5 hour after consumption of a pre-load at up to day 22Population: Energy intake
Yogurt with a polydextrose (fiber with satiating effect) is consumed in the morning with breakfast or later in the morning. The satiating effect of the addition of polydextrose is tested on the amount of food consumed with lunch four hours or 1.5h later.
Outcome measures
| Measure |
Polydextrose Syrup at Breakfast [A]
n=31 Participants
Breakfast with pre-load four hours before lunch
12.5 g polydextrose: Appetite suppressing supplement is added in yogurt and provided with breakfast, four hours before lunch.
|
Glucose Syrup at Breakfast (Control) [B]
n=31 Participants
Breakfast with control pre-load four hours before lunch
Yogurt with control (glucose syrup) is tested for its satiating effect.
glucose syrup: Glucose syrup is used a control product for the polydextrose
|
Pre-load With Polydextroseglucose Before Lunch [C]
n=31 Participants
Breakfast without pre-load. Pre-load with yogurt and polydextrose provided 1.5h before lunch.
12.5 g polydextrose: Appetite suppressing supplement is added in yogurt 1.5h before lunch.
|
Pre-load With Yogurt and Glucose Before Lunch [D]
n=31 Participants
Breakfast without pre-load. Pre-load with yogurt and glucose (control) provided 1.5h before lunch.
Yogurt with control (glucose syrup) is tested for its satiating effect 1.5h before lunch
|
|---|---|---|---|---|
|
Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.
|
2694 kJ
Standard Deviation 1028
|
2537 kJ
Standard Deviation 933
|
2317 kJ
Standard Deviation 940
|
2335 kJ
Standard Deviation 1051
|
SECONDARY outcome
Timeframe: one dayThe appetite suppressive effect of polydextrose measured with Visual Analogue rating Scales (VAS). The AUCs were calculated for the scores obtained before - first score after meal intake (satiation) and for score after meal till start of next meal (in between meals, satiety). The VAS scores ranged from 0-100 for hunger and fullness (HUNGER: 0 = no hunger , 100 = very hungry; FULNESS: 0 = not full, 100 = very full)
Outcome measures
| Measure |
Polydextrose Syrup at Breakfast [A]
n=32 Participants
Breakfast with pre-load four hours before lunch
12.5 g polydextrose: Appetite suppressing supplement is added in yogurt and provided with breakfast, four hours before lunch.
|
Glucose Syrup at Breakfast (Control) [B]
n=32 Participants
Breakfast with control pre-load four hours before lunch
Yogurt with control (glucose syrup) is tested for its satiating effect.
glucose syrup: Glucose syrup is used a control product for the polydextrose
|
Pre-load With Polydextroseglucose Before Lunch [C]
n=31 Participants
Breakfast without pre-load. Pre-load with yogurt and polydextrose provided 1.5h before lunch.
12.5 g polydextrose: Appetite suppressing supplement is added in yogurt 1.5h before lunch.
|
Pre-load With Yogurt and Glucose Before Lunch [D]
n=31 Participants
Breakfast without pre-load. Pre-load with yogurt and glucose (control) provided 1.5h before lunch.
Yogurt with control (glucose syrup) is tested for its satiating effect 1.5h before lunch
|
|---|---|---|---|---|
|
The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)
Hunger score
|
358.3 mm*min
Standard Deviation 183.4
|
336.8 mm*min
Standard Deviation 158.9
|
356.7 mm*min
Standard Deviation 169.1
|
280.2 mm*min
Standard Deviation 167.2
|
|
The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)
Fullness score during first phase
|
-424.7 mm*min
Standard Deviation 192.4
|
-443.0 mm*min
Standard Deviation 190.7
|
-326.6 mm*min
Standard Deviation 207.6
|
-308.2 mm*min
Standard Deviation 155.6
|
|
The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)
Hunger score (satiety period)
|
4898.9 mm*min
Standard Deviation 3424
|
4134.9 mm*min
Standard Deviation 2962.9
|
962.8 mm*min
Standard Deviation 1232.2
|
592.9 mm*min
Standard Deviation 987.2
|
|
The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)
Fulness score (satiety period)
|
-6009.9 mm*min
Standard Deviation 3670.8
|
-5048.3 mm*min
Standard Deviation 4088.4
|
-734.8 mm*min
Standard Deviation 1263.5
|
-1077.4 mm*min
Standard Deviation 1118.1
|
SECONDARY outcome
Timeframe: Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22.Population: Only in condition A and B blood was drawn and satiety hormones were analyzed.
The satiety hormones CCK, GLP-1, ghrelin and PYY are measured before (t=0) and after breakfast consumption (at t=30, 60, 90, 150, 240) . This is done on day 01, day 08, day 15 and day 22 with at least four days wash-out in-between. The satiety hormones were only measured in the conditions when the pre-load was given with breakfast (condition A and B). Area under the curves were calculated of the time curves.
Outcome measures
| Measure |
Polydextrose Syrup at Breakfast [A]
n=32 Participants
Breakfast with pre-load four hours before lunch
12.5 g polydextrose: Appetite suppressing supplement is added in yogurt and provided with breakfast, four hours before lunch.
|
Glucose Syrup at Breakfast (Control) [B]
n=32 Participants
Breakfast with control pre-load four hours before lunch
Yogurt with control (glucose syrup) is tested for its satiating effect.
glucose syrup: Glucose syrup is used a control product for the polydextrose
|
Pre-load With Polydextroseglucose Before Lunch [C]
Breakfast without pre-load. Pre-load with yogurt and polydextrose provided 1.5h before lunch.
12.5 g polydextrose: Appetite suppressing supplement is added in yogurt 1.5h before lunch.
|
Pre-load With Yogurt and Glucose Before Lunch [D]
Breakfast without pre-load. Pre-load with yogurt and glucose (control) provided 1.5h before lunch.
Yogurt with control (glucose syrup) is tested for its satiating effect 1.5h before lunch
|
|---|---|---|---|---|
|
Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.
CCK (AUC)
|
241.15 (mcg*min)/mL
Standard Deviation 113.69
|
265.03 (mcg*min)/mL
Standard Deviation 112.44
|
—
|
—
|
|
Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.
Ghrelin (AUC)
|
-23479 (mcg*min)/mL
Standard Deviation 33428
|
-20902 (mcg*min)/mL
Standard Deviation 21150
|
—
|
—
|
|
Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.
PYY (AUC)
|
1745.5 (mcg*min)/mL
Standard Deviation 2861.7
|
1210.5 (mcg*min)/mL
Standard Deviation 2832.6
|
—
|
—
|
|
Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.
GLP-1 (AUC)
|
447.65 (mcg*min)/mL
Standard Deviation 298.11
|
316.02 (mcg*min)/mL
Standard Deviation 244.98
|
—
|
—
|
Adverse Events
Condition A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Condition B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Condition C
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Condition D
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Condition A
n=32 participants at risk
Breakfast with preload of yogurt and polydextrose
|
Condition B
n=32 participants at risk
Breakfast with preload of yogurt and glucose control
|
Condition C
n=31 participants at risk
Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and polydextrose
|
Condition D
n=32 participants at risk
Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and glucose syrup
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
6.2%
2/32 • During the conduct of the study; June - November 2014
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
6.5%
2/31 • During the conduct of the study; June - November 2014
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
|
Gastrointestinal disorders
Nausea
|
6.2%
2/32 • During the conduct of the study; June - November 2014
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
3.2%
1/31 • During the conduct of the study; June - November 2014
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
6.2%
2/32 • During the conduct of the study; June - November 2014
|
0.00%
0/31 • During the conduct of the study; June - November 2014
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
|
Gastrointestinal disorders
Abdominal distension
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
0.00%
0/31 • During the conduct of the study; June - November 2014
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
0.00%
0/31 • During the conduct of the study; June - November 2014
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
3.2%
1/31 • During the conduct of the study; June - November 2014
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
|
Nervous system disorders
Presyncope (light headedness)
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
0.00%
0/31 • During the conduct of the study; June - November 2014
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
0.00%
0/31 • During the conduct of the study; June - November 2014
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
|
General disorders
catheter site pain
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
0.00%
0/31 • During the conduct of the study; June - November 2014
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
|
General disorders
Pyrexia (fever)
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
0.00%
0/31 • During the conduct of the study; June - November 2014
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
|
Infections and infestations
Infections and infestations
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
3.2%
1/31 • During the conduct of the study; June - November 2014
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
0.00%
0/31 • During the conduct of the study; June - November 2014
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
3.1%
1/32 • During the conduct of the study; June - November 2014
|
0.00%
0/31 • During the conduct of the study; June - November 2014
|
0.00%
0/32 • During the conduct of the study; June - November 2014
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place