Trial Outcomes & Findings for Healthy Aging Through Functional Food (NCT NCT02095873)
NCT ID: NCT02095873
Last Updated: 2017-03-06
Results Overview
A standard 75 g glucose oGTT will be performed, as routinely used in clinical practice. Participants will be instructed to eat carbohydrate rich diet (\> 150 g/day) for at least three days before the test, followed by an overnight fast. Participants will be instructed to have comparable macronutrient composition of the dinner before the respective study days in the metabolic unit. During the oGTT both capillary and venous blood samples will be collected after 0, 15, 30, 60, 90 and 120 min. To minimize the inconvenience of repeated blood tests during the oGTT, a venous cannula will be inserted, under sterile conditions, prior to the test, for blood sampling.
COMPLETED
PHASE1/PHASE2
32 participants
Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
2017-03-06
Participant Flow
Participant milestones
| Measure |
Glyoxalase 1 Inducer First, Then Placebo
Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol \& 120 mg hesperetin combination) once daily, 8 weeks; then Placebo (excipient: Mannitol, 108 mg) once daily, 8 weeks.
|
Placebo Then Glyoxalase 1 Inducer
Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks; then Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol \& 120 mg hesperetin combination) once daily, 8 weeks.
|
|---|---|---|
|
First Intervention (8 Weeks)
STARTED
|
16
|
16
|
|
First Intervention (8 Weeks)
COMPLETED
|
15
|
16
|
|
First Intervention (8 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Second Intervention (8 Weeks)
STARTED
|
15
|
16
|
|
Second Intervention (8 Weeks)
COMPLETED
|
13
|
16
|
|
Second Intervention (8 Weeks)
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Glyoxalase 1 Inducer First, Then Placebo
Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol \& 120 mg hesperetin combination) once daily, 8 weeks; then Placebo (excipient: Mannitol, 108 mg) once daily, 8 weeks.
|
Placebo Then Glyoxalase 1 Inducer
Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks; then Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol \& 120 mg hesperetin combination) once daily, 8 weeks.
|
|---|---|---|
|
First Intervention (8 Weeks)
Withdrawal by Subject
|
1
|
0
|
|
Second Intervention (8 Weeks)
Withdrawal by Subject
|
1
|
0
|
|
Second Intervention (8 Weeks)
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Healthy Aging Through Functional Food
Baseline characteristics by cohort
| Measure |
Glyoxalase 1 Inducer Then Placebo
n=15 Participants
Glyoxalase 1 inducer (90 mg trans-resveratrol \& 120 mg hesperetin), once daily, 8 weeks; then Placebo (excipient: 108 mg mannitol), once daily, 8 weeks.
|
Placebo Then Glyoxalase 1 Inducer
n=17 Participants
Placebo (excipient: 108 mg mannitol), once daily, 8 weeks; then Glyoxalase 1 inducer (90 mg trans-resveratrol \& 120 mg hesperetin), once daily, 8 weeks.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 12 • n=99 Participants
|
44 years
STANDARD_DEVIATION 13 • n=107 Participants
|
45 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Gender
Female
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Gender
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
15 participants
n=99 Participants
|
17 participants
n=107 Participants
|
32 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)Population: Highly overweight/obese (BMI\>27.5 kg/m2) subgroup, based on subject BMI at study entry.
A standard 75 g glucose oGTT will be performed, as routinely used in clinical practice. Participants will be instructed to eat carbohydrate rich diet (\> 150 g/day) for at least three days before the test, followed by an overnight fast. Participants will be instructed to have comparable macronutrient composition of the dinner before the respective study days in the metabolic unit. During the oGTT both capillary and venous blood samples will be collected after 0, 15, 30, 60, 90 and 120 min. To minimize the inconvenience of repeated blood tests during the oGTT, a venous cannula will be inserted, under sterile conditions, prior to the test, for blood sampling.
Outcome measures
| Measure |
Glyoxalase 1 Inducer
n=20 Participants
Glyoxalase 1 inducer (90 mg trans-resveratrol \& 120 mg hesperetin), once daily, 8 weeks.
|
Placebo
n=20 Participants
Placebo (excipient: 108 mg mannitol), capsule, once daily, 8 weeks.
|
|---|---|---|
|
Area Under the Curve for Oral Glucose Tolerance Test (oGGT)
Post-8 weeks treatment
|
9.9 mM h
Standard Error 0.6
|
10.6 mM h
Standard Error 0.6
|
|
Area Under the Curve for Oral Glucose Tolerance Test (oGGT)
Baseline
|
10.8 mM h
Standard Error 0.7
|
11.0 mM h
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)Population: All subjects with where baseline and post-8 treatment data were obtained.
After 20 min seated at rest, measurements are made with the subject seated and the left hand at heart level. Nail-fold capillaries in the dorsal skin of the third finger are visualized using a stereo microscope linked to a monochrome digital camera. Capillary density is defined as the number of capillaries per mm2 of nail-fold skin and is computed as the mean of 4 measurements.
Outcome measures
| Measure |
Glyoxalase 1 Inducer
n=28 Participants
Glyoxalase 1 inducer (90 mg trans-resveratrol \& 120 mg hesperetin), once daily, 8 weeks.
|
Placebo
n=24 Participants
Placebo (excipient: 108 mg mannitol), capsule, once daily, 8 weeks.
|
|---|---|---|
|
Finger-fold Capillary Density by Capillaroscopy
Baseline
|
115 number of capillaries per mm2
Interval 90.0 to 140.0
|
119 number of capillaries per mm2
Interval 107.0 to 164.0
|
|
Finger-fold Capillary Density by Capillaroscopy
Post-8 weeks treatment
|
125 number of capillaries per mm2
Interval 88.0 to 169.0
|
128 number of capillaries per mm2
Interval 104.0 to 149.0
|
SECONDARY outcome
Timeframe: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)Population: All subjects completing the study per protocol
Brachial artery FMD will be assessed. Ultrasound imaging of the brachial artery will be performed. Percent FMD will be calculated using the averaged minimum mean brachial artery diameter at baseline compared to the largest mean values obtained after either release of the forearm occlusion.
Outcome measures
| Measure |
Glyoxalase 1 Inducer
n=29 Participants
Glyoxalase 1 inducer (90 mg trans-resveratrol \& 120 mg hesperetin), once daily, 8 weeks.
|
Placebo
n=29 Participants
Placebo (excipient: 108 mg mannitol), capsule, once daily, 8 weeks.
|
|---|---|---|
|
Flow-mediated Dilatation (FMD)
Post-8 weeks treatment
|
0.12 percentage of baseline value
Interval 0.06 to 0.31
|
0.26 percentage of baseline value
Interval 0.07 to 0.47
|
|
Flow-mediated Dilatation (FMD)
Baseline
|
0.17 percentage of baseline value
Interval 0.1 to 0.35
|
0.18 percentage of baseline value
Interval 0.07 to 0.49
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)Population: Subjects for which PWV data were obtained at baseline and post 8-weeks treatment.
Aortal pulse wave velocity is measured by a non-invasive oscillometric device.
Outcome measures
| Measure |
Glyoxalase 1 Inducer
n=13 Participants
Glyoxalase 1 inducer (90 mg trans-resveratrol \& 120 mg hesperetin), once daily, 8 weeks.
|
Placebo
n=12 Participants
Placebo (excipient: 108 mg mannitol), capsule, once daily, 8 weeks.
|
|---|---|---|
|
Aortal Pulse Wave Velocity (aPWV)
Baseline
|
7.9 m/s
Interval 7.1 to 8.8
|
8.3 m/s
Interval 7.4 to 9.2
|
|
Aortal Pulse Wave Velocity (aPWV)
Post-8 weeks treatment
|
8.0 m/s
Interval 7.1 to 10.0
|
8.5 m/s
Interval 7.5 to 9.0
|
Adverse Events
Glo1-inducer Then Placebo
Placebo Then Glo1-inducer
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