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Healthy Aging Through Functional Food (HATFF)

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ClinicalTrials.gov Identifier: NCT02095873
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Collaborators:
Technology Strategy Board, United Kingdom
Unilever R&D
Information provided by (Responsible Party):
Professor Paul J. Thornalley, University of Warwick

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Glucose Intolerance
Aortic Stiffness
Vasodilation
Interventions Dietary Supplement: Glyoxalase 1 (Glo1) inducer
Dietary Supplement: Placebo
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glyoxalase 1 Inducer First, Then Placebo Placebo Then Glyoxalase 1 Inducer
Hide Arm/Group Description 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 (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.
Period Title: First Intervention (8 Weeks)
Started 16 16
Completed 15 16
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Period Title: Second Intervention (8 Weeks)
Started 15 16
Completed 13 16
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             1             0
Protocol Violation             1             0
Arm/Group Title Glyoxalase 1 Inducer Then Placebo Placebo Then Glyoxalase 1 Inducer Total
Hide Arm/Group Description 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 (excipient: 108 mg mannitol), once daily, 8 weeks; then Glyoxalase 1 inducer (90 mg trans-resveratrol & 120 mg hesperetin), once daily, 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 15 17 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 17 participants 32 participants
45  (12) 44  (13) 45  (13)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Female
10
  66.7%
12
  70.6%
22
  68.8%
Male
5
  33.3%
5
  29.4%
10
  31.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 15 participants 17 participants 32 participants
15 17 32
1.Primary Outcome
Title Area Under the Curve for Oral Glucose Tolerance Test (oGGT)
Hide Description 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.
Time Frame Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
Highly overweight/obese (BMI>27.5 kg/m2) subgroup, based on subject BMI at study entry.
Arm/Group Title Glyoxalase 1 Inducer Placebo
Hide Arm/Group Description:
Glyoxalase 1 inducer (90 mg trans-resveratrol & 120 mg hesperetin), once daily, 8 weeks.
Placebo (excipient: 108 mg mannitol), capsule, once daily, 8 weeks.
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: mM h
Baseline 10.8  (0.7) 11.0  (0.7)
Post-8 weeks treatment 9.9  (0.6) 10.6  (0.6)
2.Secondary Outcome
Title Finger-fold Capillary Density by Capillaroscopy
Hide Description 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.
Time Frame Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with where baseline and post-8 treatment data were obtained.
Arm/Group Title Glyoxalase 1 Inducer Placebo
Hide Arm/Group Description:
Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks.
Overall Number of Participants Analyzed 28 24
Median (Inter-Quartile Range)
Unit of Measure: number of capillaries per mm2
Baseline
115
(90 to 140)
119
(107 to 164)
Post-8 weeks treatment
125
(88 to 169)
128
(104 to 149)
3.Secondary Outcome
Title Flow-mediated Dilatation (FMD)
Hide Description 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.
Time Frame Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects completing the study per protocol
Arm/Group Title Glyoxalase 1 Inducer Placebo
Hide Arm/Group Description:
Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks.
Overall Number of Participants Analyzed 29 29
Median (Inter-Quartile Range)
Unit of Measure: percentage of baseline value
Baseline
0.17
(0.10 to 0.35)
0.18
(0.07 to 0.49)
Post-8 weeks treatment
0.12
(0.06 to 0.31)
0.26
(0.07 to 0.47)
4.Other Pre-specified Outcome
Title Aortal Pulse Wave Velocity (aPWV)
Hide Description Aortal pulse wave velocity is measured by a non-invasive oscillometric device.
Time Frame Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects for which PWV data were obtained at baseline and post 8-weeks treatment.
Arm/Group Title Glyoxalase 1 Inducer Placebo
Hide Arm/Group Description:
Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks.
Overall Number of Participants Analyzed 13 12
Median (Inter-Quartile Range)
Unit of Measure: m/s
Baseline
7.9
(7.1 to 8.8)
8.3
(7.4 to 9.2)
Post-8 weeks treatment
8.0
(7.1 to 10.0)
8.5
(7.5 to 9.0)
Time Frame From baseline to study completion: 8 weeks Glo1-inducer, 6 weeks washout then 8 weeks placebo; or 8 weeks placebo, 6 weeks washout then 8 weeks Glo1-inducer.
Adverse Event Reporting Description All potential clinical adverse effects were monitoring including nausea, loss of appetite, gastrointestinal side effects and other symptoms. Clinical chemistry and haematological assessments were also made.
 
Arm/Group Title Glo1-inducer Then Placebo Placebo Then Glo1-inducer
Hide Arm/Group Description Glyoxalase 1 inducer: capsule, 90 mg trans-resveratrol & 120 mg hesperetin, once daily for 8 weeks; then 6-weeks washout; then placebo capsule (mannitol, 210 mg), once daily for 8 weeks. Placebo capsule (mannitol, 210 mg), once daily for 8 weeks; then 6-weeks washout; then Glyoxalase 1 inducer: capsule, 90 mg trans-resveratrol & 120 mg hesperetin, once daily for 8 weeks.
All-Cause Mortality
Glo1-inducer Then Placebo Placebo Then Glo1-inducer
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Glo1-inducer Then Placebo Placebo Then Glo1-inducer
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Glo1-inducer Then Placebo Placebo Then Glo1-inducer
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul J Thornalley
Organization: University of Warwick
Phone: +442476968594
EMail: P.J.Thornalley@warwick.ac.uk
Publications of Results:
Xue M, Weickert MO, Qureshi S, Kandala NB, Anwar A, Waldron M, Shafie A, Messenger D, Fowler M, Jenkins G, Rabbani N, Thornalley PJ. Improved Glycemic Control and Vascular Function in Overweight and Obese Subjects by Glyoxalase 1 Inducer Formulation. Diabetes. 2016 Aug;65(8):2282-94. doi: 10.2337/db16-0153. Epub 2016 May 11.
Other Publications:
Layout table for additonal information
Responsible Party: Professor Paul J. Thornalley, University of Warwick
ClinicalTrials.gov Identifier: NCT02095873    
Other Study ID Numbers: PJT_HATFF
TSB101129 ( Other Identifier: University of Warwick )
First Submitted: March 18, 2014
First Posted: March 26, 2014
Results First Submitted: August 2, 2016
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017