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Healthy Aging Through Functional Food (HATFF)

Primary Purpose

Glucose Intolerance, Aortic Stiffness, Vasodilation

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Glyoxalase 1 (Glo1) inducer
Placebo
Sponsored by
University of Warwick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glucose Intolerance focused on measuring Oral glucose tolerance test, Flow mediated dilatation, Aortal pulse wave velocity, Finger-fold capillary density by capillaroscopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 25 - 40 kg/m2 (>23 kg/m2 for Asians), with normal, impaired fasting or impaired postprandial glucose.
  • No other relevant morbidities.
  • Women will be preferably post-menopausal.

Exclusion Criteria:

  • Severe hypertriglyceridemia.
  • Uncontrolled hypertension, cardiovascular disease, relevant renal or hepatic disease, diabetes, and other relevant morbidity.
  • Excess alcohol consumption, smoking, acute pharmacological treatment with drugs affecting glucose metabolism such as steroids and antibiotics.
  • Anticoagulants.
  • Intake of herbal remedies.
  • Food allergies.

Sites / Locations

  • University Hospitals Coventry & Warwickshire NHS Trust (UHCW)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Glo1-inducer then placebo

Placebo then Glo1-inducer

Arm Description

Glyoxalase 1 Inducer (8 weeks), then washout (6 weeks), then Placebo (8 weeks).

Placebo (8 weeks), then washout (6 weeks), then Glyoxalase 1 Inducer (8 weeks).

Outcomes

Primary Outcome Measures

Area Under the Curve for Oral Glucose Tolerance Test (oGGT)
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.

Secondary Outcome Measures

Finger-fold Capillary Density by Capillaroscopy
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.
Flow-mediated Dilatation (FMD)
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.

Full Information

First Posted
March 18, 2014
Last Updated
January 15, 2017
Sponsor
University of Warwick
Collaborators
Technology Strategy Board, United Kingdom, Unilever R&D
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1. Study Identification

Unique Protocol Identification Number
NCT02095873
Brief Title
Healthy Aging Through Functional Food
Acronym
HATFF
Official Title
Dietary Inducers of Glyoxalase-1 for Prevention and Early-stage Alleviation of Age Related Health Disorders Through Functional Foods.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Warwick
Collaborators
Technology Strategy Board, United Kingdom, Unilever R&D

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether dietary inducers of glyoxalase 1 are effective in improving metabolic and vascular health.
Detailed Description
The aim of the study is to evaluate dietary inducers of glyoxalase 1 for effects on metabolic and vascular health in overweight volunteers at risk of developing type 2 diabetes. The research objectives are: (i) To evaluate dietary inducers of glyoxalase 1 for effects on markers of glucose metabolism during an oral glucose tolerance test (oGTT), (ii) To evaluate dietary inducers of glyoxalase 1 for effects on vascular function on three levels, using finger fold capillary density by capillaroscopy (FFCD), arterial stiffness by aortal pulse wave velocity (aPWV) and flow mediated dilatation (FMD); and effects on metabolic and pro-inflammatory markers in circulating blood and urine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance, Aortic Stiffness, Vasodilation
Keywords
Oral glucose tolerance test, Flow mediated dilatation, Aortal pulse wave velocity, Finger-fold capillary density by capillaroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glo1-inducer then placebo
Arm Type
Experimental
Arm Description
Glyoxalase 1 Inducer (8 weeks), then washout (6 weeks), then Placebo (8 weeks).
Arm Title
Placebo then Glo1-inducer
Arm Type
Experimental
Arm Description
Placebo (8 weeks), then washout (6 weeks), then Glyoxalase 1 Inducer (8 weeks).
Intervention Type
Dietary Supplement
Intervention Name(s)
Glyoxalase 1 (Glo1) inducer
Other Intervention Name(s)
trans-resveratrol, 90 mg + hesperetin, 120 mg (combination)
Intervention Description
Dietary bioactive
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Mannitol, 108 mg
Primary Outcome Measure Information:
Title
Area Under the Curve for Oral Glucose Tolerance Test (oGGT)
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)
Secondary Outcome Measure Information:
Title
Finger-fold Capillary Density by Capillaroscopy
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)
Title
Flow-mediated Dilatation (FMD)
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)
Other Pre-specified Outcome Measures:
Title
Aortal Pulse Wave Velocity (aPWV)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 25 - 40 kg/m2 (>23 kg/m2 for Asians), with normal, impaired fasting or impaired postprandial glucose. No other relevant morbidities. Women will be preferably post-menopausal. Exclusion Criteria: Severe hypertriglyceridemia. Uncontrolled hypertension, cardiovascular disease, relevant renal or hepatic disease, diabetes, and other relevant morbidity. Excess alcohol consumption, smoking, acute pharmacological treatment with drugs affecting glucose metabolism such as steroids and antibiotics. Anticoagulants. Intake of herbal remedies. Food allergies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Thornalley, BSc PhD
Organizational Affiliation
University of Warwick
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Martin O Weickert, MD
Organizational Affiliation
University Hospitals Coventry & Warwickshire NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Coventry & Warwickshire NHS Trust (UHCW)
City
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV22DX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
22188542
Citation
Xue M, Rabbani N, Momiji H, Imbasi P, Anwar MM, Kitteringham N, Park BK, Souma T, Moriguchi T, Yamamoto M, Thornalley PJ. Transcriptional control of glyoxalase 1 by Nrf2 provides a stress-responsive defence against dicarbonyl glycation. Biochem J. 2012 Apr 1;443(1):213-22. doi: 10.1042/BJ20111648.
Results Reference
background
PubMed Identifier
25666945
Citation
Rabbani N, Thornalley PJ. Dicarbonyl stress in cell and tissue dysfunction contributing to ageing and disease. Biochem Biophys Res Commun. 2015 Mar 6;458(2):221-6. doi: 10.1016/j.bbrc.2015.01.140. Epub 2015 Feb 7.
Results Reference
background
PubMed Identifier
27207552
Citation
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.
Results Reference
result

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Healthy Aging Through Functional Food

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