Healthy Aging Through Functional Food (HATFF)

January 15, 2017 updated by: Professor Paul J. Thornalley, University of Warwick

Dietary Inducers of Glyoxalase-1 for Prevention and Early-stage Alleviation of Age Related Health Disorders Through Functional Foods.

The purpose of this study is to determine whether dietary inducers of glyoxalase 1 are effective in improving metabolic and vascular health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV22DX
        • University Hospitals Coventry & Warwickshire NHS Trust (UHCW)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Glo1-inducer then placebo
Glyoxalase 1 Inducer (8 weeks), then washout (6 weeks), then Placebo (8 weeks).
Dietary supplement: Glyoxalase 1 (Glo1) inducer
Dietary bioactive
Other Names:
  • trans-resveratrol, 90 mg + hesperetin, 120 mg (combination)
Dietary supplement: Placebo
Mannitol, 108 mg
EXPERIMENTAL: Placebo then Glo1-inducer
Placebo (8 weeks), then washout (6 weeks), then Glyoxalase 1 Inducer (8 weeks).
Dietary supplement: Glyoxalase 1 (Glo1) inducer
Dietary bioactive
Other Names:
  • trans-resveratrol, 90 mg + hesperetin, 120 mg (combination)
Dietary supplement: Placebo
Mannitol, 108 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve for Oral Glucose Tolerance Test (oGGT)
Time Frame: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
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.
Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Finger-fold Capillary Density by Capillaroscopy
Time Frame: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
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.
Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Flow-mediated Dilatation (FMD)
Time Frame: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
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.
Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aortal Pulse Wave Velocity (aPWV)
Time Frame: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Aortal pulse wave velocity is measured by a non-invasive oscillometric device.
Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Warwick

Collaborators

Unilever R&D
Technology Strategy Board, United Kingdom

Investigators

  • Study Chair: Paul J Thornalley, BSc PhD, University of Warwick
  • Principal Investigator: Martin O Weickert, MD, University Hospitals Coventry & Warwickshire NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (ESTIMATE)

March 26, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 6, 2017

Last Update Submitted That Met QC Criteria

January 15, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PJT_HATFF
  • TSB101129 (OTHER: University of Warwick)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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