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Completed

NCT Number: NCT02095873

Healthy Aging Through Functional Food

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

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Key information

Conditions

Glucose Intolerance Aneurysm Aortic Stiffness Cardiovascular Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases Vasodilation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospitals Coventry & Warwickshire NHS Trust (UHCW)

Coventry, Warwickshire, CV22DX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glyoxalase 1 (Glo1) inducer

Dietary Supplement

Dietary bioactive

Other names: trans-resveratrol, 90 mg + hesperetin, 120 mg (combination)

Placebo

Dietary Supplement

Mannitol, 108 mg

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Warwick

Other

Collaborators

  • Technology Strategy Board, United Kingdom
  • Unilever R&D

Registry information

Official study title

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

Acronym: HATFF

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2014
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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