Healthy Aging Through Functional Food

Phase 2CompletedNCT02095873

University of Warwick32 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Glucose Intolerance Aortic Stiffness Vasodilation

Interventions

Glyoxalase 1 (Glo1) inducerDIETARY_SUPPLEMENT

Dietary bioactive

PlaceboDIETARY_SUPPLEMENT

Mannitol, 108 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University Hospitals Coventry & Warwickshire NHS Trust (UHCW)

Coventry, Warwickshire, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)

Secondary Outcomes

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.

Time frame: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)

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.

Time frame: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)

Data from ClinicalTrials.gov

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