Healthy Aging Through Functional Food

Phase 1

Completed

• Conditions: Glucose Intolerance; Aortic Stiffness; Vasodilation
• Interventions: Dietary Supplement: Glyoxalase 1 (Glo1) inducer; Dietary Supplement: Placebo

• Registration Number: NCT02095873
• Lead Sponsor: University of Warwick

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-24
• Study First Posted: 2014-03-26
• Study Start: 2014-05
• Primary Completion: 2015-02
• Study Completion: 2015-05
• Results First Submitted: 2016-08-02
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-15
• Last Update Submitted: 2017-01-15
• Results First Posted: 2017-03-06
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glo1-inducer then placebo	Placebo	Glyoxalase 1 Inducer (8 weeks), then washout (6 weeks), then Placebo (8 weeks).
Glo1-inducer then placebo	Glyoxalase 1 (Glo1) inducer	Glyoxalase 1 Inducer (8 weeks), then washout (6 weeks), then Placebo (8 weeks).
Placebo then Glo1-inducer	Glyoxalase 1 (Glo1) inducer	Placebo (8 weeks), then washout (6 weeks), then Glyoxalase 1 Inducer (8 weeks).
Placebo then Glo1-inducer	Placebo	Placebo (8 weeks), then washout (6 weeks), then Glyoxalase 1 Inducer (8 weeks).

Primary Outcome Measures

Name	Time	Method
Area Under the Curve for Oral Glucose Tolerance Test (oGGT)	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 Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals Coventry & Warwickshire NHS Trust (UHCW); 🇬🇧 Coventry, Warwickshire, United Kingdom