Healthy Aging Through Functional Food (HATFF)

University of Warwick

Status and phase: Completed; Phase 2; Phase 1

Conditions: Aortic Stiffness; Vasodilation; Glucose Intolerance

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Glyoxalase 1 (Glo1) inducer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02095873

TSB101129 (Other Identifier)

PJT_HATFF

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups

Glo1-inducer then placebo

Experimental group

Description:

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

Treatment:

Dietary Supplement: Glyoxalase 1 (Glo1) inducer

Dietary Supplement: Placebo

Placebo then Glo1-inducer

Experimental group

Description:

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

Treatment:

Dietary Supplement: Glyoxalase 1 (Glo1) inducer

Dietary Supplement: Placebo