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Healthy Aging Through Functional Food (HATFF)

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ClinicalTrials.gov Identifier: NCT02095873
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Collaborators:
Technology Strategy Board, United Kingdom
Unilever R&D
Information provided by (Responsible Party):
Professor Paul J. Thornalley, 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.

Condition or disease Intervention/treatment Phase
Glucose Intolerance Aortic Stiffness Vasodilation Dietary Supplement: Glyoxalase 1 (Glo1) inducer Dietary Supplement: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietary Inducers of Glyoxalase-1 for Prevention and Early-stage Alleviation of Age Related Health Disorders Through Functional Foods.
Study Start Date : May 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

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

Dietary Supplement: Placebo
Mannitol, 108 mg




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095873


Locations
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United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust (UHCW)
Coventry, Warwickshire, United Kingdom, CV22DX
Sponsors and Collaborators
University of Warwick
Technology Strategy Board, United Kingdom
Unilever R&D
Investigators
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Study Chair: Paul J Thornalley, BSc PhD University of Warwick
Principal Investigator: Martin O Weickert, MD University Hospitals Coventry & Warwickshire NHS Trust
Publications of Results:
Other Publications:
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Responsible Party: Professor Paul J. Thornalley, Professor, University of Warwick
ClinicalTrials.gov Identifier: NCT02095873    
Other Study ID Numbers: PJT_HATFF
TSB101129 ( Other Identifier: University of Warwick )
First Posted: March 26, 2014    Key Record Dates
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Professor Paul J. Thornalley, University of Warwick:
Oral glucose tolerance test
Flow mediated dilatation
Aortal pulse wave velocity
Finger-fold capillary density by capillaroscopy
Additional relevant MeSH terms:
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Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents