Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
32 participants
INTERVENTIONAL
2014-05-31
2015-05-31
Brief Summary
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Detailed Description
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(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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Glo1-inducer then placebo
Glyoxalase 1 Inducer (8 weeks), then washout (6 weeks), then Placebo (8 weeks).
Glyoxalase 1 (Glo1) inducer
Dietary bioactive
Placebo
Mannitol, 108 mg
Placebo then Glo1-inducer
Placebo (8 weeks), then washout (6 weeks), then Glyoxalase 1 Inducer (8 weeks).
Glyoxalase 1 (Glo1) inducer
Dietary bioactive
Placebo
Mannitol, 108 mg
Interventions
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Glyoxalase 1 (Glo1) inducer
Dietary bioactive
Placebo
Mannitol, 108 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No other relevant morbidities.
* Women will be preferably post-menopausal.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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Technology Strategy Board, United Kingdom
OTHER
Unilever R&D
INDUSTRY
University of Warwick
OTHER
Responsible Party
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Professor Paul J. Thornalley
Professor
Principal Investigators
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Paul J Thornalley, BSc PhD
Role: STUDY_CHAIR
University of Warwick
Martin O Weickert, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Coventry & Warwickshire NHS Trust
Locations
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University Hospitals Coventry & Warwickshire NHS Trust (UHCW)
Coventry, Warwickshire, United Kingdom
Countries
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References
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Xue M, Rabbani N, Momiji H, Imbasi P, Anwar MM, Kitteringham N, Park BK, Souma T, Moriguchi T, Yamamoto M, Thornalley PJ. Transcriptional control of glyoxalase 1 by Nrf2 provides a stress-responsive defence against dicarbonyl glycation. Biochem J. 2012 Apr 1;443(1):213-22. doi: 10.1042/BJ20111648.
Rabbani N, Thornalley PJ. Dicarbonyl stress in cell and tissue dysfunction contributing to ageing and disease. Biochem Biophys Res Commun. 2015 Mar 6;458(2):221-6. doi: 10.1016/j.bbrc.2015.01.140. Epub 2015 Feb 7.
Xue M, Weickert MO, Qureshi S, Kandala NB, Anwar A, Waldron M, Shafie A, Messenger D, Fowler M, Jenkins G, Rabbani N, Thornalley PJ. Improved Glycemic Control and Vascular Function in Overweight and Obese Subjects by Glyoxalase 1 Inducer Formulation. Diabetes. 2016 Aug;65(8):2282-94. doi: 10.2337/db16-0153. Epub 2016 May 11.
Other Identifiers
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TSB101129
Identifier Type: OTHER
Identifier Source: secondary_id
PJT_HATFF
Identifier Type: -
Identifier Source: org_study_id
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