Clinical trial NCT02095873: Healthy Aging Through Functional Food
Official title: Dietary Inducers of Glyoxalase-1 for Prevention and Early-stage Alleviation of Age Related Health Disorders Through Functional Foods.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glucose Intolerance
Aortic Stiffness
Vasodilation
Keywords: Oral glucose tolerance test
Flow mediated dilatation
Aortal pulse wave velocity
Finger-fold capillary density by capillaroscopy
Lead sponsor: University of Warwick
Sponsor class: OTHER
Collaborators: name: Technology Strategy Board, United Kingdom
name: Unilever R&D
First posted: 2014-03-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Area Under the Curve for Oral Glucose Tolerance Test (oGGT)
timeFrame: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Secondary outcomes:
measure: Finger-fold Capillary Density by Capillaroscopy
timeFrame: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
measure: Flow-mediated Dilatation (FMD)
timeFrame: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Other outcomes:
measure: Aortal Pulse Wave Velocity (aPWV)
timeFrame: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Locations:
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwickshire NHS Trust (UHCW)
state: Warwickshire
Study officials:
affiliation: University of Warwick
name: Paul J Thornalley, BSc PhD
role: STUDY_CHAIR
affiliation: University Hospitals Coventry & Warwickshire NHS Trust
name: Martin O Weickert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.