Healthy Aging Through Functional Food

Glucose Intolerance Clinical Trial

— HATFF  

Official title:

Dietary Inducers of Glyoxalase-1 for Prevention and Early-stage Alleviation of Age Related Health Disorders Through Functional Foods.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095873
• Other study ID #: PJT_HATFF
• Secondary ID: TSB101129
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 18, 2014
• Last updated: June 8, 2015
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: University of Warwick
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Research Councils UKUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Stiffness
• Glucose Intolerance
• Vasodilation

Intervention

Dietary Supplement:
• Glyoxalase 1 inducer
Dietary bioactive
• Placebo
Mannitol, 210 mg

Locations

Country	Name	City	State
United Kingdom	University Hospitals Coventry & Warwickshire NHS Trust (UHCW)	Coventry	Warwickshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Warwick	Technology Strategy Board, United Kingdom, Unilever R&D

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in aortal pulse wave velocity (aPWV)	Aortal pulse wave velocity is measured by a non-invasive oscillometric device.	0, 8, 14 and 22 weeks	No
Other	Change in flow-mediated dilatation (FMD)	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.	0, 8, 14 and 22 weeks	No
Primary	Change in oral glucose tolerance test (oGGT)	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.	Weeks 0, 8, 14 and 22	No
Secondary	Change in finger-fold capillary density by capillaroscopy	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.	0, 8, 14 and 22 weeks	No