Healthy Aging Through Functional Food
HATFF
Dietary Inducers of Glyoxalase-1 for Prevention and Early-stage Alleviation of Age Related Health Disorders Through Functional Foods.
2 other identifiers
interventional
32
1 country
1
Brief Summary
The purpose of this study is to determine whether dietary inducers of glyoxalase 1 are effective in improving metabolic and vascular health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
March 6, 2017
CompletedMarch 6, 2017
January 1, 2017
9 months
March 18, 2014
August 2, 2016
January 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under the Curve for 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.
Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Secondary Outcomes (2)
Finger-fold Capillary Density by Capillaroscopy
Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Flow-mediated Dilatation (FMD)
Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Other Outcomes (1)
Aortal Pulse Wave Velocity (aPWV)
Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Study Arms (2)
Glo1-inducer then placebo
EXPERIMENTALGlyoxalase 1 Inducer (8 weeks), then washout (6 weeks), then Placebo (8 weeks).
Placebo then Glo1-inducer
EXPERIMENTALPlacebo (8 weeks), then washout (6 weeks), then Glyoxalase 1 Inducer (8 weeks).
Interventions
Dietary bioactive
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Warwicklead
- Technology Strategy Board, United Kingdomcollaborator
- Unilever R&Dcollaborator
Study Sites (1)
University Hospitals Coventry & Warwickshire NHS Trust (UHCW)
Coventry, Warwickshire, CV22DX, United Kingdom
Related Publications (3)
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.
PMID: 22188542BACKGROUNDRabbani 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.
PMID: 25666945BACKGROUNDXue 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.
PMID: 27207552RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Paul J Thornalley
- Organization
- University of Warwick
Study Officials
- STUDY CHAIR
Paul J Thornalley, BSc PhD
University of Warwick
- PRINCIPAL INVESTIGATOR
Martin O Weickert, MD
University Hospitals Coventry & Warwickshire NHS Trust
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 18, 2014
First Posted
March 26, 2014
Study Start
May 1, 2014
Primary Completion
February 1, 2015
Study Completion
May 1, 2015
Last Updated
March 6, 2017
Results First Posted
March 6, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share