NCT02095873: HATFF

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

Completed Phase 1/Phase 2 Results posted Last updated 15 January 2017

What this trial tests

Phase 1/Phase 2 trial testing Glyoxalase 1 (Glo1) inducer in Glucose Intolerance in 32 participants. Completed in 1 May 2015.

Timeline

1 May 2014

Primary endpoint
1 February 2015

1 May 2015

Quick facts

Lead sponsor	University of Warwick
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	32
Start date	1 May 2014
Primary completion	1 February 2015
Estimated completion	1 May 2015
Sites	1 location across United Kingdom

Drugs / interventions tested

• Glyoxalase 1 (Glo1) inducer
• Placebo

Conditions studied

• Glucose Intolerance — all drugs for Glucose Intolerance →
• Aortic Stiffness — all drugs for Aortic Stiffness →
• Vasodilation — all drugs for Vasodilation →

Sponsor

University of Warwick

Who can join

Adults 18 to 80, any sex, with Glucose Intolerance or Aortic Stiffness. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. SIRT1 Activation by Natural Phytochemicals: An Overview.
   Iside C, Scafuro M, Nebbioso A, Altucci L. · · 2020 · cited 204× · PMID 32848804 · DOI 10.3389/fphar.2020.01225
2. Dicarbonyls and glyoxalase in disease mechanisms and clinical therapeutics.
   Rabbani N, Xue M, Thornalley PJ. · · 2016 · cited 128× · PMID 27406712 · DOI 10.1007/s10719-016-9705-z
3. Mitochondrial complex I as a therapeutic target for Alzheimer's disease.
   Trushina E, Trushin S, Hasan MF. · · 2022 · cited 94× · PMID 35256930 · DOI 10.1016/j.apsb.2021.11.003
4. Dicarbonyl stress in clinical obesity.
   Masania J, Malczewska-Malec M, Razny U, Goralska J, et al · · 2016 · cited 59× · PMID 27338619 · DOI 10.1007/s10719-016-9692-0
5. Reversal of Insulin Resistance in Overweight and Obese Subjects by <i>trans</i>-Resveratrol and Hesperetin Combination-Link to Dysglycemia, Blood Pressure, Dyslipidemia, and Low-Grade Inflammation.
   Rabbani N, Xue M, Weickert MO, Thornalley PJ. · · 2021 · cited 48× · PMID 34371884 · DOI 10.3390/nu13072374
6. Emerging Glycation-Based Therapeutics-Glyoxalase 1 Inducers and Glyoxalase 1 Inhibitors.
   Rabbani N, Thornalley PJ. · · 2022 · cited 34× · PMID 35269594 · DOI 10.3390/ijms23052453
7. Quantitative and Systems Pharmacology 3. Network-Based Identification of New Targets for Natural Products Enables Potential Uses in Aging-Associated Disorders.
   Fang J, Gao L, Ma H, Wu Q, et al · · 2017 · cited 28× · PMID 29093681 · DOI 10.3389/fphar.2017.00747
8. Rejuvenation: Turning Back Time by Enhancing CISD2.
   Yeh CH, Shen ZQ, Lin CC, Lu CK, et al · · 2022 · cited 19× · PMID 36430496 · DOI 10.3390/ijms232214014