Glucose IntolerancePhase 1/2HATFFNCT02095873
Healthy Aging Through Functional Food
A Phase 1/2 study testing Glyoxalase 1 (Glo1) inducer in people with Glucose Intolerance and Aortic Stiffness, run by University of Warwick at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether dietary inducers of glyoxalase 1 are effective in improving metabolic and vascular health. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance, Aortic Stiffness, Vasodilation
- What is being tested?
- Glyoxalase 1 (Glo1) inducer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to May 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Coventry & Warwickshire NHS Trust (UHCW)
Coventry, Warwickshire, CV22DX
About this study
Official title: Dietary Inducers of Glyoxalase-1 for Prevention and Early-stage Alleviation of Age Related Health Disorders Through Functional Foods.
The purpose of this study is to determine whether dietary inducers of glyoxalase 1 are effective in improving metabolic and vascular health.
Read the 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.
- Conditions
- Glucose Intolerance, Aortic Stiffness, Vasodilation
- Being tested
- Glyoxalase 1 (Glo1) inducer, Placebo
- Keywords
- Oral glucose tolerance test, Flow mediated dilatation, Aortal pulse wave velocity, Finger-fold capillary density by capillaroscopy
- Medical subject headings
- Glucose Intolerance, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glyoxalase 1 (Glo1) inducerDietary supplement
Also called trans-resveratrol, 90 mg + hesperetin, 120 mg (combination)
Dietary bioactive
PlaceboDietary supplement
Mannitol, 108 mg
| Study group | Role | What they receive |
|---|---|---|
| Glo1-inducer then placebo | Experimental | Glyoxalase 1 Inducer (8 weeks), then washout (6 weeks), then Placebo (8 weeks). Receives: Dietary Supplement: Glyoxalase 1 (Glo1) inducer; Dietary Supplement: Placebo |
| Placebo then Glo1-inducer | Experimental | Placebo (8 weeks), then washout (6 weeks), then Glyoxalase 1 Inducer (8 weeks). Receives: Dietary Supplement: Glyoxalase 1 (Glo1) inducer; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Secondary outcomes (2)
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.
Measured: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
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.
Measured: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warwick
- Sponsor type
- University, hospital or other
- Collaborators
- Technology Strategy Board, United Kingdom, Unilever R&D
- Responsible party
- Principal investigator, Professor Paul J. Thornalley, University of Warwick
- Investigators
- Paul J Thornalley, BSc PhD, Study chair, University of WarwickMartin O Weickert, MD, Principal investigator, University Hospitals Coventry & Warwickshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095873
- Sponsor's protocol ID
- PJT_HATFF
- Other IDs
- TSB101129
- Acronym
- HATFF
- Status last verified
- Jan 2017
- First submitted
- 18 Mar 2014
- Last updated
- 6 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 22188542Rabbani 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.
PubMed 25666945Xue 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.
PubMed 27207552
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Inducers of Glyoxalase-1 for Prevention and Early-stage Alleviation of Age Related Health Disorders Through Functional Foods.
- ClinicalTrials.gov ID
- NCT02095873
- Acronym / sponsor ID
- HATFF / PJT_HATFF
- Conditions
- Glucose Intolerance, Aortic Stiffness, Vasodilation
- Keywords
- Oral glucose tolerance test, Flow mediated dilatation, Aortal pulse wave velocity, Finger-fold capillary density by capillaroscopy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of WarwickUniversity, hospital or other
- Collaborators
- Technology Strategy Board, United Kingdom, Unilever R&D
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 6 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glo1-inducer then placebo | Experimental | Dietary Supplement: Glyoxalase 1 (Glo1) inducer, Dietary Supplement: PlaceboGlyoxalase 1 Inducer (8 weeks), then washout (6 weeks), then Placebo (8 weeks). |
| Placebo then Glo1-inducer | Experimental | Dietary Supplement: Glyoxalase 1 (Glo1) inducer, Dietary Supplement: PlaceboPlacebo (8 weeks), then washout (6 weeks), then Glyoxalase 1 Inducer (8 weeks). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glyoxalase 1 (Glo1) inducerAlso: trans-resveratrol, 90 mg + hesperetin, 120 mg (combination)Dietary bioactive | Dietary supplement | Glo1-inducer then placebo, Placebo then Glo1-inducer |
| PlaceboMannitol, 108 mg | Dietary supplement | Glo1-inducer then placebo, Placebo then Glo1-inducer |
Primary outcome
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 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.
2 secondary outcomes
Finger-fold Capillary Density by Capillaroscopy
Time frame: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Flow-mediated Dilatation (FMD)
Time frame: Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22188542Xue 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.
- Background: PubMed 25666945Rabbani 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.
- Results publication: PubMed 27207552Xue 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Thornalley, BSc PhD study chair
University of Warwick
Martin O Weickert, MD principal investigator
University Hospitals Coventry & Warwickshire NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Glyoxalase 1 (Glo1) inducer in people with Glucose Intolerance and Aortic Stiffness, run by University of Warwick at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02095873, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.