DiabetesNCT01766570
Beneficial Effects of a Polyphenol Enriched Beverage on Type 2 Diabetes Prevention and on Cardiovascular Risk Profile of Men and Women With Insulin Resistance.
A study of Diabetes and Cardiovascular Disease, run by Laval University at 1 site in Canada.
Trial summary
The purpose of this study is to measure the beneficial effects of an optimized berries extracts on diabetes and cardiovascular diseases prevention. Our hypothesis is that including a polyphenol rich berries extract in daily feeding will improve insulin sensitivity, glucose tolerance, pancreatic β-cells function… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetes, Cardiovascular Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40-65 year old
- non-smoking
- overweight (BMI>27)
- insulin resistant (fasting insulin >90pmol/L, with fasting glycemia < 7,0 mmol/L and < 11,1 mmol/L after a 120-min oral glucose tolerance test)
Who cannot join
- diabetes
- chronic diseases
- taking drugs that could affect glucose or lipids metabolism
- major surgery 3 months prior to the study
- weight variation of ±10% 6 months prior to the study
- strawberry or cranberry allergy
- consumption of berries rich in polyphenol and/or wine more then 3 times per week
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutraceuticals and Functional Foods (INAF), Laval University
Québec, Quebec, G1V 0A6
About this study
The purpose of this study is to measure the beneficial effects of an optimized berries extracts on diabetes and cardiovascular diseases prevention. Our hypothesis is that including a polyphenol rich berries extract in daily feeding will improve insulin sensitivity, glucose tolerance, pancreatic β-cells function, lipids and inflammatory profile, and oxidative stress markers.
Read the detailed description
Type 2 diabetes is an up rising disease that makes it a major public health problem. While 221 millions cases were estimated in 2010, the prevalence would be 366 millions in 2030. It is well recognized that regular consumption of fruits and vegetables can lower the incidence of chronic diseases such as cancer, cardiovascular diseases, diabetes and inflammatory diseases. Recently, Drs Desjardins, Abrams and Marette's research team discovered a high amount of a sesquiterpene in berries. This molecule is recognized for its ability to improve glucose tolerance and insulin sensitivity, and to lower pro-inflammatory profile of obese mice. The aim of this study is to determine the effect of a polyphenol rich berries extract mix on insulin sensitivity, glucose tolerance, pancreatic β-cells function, lipids and inflammatory profile, and oxidative stress markers, on human obese subjects that have insulin resistance.
- Conditions
- Diabetes, Cardiovascular Disease
- Being tested
- Uncontrolled nutritional intervention with a supplemental beverage, Placebo
- Keywords
- insulin sensitivity,, glucose tolerance,, inflammatory markers,, lipid profile,, oxidative stress,, pancreatic β-cell function
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncontrolled nutritional intervention with a supplemental beverageOther
Men and women are assigned to an uncontrolled nutritional intervention where they have to consume every day one of the beverage. Half of the subjects consume the experimental beverage containing polyphenols from berries extracts, the other half consume a placebo beverage without polyphenols. The polyphenol containing beverage daily supply 1,84 g of a strawberry and cranberry extract. This amount give the equivalent of 333 mg of polyphenols, thus corresponding to a daily consumption of one cup of berries. The placebo beverage is also a fruit taste beverage, but without polyphenols. Both beverage are isocaloric, with same appearance and taste. A 2 weeks stabilisation period precede the 6 weeks experimental period. During these two periods, subjects are advise to maintain their habitual caloric intake and their habitual activity level, and to avoid consumption of particular food with a high polyphenol content.
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Phenol | Experimental | Men and women who are assigned to a 6 weeks experimental period where they consume the rich polyphenol berries extract mix. Receives: Other: Uncontrolled nutritional intervention with a supplemental beverage |
| Control | Placebo comparator | Men and women who are assigned to a 6 weeks experimental period where they consume a placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiometabolic statute from baseline to the end of intervention.
glucose and insulin concentrations during a 120-min euglycemic-hyperinsulinemic clamp, glucose and insulin concentrations during a 120-min oral glucose tolerance test, insulin sensitivity, c-peptide, C-reactive protein (hs-CRP), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha) and plasminogen activator inhibitor-1 (PAI-1) levels, triglycerides, total cholesterol, very low density lipoprotein cholesterol (cVLDL), low density lipoprotein cholesterol (cLDL), high density lipoprotein cholesterol (cHDL), apolipoprotein A-1 and B, oxidized-LDL, glucose disposition rate (GDR), insulin sensitivity measure (MI), beta-cells function
Measured: At baseline (at the beginning of the intervention), and at the end of the intervention (6 weeks)
Secondary outcomes (3)
Change in nutritional variables from baseline to the end of the intervention.
Food frequency questionnaire
Measured: At baseline, and at the end of the intervention period (6 weeks)
Change in physical activity habits from baseline to the end of the intervention.
Physical activity habits questionnaire
Measured: ) At baseline, and at the end of the intervention period (6 weeks)
Change in anthropometric measurements from baseline to the end of the intervention.
anthropometric measurements (body mass index, waist and hip circumferences)
Measured: At baseline, and at the end of the intervention period (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Consortium de recherche et innovations en bioprocédés industriels au Québec (CRIBIQ), Institute of Nutraceuticals and Functional Foods
- Responsible party
- Principal investigator, Helene Jacques, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766570
- Sponsor's protocol ID
- PHENOL-C11-12-155
- Status last verified
- Sep 2015
- First submitted
- 2 Oct 2012
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of a Polyphenol Enriched Beverage on Type 2 Diabetes Prevention and on Cardiovascular Risk Profile of Men and Women With Insulin Resistance.
- ClinicalTrials.gov ID
- NCT01766570
- Acronym / sponsor ID
- PHENOL-C11-12-155
- Conditions
- Diabetes, Cardiovascular Disease
- Keywords
- insulin sensitivity,, glucose tolerance,, inflammatory markers,, lipid profile,, oxidative stress,, pancreatic β-cell function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Consortium de recherche et innovations en bioprocédés industriels au Québec (CRIBIQ), Institute of Nutraceuticals and Functional Foods
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
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 measure the beneficial effects of an optimized berries extracts on diabetes and cardiovascular diseases prevention. Our hypothesis is that including a polyphenol rich berries extract in daily feeding will improve insulin sensitivity, glucose tolerance, pancreatic β-cells function, lipids and inflammatory profile, and oxidative stress markers.
Detailed description
Type 2 diabetes is an up rising disease that makes it a major public health problem. While 221 millions cases were estimated in 2010, the prevalence would be 366 millions in 2030. It is well recognized that regular consumption of fruits and vegetables can lower the incidence of chronic diseases such as cancer, cardiovascular diseases, diabetes and inflammatory diseases. Recently, Drs Desjardins, Abrams and Marette's research team discovered a high amount of a sesquiterpene in berries. This molecule is recognized for its ability to improve glucose tolerance and insulin sensitivity, and to lower pro-inflammatory profile of obese mice. The aim of this study is to determine the effect of a polyphenol rich berries extract mix on insulin sensitivity, glucose tolerance, pancreatic β-cells function, lipids and inflammatory profile, and oxidative stress markers, on human obese subjects that have insulin resistance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenol | Experimental | Other: Uncontrolled nutritional intervention with a supplemental beverageMen and women who are assigned to a 6 weeks experimental period where they consume the rich polyphenol berries extract mix. |
| Control | Placebo comparator | Other: PlaceboMen and women who are assigned to a 6 weeks experimental period where they consume a placebo. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 40-65 year old
- non-smoking
- overweight (BMI>27)
- insulin resistant (fasting insulin >90pmol/L, with fasting glycemia < 7,0 mmol/L and < 11,1 mmol/L after a 120-min oral glucose tolerance test)
Key exclusion criteria (7 listed)
- diabetes
- chronic diseases
- taking drugs that could affect glucose or lipids metabolism
- major surgery 3 months prior to the study
- weight variation of ±10% 6 months prior to the study
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 |
|---|---|---|
| Uncontrolled nutritional intervention with a supplemental beverageMen and women are assigned to an uncontrolled nutritional intervention where they have to consume every day one of the beverage. Half of the subjects consume the experimental beverage containing polyphenols from berries extracts, the other half consume a placebo beverage without polyphenols. The polyphenol containing beverage daily supply 1,84 g of a strawberry and cranberry extract. This amount give the equivalent of 333 mg of polyphenols, thus corresponding to a daily consumption of one cup of berries. The placebo beverage is also a fruit taste beverage, but without polyphenols. Both beverage are isocaloric, with same appearance and taste. A 2 weeks stabilisation period precede the 6 weeks experimental period. During these two periods, subjects are advise to maintain their habitual caloric intake and their habitual activity level, and to avoid consumption of particular food with a high polyphenol content. | Other | Phenol |
| Placebo | Other | Control |
Primary outcome
Change in cardiometabolic statute from baseline to the end of intervention.
Time frame: At baseline (at the beginning of the intervention), and at the end of the intervention (6 weeks)
glucose and insulin concentrations during a 120-min euglycemic-hyperinsulinemic clamp, glucose and insulin concentrations during a 120-min oral glucose tolerance test, insulin sensitivity, c-peptide, C-reactive protein (hs-CRP), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha) and plasminogen activator inhibitor-1 (PAI-1) levels, triglycerides, total cholesterol, very low density lipoprotein cholesterol (cVLDL), low density lipoprotein cholesterol (cLDL), high density lipoprotein cholesterol (cHDL), apolipoprotein A-1 and B, oxidized-LDL, glucose disposition rate (GDR), insulin sensitivity measure (MI), beta-cells function
3 secondary outcomes
Change in nutritional variables from baseline to the end of the intervention.
Time frame: At baseline, and at the end of the intervention period (6 weeks)
Change in physical activity habits from baseline to the end of the intervention.
Time frame: ) At baseline, and at the end of the intervention period (6 weeks)
Change in anthropometric measurements from baseline to the end of the intervention.
Time frame: At baseline, and at the end of the intervention period (6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetes and Cardiovascular Disease, run by Laval University at 1 site in Canada.
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 4 inclusion and 7 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 2 Sep 2015. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in cardiometabolic statute from baseline to the end of intervention. (time frame: At baseline (at the beginning of the intervention), and at the end of the intervention (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2015.