OverweightMICANCT03754504
Effects of Cranberry Powder Supplements on Gut Microbiota Diversity and Metabolic Syndrome
A study testing Cranberry powder in people with Overweight and Insulin Resistance, run by Laval University at 1 site in Canada.
Trial summary
It is of major importance to refine prevention strategies in order to alleviate inflammation, insulin resistance and metabolic syndrome and it appear that improving gut health and microbiota represent a promising strategy. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Insulin Resistance, Microbiota
- What is being tested?
- Cranberry powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2018to 1 Mar 2020
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- overweight
- fasting insulin > 42 pmol/L
- non smoking
- Stable weight in the past 3 months
Who cannot join
- chronic diseases
- Taking drugs that could affect glucose or lipid metabolism
- Taking anti-inflammatory, immunosuppressant or anticoagulant drugs
- Inflammatory bowel disease
- vegetarians, vegan or following any restrictive dietary pattern or if they are big consumers of berries (>1 portion/day)
- taking pre- and probiotics
Show all 9Show fewer
- antibiotics in the past 3 months or change in their regular medication
- Major surgery in the past 3 months
- taste aversion for cranberries or cranberry allergy or allergies to other ingredients used in the placebo
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut sur la nutrition et les aliments fonctionnels
Québec, G1V 0A6
About this study
Official title: Evaluation of the Effect of Cranberry Whole Fruit Powder on Gut Microbiota Diversity, Intestinal Health and Metabolic Syndrome in Overweight Individuals: a Proof-of-concept Study
It is of major importance to refine prevention strategies in order to alleviate inflammation, insulin resistance and metabolic syndrome and it appear that improving gut health and microbiota represent a promising strategy. Cranberry-enriched diets may help prevent metabolic syndrome and its associated chronic diseases by a protective effect of gut health and microbiota. It is therefore highly relevant to test the hypothesis that a whole cranberry powder supplements (which include a mixture of polyphenols, free and fiber-associated proanthocyanidins, and fruits fibers) is associated with changes on the gut health and microbiota playing a major role in alleviating inflammation and obesity-associated metabolic disorders.
Read the detailed description
Over the past decade it has become clear that the gut microbiota is a key determinant of obesity and that its perturbations by nutritional insults play a significant role in the development of metabolic complications such as insulin resistance, type 2 diabetes, cardiovascular diseases and non-alcoholic fatty liver disease. Indeed, there is growing amounts of studies that have shown that dysbiosis of the intestinal microbiota promotes obesity-linked chronic inflammation, and is causally related to diet-induced type 2 diabetes. Our group recently published that a polyphenol-rich cranberry extract exert striking effect on the gut microbiota of high-fat and high-sucrose fed mice, which was associated with prevention of diet-induced weight gain, visceral obesity, insulin resistance and hepatic steatosis. Notably, metagenomic analyses of feces of the cranberry extract-treated mice suggested that these metabolic effects were associated with a dramatic increase in the proportion of Akkermansia muciniphila, a dominant commensal bacterium in the intestinal mucus layer which has received particular attention in the last few years since its abundance is associated with improved metabolic health and beneficial responses to various interventions in both mice and humans with obesity and diabetes. Polyphenols are now recognized as potent molecules capable to protect against obesity-linked metabolic diseases and dysbiosis. Among polyphenols, there is increasing evidence supporting the beneficial impact of dietary proanthocyanidins. Cranberries being rich in proanthocyanidins, we believe that these phyto-elements could be associated to their beneficial effects. On the other hand, apart from the recognized beneficial effects of fibers on gut health, their association with high molecular proanthocyanidins could also contribute to their health benefits.
The main objective of this study is to investigate in a cross-over randomized placebo-controlled clinical trial the beneficial properties of a whole cranberry powder on gut microbiota, intestinal health and metabolic syndrome parameters in overweight men.
- Conditions
- Overweight, Insulin Resistance, Microbiota, Endotoxemia, Metabolic Syndrome
- Being tested
- Cranberry powder, Placebo
- Medical subject headings
- Overweight, Insulin Resistance, Endotoxemia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry powderDietary supplement
3 capsules /day of whole cranberry powder (500mg/each)
PlaceboDietary supplement
3 capsules/day of a placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Cranberry | Experimental | Whole Cranberry Powder Supplements Receives: Dietary Supplement: Cranberry powder |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gut Microbiota Diversity
Global variation of the fecal microbiota
Measured: At the beginning and the end of each treatment (4 weeks each)
Secondary outcomes (8)
Change in Endotoxemia
Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)
Measured: At the beginning and the end of each treatment (4 weeks each)
Change in Intestinal permeability
Plasma zonulin
Measured: At the beginning and the end of each treatment (4 weeks each)
Change in Inflammation state of the tissue
Fecal calprotectin and chromogranin
Measured: At the beginning and the end of each treatment (4 weeks each)
Change in Short chain fatty acids in the feces
Measure short chain fatty acids in the feces
Measured: At the beginning and the end of each treatment (4 weeks each)
Change in Gut health and stool consistency
Evaluation of gastrointestinal symptoms and stool consistency using standardized questionnaires
Measured: At the beginning and the end of each treatment (4 weeks each)
Change in Lipid profile
Evaluation of plasma triglycerides (TG), Total cholesterol, LDL, HDL and Apolipoprotein B from the beginning to the end of two dietary treatment
Measured: At the beginning and the end of each treatment (4 weeks each)
Change in chronic inflammation
Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP)
Measured: At the beginning and the end of each treatment (4 weeks each)
Change in Glucose homeostasis
Evaluation of plasma fasting glucose and insulin concentration
Measured: At the beginning and the end of each treatment (4 weeks each)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start15 Oct 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Naturex
- Responsible party
- Principal investigator, André Marette, Laval University
- Investigators
- André Marette, Ph.D, Principal investigator, Institute of nutrition and functional foods, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754504
- Sponsor's protocol ID
- MICA 2018-146
- Acronym
- MICA
- Status last verified
- Mar 2020
- First submitted
- 19 Nov 2018
- Last updated
- 30 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Cranberry Whole Fruit Powder on Gut Microbiota Diversity, Intestinal Health and Metabolic Syndrome in Overweight Individuals: a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT03754504
- Acronym / sponsor ID
- MICA / MICA 2018-146
- Conditions
- Overweight, Insulin Resistance, Microbiota, Endotoxemia, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Naturex
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 27 Nov 2018 (actual)
- 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.
It is of major importance to refine prevention strategies in order to alleviate inflammation, insulin resistance and metabolic syndrome and it appear that improving gut health and microbiota represent a promising strategy. Cranberry-enriched diets may help prevent metabolic syndrome and its associated chronic diseases by a protective effect of gut health and microbiota. It is therefore highly relevant to test the hypothesis that a whole cranberry powder supplements (which include a mixture of polyphenols, free and fiber-associated proanthocyanidins, and fruits fibers) is associated with changes on the gut health and microbiota playing a major role in alleviating inflammation and obesity-associated metabolic disorders.
Detailed description
Over the past decade it has become clear that the gut microbiota is a key determinant of obesity and that its perturbations by nutritional insults play a significant role in the development of metabolic complications such as insulin resistance, type 2 diabetes, cardiovascular diseases and non-alcoholic fatty liver disease. Indeed, there is growing amounts of studies that have shown that dysbiosis of the intestinal microbiota promotes obesity-linked chronic inflammation, and is causally related to diet-induced type 2 diabetes. Our group recently published that a polyphenol-rich cranberry extract exert striking effect on the gut microbiota of high-fat and high-sucrose fed mice, which was associated with prevention of diet-induced weight gain, visceral obesity, insulin resistance and hepatic steatosis. Notably, metagenomic analyses of feces of the cranberry extract-treated mice suggested that these metabolic effects were associated with a dramatic increase in the proportion of Akkermansia muciniphila, a dominant commensal bacterium in the intestinal mucus layer which has received particular attention in the last few years since its abundance is associated with improved metabolic health and beneficial responses to various interventions in both mice and humans with obesity and diabetes. Polyphenols are now recognized as potent molecules capable to protect against obesity-linked metabolic diseases and dysbiosis. Among polyphenols, there is increasing evidence supporting the beneficial impact of dietary proanthocyanidins. Cranberries being rich in proanthocyanidins, we believe that these phyto-elements could be associated to their beneficial effects. On the other hand, apart from the recognized beneficial effects of fibers on gut health, their association with high molecular proanthocyanidins could also contribute to their health benefits.
The main objective of this study is to investigate in a cross-over randomized placebo-controlled clinical trial the beneficial properties of a whole cranberry powder on gut microbiota, intestinal health and metabolic syndrome parameters in overweight men.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry | Experimental | Dietary Supplement: Cranberry powderWhole Cranberry Powder Supplements |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- overweight
- fasting insulin > 42 pmol/L
- non smoking
- Stable weight in the past 3 months
Key exclusion criteria (9 listed)
- chronic diseases
- Taking drugs that could affect glucose or lipid metabolism
- Taking anti-inflammatory, immunosuppressant or anticoagulant drugs
- Inflammatory bowel disease
- vegetarians, vegan or following any restrictive dietary pattern or if they are big consumers of berries (>1 portion/day)
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 |
|---|---|---|
| Cranberry powder3 capsules /day of whole cranberry powder (500mg/each) | Dietary supplement | Cranberry |
| Placebo3 capsules/day of a placebo comparator | Dietary supplement | Placebo |
Primary outcome
Change in Gut Microbiota Diversity
Time frame: At the beginning and the end of each treatment (4 weeks each)
Global variation of the fecal microbiota
8 secondary outcomes
Change in Endotoxemia
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in Intestinal permeability
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in Inflammation state of the tissue
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in Short chain fatty acids in the feces
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in Gut health and stool consistency
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in Lipid profile
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in chronic inflammation
Time frame: At the beginning and the end of each treatment (4 weeks each)
Change in Glucose homeostasis
Time frame: At the beginning and the end of each treatment (4 weeks each)
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 30 Mar 2020.
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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.
André Marette, Ph.D principal investigator
Institute of nutrition and functional foods, Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry powder in people with Overweight and Insulin Resistance, 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 9 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 30 Mar 2020. 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 Gut Microbiota Diversity (time frame: At the beginning and the end of each treatment (4 weeks each)). 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 30 Mar 2020.