EndotoxemiaPhenulinNCT03800277
Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health
A study testing Cranberry and Agaves in people with Endotoxemia and Metabolic Syndrome, run by Laval University at 1 site in Canada.
Trial summary
The growing prevalence of obesity and type 2 diabetes (T2D) is a major public health problem. Recent studies have clearly established that the gut microbiota plays a key role in the investigator's propensity to develop obesity and associated metabolic health disorders. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotoxemia, Metabolic Syndrome, Glucose Metabolism Disorders
- What is being tested?
- Cranberry and Agaves
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteCanada
- Study dates
- 5 Nov 2018to 31 Dec 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- overweight (BMI 25-39.9 kg/m2) or waist circumference ≥ 80 cm (women) and ≥94 cm (men)
- fasting insulin over 60 pmol/L or fasting glucose 5.6 - 6.9 mmol/L
- at least one of the following criteria: Tg ≥ 1.7 mmol/L; blood pressure ≥ 130/85 mmHg; HDL < 0,9 mmol/L; hsCRP 1-10 mg/L
- non-smoking
- eating fruits and vegetables less then 5 portions/day
Who cannot join
- chronic disease
- taking drugs or natural health products that could affect glucose or lipid metabolism
- taking anti-inflammatory, antiacids
- taking pre or probiotics
- inflammatory bowel disease
- antibiotics in the past 3 months
- allergy or intolerance to cranberries or agaves
- Major surgery in the past 3 months
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of nutrition and functional foods, Laval University
Québec, Quebec, G1V 0A6
About this study
Official title: Prebiotic Supplementation and Metabolic Endotoxemia and Modulation of the Gut Microbiota: Double-blind and Randomized Parallel Clinical Study of the Efficacy and Synergistical Effect of Cranberry Polyphenols and Inulin From Agaves
The growing prevalence of obesity and type 2 diabetes (T2D) is a major public health problem. Recent studies have clearly established that the gut microbiota plays a key role in the investigator's propensity to develop obesity and associated metabolic health disorders. The gut microbiota compositions plays a decisive role in glucose metabolism and the chronic inflammatory state associated with insulin resistance. Consuming prebiotic rich diet, including polyphenol and inulin rich food could help modulate favorably the gut microbiota which could lead to a reduction of endotoxemia and beneficial metabolic health effects.
Read the detailed description
It is now recognized that overweight individuals have altered microbiota which could lead to intestinal barrier defects and chronic inflammation disorders. Polyphenols such as Proanthocyanidins may modulate the gut microbiota thereby providing beneficial effects on metabolic health. Inulin is a well known prebiotic that could stimulate growth of favorable bacteria in the gut.
The overall goal is to determine the efficacy and synergy of a supplement of polyphenols from cranberry extract with or without a supplement of inulin from agaves to reduce chronic inflammation and endotoxemia and to improve glucose metabolism and insulin sensitivity by modulating microbiota of overweight human subjects with metabolic syndrome symptoms.
- Being tested
- Cranberry, Agaves, Placebo
- Medical subject headings
- Endotoxemia, Metabolic Syndrome, Glucose Metabolism Disorders, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CranberryDietary supplement
Supplementation of polyphenols from cranberry extract
AgavesDietary supplement
Supplementation of inulin from Agaves powder
PlaceboDietary supplement
Supplementation with placebo
| Study group | Role | What they receive |
|---|---|---|
| Cranberry and Agaves | Experimental | Cranberry extract (2 capsules) + Agaves powder (1 single-dose packet) Receives: Dietary Supplement: Cranberry; Dietary Supplement: Agaves |
| Cranberry and placebo | Experimental | Cranberry extract (2 capsules) + Placebo powder (1 single-dose packet) Receives: Dietary Supplement: Cranberry; Dietary Supplement: Placebo |
| Placebo and Agaves | Experimental | Placebo (2 capsules) + Agaves powder (1 single-dose packet) Receives: Dietary Supplement: Agaves; Dietary Supplement: Placebo |
| Placebo and placebo | Placebo comparator | Placebo (2 capsules) + Placebo powder (1 single-dose packet) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma
effect of the supplements on variation in plasma concentration of LPS and LBP
Measured: At the beginning and the end of treatment (10 weeks)
Secondary outcomes (6)
Change in intestinal permeability: Measure concentration of zonulin in plasma
effect of the supplements on plasma concentration of zonulin
Measured: At the beginning and the end of treatment (10 weeks)
Change in inflammation state of the tissue: Measure concentration of calprotectin and lactoferrin in feces
effect of the supplements on fecal calprotectin and lactoferrin
Measured: At the beginning and the end of treatment (10 weeks)
Change in systemic inflammation: Measure concentration of inflammation biomarkers in the serum
effect of the supplements on chronic inflammation (serum concentration of hsCRP, Il-6, TNF-alpha, IL-1 beta, IL-23)
Measured: At the beginning and the end of treatment (10 weeks)
Change in glucose serum concentration
effect of the supplements on serum concentration of glucose
Measured: At the beginning and the end of treatment (10 weeks)
Change in insulin and C-peptide serum concentration
effect of the supplements on serum concentration of insulin and C-peptide
Measured: At the beginning and the end of treatment (10 weeks)
Change in microbiota diversity: growth of Akkermancia muciniphila, Lactobacillus, Prevotella, Bifdobacterium and inhibition of Clostridium perfringens, C. difficile, Bacteroides spp.)
Global variation of the fecal microbiota and gut microbiota profiling
Measured: At the beginning and the end of treatment (10 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 2019
- Study start5 Nov 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndotoxemiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Agriculture, Fisheries and Food, Quebec, Ministry of economic development, innovation and export trade, Quebec, Diana Food, Symrise, Atrium Innovations, NutriAgaves, Mexico, Société des Produits Nestlé (SPN)
- Responsible party
- Principal investigator, Helene Jacques, Laval University
- Investigators
- Hélène Jacques, PhD, Principal investigator, Institute of nutrition and functional foods, Laval UniversityYves Desjardins, PhD, Study director, Institute of nutrition and functional foods, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800277
- Sponsor's protocol ID
- GASTRO-Phenulin (2016-317)
- Acronym
- Phenulin
- Status last verified
- Mar 2023
- First submitted
- 6 Dec 2018
- Last updated
- 21 Mar 2023
- 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 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prebiotic Supplementation and Metabolic Endotoxemia and Modulation of the Gut Microbiota: Double-blind and Randomized Parallel Clinical Study of the Efficacy and Synergistical Effect of Cranberry Polyphenols and Inulin From Agaves
- ClinicalTrials.gov ID
- NCT03800277
- Acronym / sponsor ID
- Phenulin / GASTRO-Phenulin (2016-317)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Ministry of Agriculture, Fisheries and Food, Quebec, Ministry of economic development, innovation and export trade, Quebec, Diana Food, Symrise, Atrium Innovations, NutriAgaves, Mexico, Société des Produits Nestlé (SPN)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Jan 2019 (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.
The growing prevalence of obesity and type 2 diabetes (T2D) is a major public health problem. Recent studies have clearly established that the gut microbiota plays a key role in the investigator's propensity to develop obesity and associated metabolic health disorders. The gut microbiota compositions plays a decisive role in glucose metabolism and the chronic inflammatory state associated with insulin resistance. Consuming prebiotic rich diet, including polyphenol and inulin rich food could help modulate favorably the gut microbiota which could lead to a reduction of endotoxemia and beneficial metabolic health effects.
Detailed description
It is now recognized that overweight individuals have altered microbiota which could lead to intestinal barrier defects and chronic inflammation disorders. Polyphenols such as Proanthocyanidins may modulate the gut microbiota thereby providing beneficial effects on metabolic health. Inulin is a well known prebiotic that could stimulate growth of favorable bacteria in the gut.
The overall goal is to determine the efficacy and synergy of a supplement of polyphenols from cranberry extract with or without a supplement of inulin from agaves to reduce chronic inflammation and endotoxemia and to improve glucose metabolism and insulin sensitivity by modulating microbiota of overweight human subjects with metabolic syndrome symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cranberry and Agaves | Experimental | Dietary Supplement: Cranberry, Dietary Supplement: AgavesCranberry extract (2 capsules) + Agaves powder (1 single-dose packet) |
| Cranberry and placebo | Experimental | Dietary Supplement: Cranberry, Dietary Supplement: PlaceboCranberry extract (2 capsules) + Placebo powder (1 single-dose packet) |
| Placebo and Agaves | Experimental | Dietary Supplement: Agaves, Dietary Supplement: PlaceboPlacebo (2 capsules) + Agaves powder (1 single-dose packet) |
| Placebo and placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (2 capsules) + Placebo powder (1 single-dose packet) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- overweight (BMI 25-39.9 kg/m2) or waist circumference ≥ 80 cm (women) and ≥94 cm (men)
- fasting insulin over 60 pmol/L or fasting glucose 5.6 - 6.9 mmol/L
- at least one of the following criteria: Tg ≥ 1.7 mmol/L; blood pressure ≥ 130/85 mmHg; HDL < 0,9 mmol/L; hsCRP 1-10 mg/L
- non-smoking
- eating fruits and vegetables less then 5 portions/day
Key exclusion criteria (8 listed)
- chronic disease
- taking drugs or natural health products that could affect glucose or lipid metabolism
- taking anti-inflammatory, antiacids
- taking pre or probiotics
- inflammatory bowel disease
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 |
|---|---|---|
| CranberrySupplementation of polyphenols from cranberry extract | Dietary supplement | Cranberry and Agaves, Cranberry and placebo |
| AgavesSupplementation of inulin from Agaves powder | Dietary supplement | Cranberry and Agaves, Placebo and Agaves |
| PlaceboSupplementation with placebo | Dietary supplement | Cranberry and placebo, Placebo and Agaves, Placebo and placebo |
Primary outcome
Change in metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma
Time frame: At the beginning and the end of treatment (10 weeks)
effect of the supplements on variation in plasma concentration of LPS and LBP
6 secondary outcomes
Change in intestinal permeability: Measure concentration of zonulin in plasma
Time frame: At the beginning and the end of treatment (10 weeks)
Change in inflammation state of the tissue: Measure concentration of calprotectin and lactoferrin in feces
Time frame: At the beginning and the end of treatment (10 weeks)
Change in systemic inflammation: Measure concentration of inflammation biomarkers in the serum
Time frame: At the beginning and the end of treatment (10 weeks)
Change in glucose serum concentration
Time frame: At the beginning and the end of treatment (10 weeks)
Change in insulin and C-peptide serum concentration
Time frame: At the beginning and the end of treatment (10 weeks)
Change in microbiota diversity: growth of Akkermancia muciniphila, Lactobacillus, Prevotella, Bifdobacterium and inhibition of Clostridium perfringens, C. difficile, Bacteroides spp.)
Time frame: At the beginning and the end of treatment (10 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 21 Mar 2023.
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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.
Hélène Jacques, PhD principal investigator
Institute of nutrition and functional foods, Laval University
Yves Desjardins, PhD study director
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 and Agaves in people with Endotoxemia and Metabolic Syndrome, 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 5 inclusion and 8 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 21 Mar 2023. 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 metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma (time frame: At the beginning and the end of treatment (10 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 21 Mar 2023.