Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health (Phenulin)
Primary Purpose
Endotoxemia, Metabolic Syndrome, Glucose Metabolism Disorders
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cranberry
Agaves
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Endotoxemia
Eligibility Criteria
Inclusion Criteria:
- overweight (BMI 25-39.9 kg/m2)
- fasting insulin over 60 pmol/L or fasting glucose 5.6 - 6.9 mmol/L
- hsCRP 1-10 mg/L
- at least one of the following criteria: waist circumference ≥ 80 cm (women) and ≥94 cm (men); Tg ≥ 1.7 mmol/L; blood pressure ≥ 130/85 mmHg; HDL < 0,9 mmol/L
- non-smoking
- eating fruits and vegetables less then 5 portions/day
Exclusion Criteria:
- 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
Sites / Locations
- Institute of nutrition and functional foods, Laval University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Cranberry and Agaves
Cranberry and placebo
Placebo and Agaves
Placebo and placebo
Arm Description
Cranberry extract (2 capsules) + Agaves powder (1 single-dose packet)
Cranberry extract (2 capsules) + Placebo powder (1 single-dose packet)
Placebo (2 capsules) + Agaves powder (1 single-dose packet)
Placebo (2 capsules) + Placebo powder (1 single-dose packet)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in intestinal permeability: Measure concentration of zonulin in plasma
effect of the supplements on plasma concentration of zonulin
Change in inflammation state of the tissue: Measure concentration of calprotectin and lactoferrin in feces
effect of the supplements on fecal calprotectin and lactoferrin
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)
Change in glucose serum concentration
effect of the supplements on serum concentration of glucose
Change in insulin and C-peptide serum concentration
effect of the supplements on serum concentration of insulin and C-peptide
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
Full Information
NCT ID
NCT03800277
First Posted
December 6, 2018
Last Updated
March 17, 2023
Sponsor
Laval University
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)
1. Study Identification
Unique Protocol Identification Number
NCT03800277
Brief Title
Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health
Acronym
Phenulin
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
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)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endotoxemia, Metabolic Syndrome, Glucose Metabolism Disorders, Insulin Resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cranberry and Agaves
Arm Type
Experimental
Arm Description
Cranberry extract (2 capsules) + Agaves powder (1 single-dose packet)
Arm Title
Cranberry and placebo
Arm Type
Experimental
Arm Description
Cranberry extract (2 capsules) + Placebo powder (1 single-dose packet)
Arm Title
Placebo and Agaves
Arm Type
Experimental
Arm Description
Placebo (2 capsules) + Agaves powder (1 single-dose packet)
Arm Title
Placebo and placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (2 capsules) + Placebo powder (1 single-dose packet)
Intervention Type
Dietary Supplement
Intervention Name(s)
Cranberry
Intervention Description
Supplementation of polyphenols from cranberry extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Agaves
Intervention Description
Supplementation of inulin from Agaves powder
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Supplementation with placebo
Primary Outcome Measure Information:
Title
Change in metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma
Description
effect of the supplements on variation in plasma concentration of LPS and LBP
Time Frame
At the beginning and the end of treatment (10 weeks)
Secondary Outcome Measure Information:
Title
Change in intestinal permeability: Measure concentration of zonulin in plasma
Description
effect of the supplements on plasma concentration of zonulin
Time Frame
At the beginning and the end of treatment (10 weeks)
Title
Change in inflammation state of the tissue: Measure concentration of calprotectin and lactoferrin in feces
Description
effect of the supplements on fecal calprotectin and lactoferrin
Time Frame
At the beginning and the end of treatment (10 weeks)
Title
Change in systemic inflammation: Measure concentration of inflammation biomarkers in the serum
Description
effect of the supplements on chronic inflammation (serum concentration of hsCRP, Il-6, TNF-alpha, IL-1 beta, IL-23)
Time Frame
At the beginning and the end of treatment (10 weeks)
Title
Change in glucose serum concentration
Description
effect of the supplements on serum concentration of glucose
Time Frame
At the beginning and the end of treatment (10 weeks)
Title
Change in insulin and C-peptide serum concentration
Description
effect of the supplements on serum concentration of insulin and C-peptide
Time Frame
At the beginning and the end of treatment (10 weeks)
Title
Change in microbiota diversity: growth of Akkermancia muciniphila, Lactobacillus, Prevotella, Bifdobacterium and inhibition of Clostridium perfringens, C. difficile, Bacteroides spp.)
Description
Global variation of the fecal microbiota and gut microbiota profiling
Time Frame
At the beginning and the end of treatment (10 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène Jacques, PhD
Organizational Affiliation
Institute of nutrition and functional foods, Laval University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yves Desjardins, PhD
Organizational Affiliation
Institute of nutrition and functional foods, Laval University
Official's Role
Study Director
Facility Information:
Facility Name
Institute of nutrition and functional foods, Laval University
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health
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