Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health

Metabolic Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03800277
• Other study ID #: GASTRO-Phenulin (2016-317)
• Status: Completed
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2023
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Endotoxemia
• Glucose Metabolism Disorders
• Insulin Resistance
• Metabolic Diseases
• Metabolic Syndrome

Intervention

Dietary Supplement:
• Cranberry
Supplementation of polyphenols from cranberry extract
• Agaves
Supplementation of inulin from Agaves powder
• Placebo
Supplementation with placebo

Locations

Country	Name	City	State
Canada	Institute of nutrition and functional foods, Laval University	Québec	Quebec

Sponsors (7)

Lead Sponsor	Collaborator
Laval University	Atrium Innovations, Diana Food, Symrise, Ministry of Agriculture, Fisheries and Food, Quebec, Ministry of economic development, innovation and export trade, Quebec, NutriAgaves, Mexico, Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At the beginning and the end of treatment (10 weeks)
Secondary	Change in intestinal permeability: Measure concentration of zonulin in plasma	effect of the supplements on plasma concentration of zonulin	At the beginning and the end of treatment (10 weeks)
Secondary	Change in inflammation state of the tissue: Measure concentration of calprotectin and lactoferrin in feces	effect of the supplements on fecal calprotectin and lactoferrin	At the beginning and the end of treatment (10 weeks)
Secondary	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)	At the beginning and the end of treatment (10 weeks)
Secondary	Change in glucose serum concentration	effect of the supplements on serum concentration of glucose	At the beginning and the end of treatment (10 weeks)
Secondary	Change in insulin and C-peptide serum concentration	effect of the supplements on serum concentration of insulin and C-peptide	At the beginning and the end of treatment (10 weeks)
Secondary	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	At the beginning and the end of treatment (10 weeks)