Clinical trial NCT03800277: Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health
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
Overall status: COMPLETED
Phase: NA
Conditions: Endotoxemia
Metabolic Syndrome
Glucose Metabolism Disorders
Insulin Resistance
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Ministry of Agriculture, Fisheries and Food, Quebec
name: Ministry of economic development, innovation and export trade, Quebec
name: Diana Food, Symrise
name: Atrium Innovations
name: NutriAgaves, Mexico
name: Société des Produits Nestlé (SPN)
First posted: 2019-01-11
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma
timeFrame: At the beginning and the end of treatment (10 weeks)
Secondary outcomes:
measure: Change in intestinal permeability: Measure concentration of zonulin in plasma
timeFrame: At the beginning and the end of treatment (10 weeks)
measure: Change in inflammation state of the tissue: Measure concentration of calprotectin and lactoferrin in feces
timeFrame: At the beginning and the end of treatment (10 weeks)
measure: Change in systemic inflammation: Measure concentration of inflammation biomarkers in the serum
timeFrame: At the beginning and the end of treatment (10 weeks)
measure: Change in glucose serum concentration
timeFrame: At the beginning and the end of treatment (10 weeks)
measure: Change in insulin and C-peptide serum concentration
timeFrame: At the beginning and the end of treatment (10 weeks)
measure: Change in microbiota diversity: growth of Akkermancia muciniphila, Lactobacillus, Prevotella, Bifdobacterium and inhibition of Clostridium perfringens, C. difficile, Bacteroides spp.)
timeFrame: At the beginning and the end of treatment (10 weeks)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institute of nutrition and functional foods, Laval University
state: Quebec
Study officials:
affiliation: Institute of nutrition and functional foods, Laval University
name: Hélène Jacques, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of nutrition and functional foods, Laval University
name: Yves Desjardins, PhD
role: STUDY_DIRECTOR
References: