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Completed

NCT Number: NCT03800277

Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of nutrition and functional foods, Laval University

Québec, Quebec, G1V 0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cranberry

Dietary Supplement

Supplementation of polyphenols from cranberry extract

Agaves

Dietary Supplement

Supplementation of inulin from Agaves powder

Placebo

Dietary Supplement

Supplementation with placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in intestinal permeability: Measure concentration of zonulin in plasma

    Time frame: At the beginning and the end of treatment (10 weeks)

    effect of the supplements on plasma concentration of zonulin

  2. 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)

    effect of the supplements on fecal calprotectin and lactoferrin

  3. Change in systemic inflammation: Measure concentration of inflammation biomarkers in the serum

    Time frame: At the beginning and the end of treatment (10 weeks)

    effect of the supplements on chronic inflammation (serum concentration of hsCRP, Il-6, TNF-alpha, IL-1 beta, IL-23)

  4. Change in glucose serum concentration

    Time frame: At the beginning and the end of treatment (10 weeks)

    effect of the supplements on serum concentration of glucose

  5. Change in insulin and C-peptide serum concentration

    Time frame: At the beginning and the end of treatment (10 weeks)

    effect of the supplements on serum concentration of insulin and C-peptide

  6. 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)

    Global variation of the fecal microbiota and gut microbiota profiling

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • 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)

Registry information

Official study 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

Acronym: Phenulin

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jan 11, 2019
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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