Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health

NCT03800277 | Completed

• 1 other identifier: GASTRO-Phenulin (2016-317)
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Endotoxemia; Metabolic Syndrome; Glucose Metabolism Disorders; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in intestinal permeability: Measure concentration of zonulin in plasma

  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

  At the beginning and the end of treatment (10 weeks)

• Change in systemic inflammation: Measure concentration of inflammation biomarkers in the serum

  At the beginning and the end of treatment (10 weeks)

• Change in glucose serum concentration

  At the beginning and the end of treatment (10 weeks)

• Change in insulin and C-peptide serum concentration

  At the beginning and the end of treatment (10 weeks)

Study Arms (4)

Cranberry and Agaves

EXPERIMENTAL

Cranberry extract (2 capsules) + Agaves powder (1 single-dose packet)

Dietary Supplement: Cranberry; Dietary Supplement: Agaves

Cranberry and placebo

EXPERIMENTAL

Cranberry extract (2 capsules) + Placebo powder (1 single-dose packet)

Dietary Supplement: Cranberry; Dietary Supplement: Placebo

Placebo and Agaves

EXPERIMENTAL

Placebo (2 capsules) + Agaves powder (1 single-dose packet)

Dietary Supplement: Agaves; Dietary Supplement: Placebo

Placebo and placebo

PLACEBO COMPARATOR

Placebo (2 capsules) + Placebo powder (1 single-dose packet)

Dietary Supplement: Placebo

Interventions

Cranberry DIETARY_SUPPLEMENT

Supplementation of polyphenols from cranberry extract

Cranberry and Agaves; Cranberry and placebo

Agaves DIETARY_SUPPLEMENT

Supplementation of inulin from Agaves powder

Cranberry and Agaves; Placebo and Agaves

Placebo DIETARY_SUPPLEMENT

Supplementation with placebo

Cranberry and placebo; Placebo and Agaves; Placebo and placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Institute of nutrition and functional foods, Laval University

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Endotoxemia; Metabolic Syndrome; Glucose Metabolism Disorders; Insulin Resistance

Condition Hierarchy (Ancestors)

Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hélène Jacques, PhD

  Institute of nutrition and functional foods, Laval University

  PRINCIPAL INVESTIGATOR

• Yves Desjardins, PhD

  Institute of nutrition and functional foods, Laval University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: January 11, 2019
• Study Start: November 5, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

CA (1)