Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health

NCT ID: NCT03800277

Last Updated: 2023-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Endotoxemia Metabolic Syndrome Glucose Metabolism Disorders Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cranberry and Agaves

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

Group Type EXPERIMENTAL

Cranberry

Intervention Type DIETARY_SUPPLEMENT

Supplementation of polyphenols from cranberry extract

Agaves

Intervention Type DIETARY_SUPPLEMENT

Supplementation of inulin from Agaves powder

Cranberry and placebo

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

Group Type EXPERIMENTAL

Cranberry

Intervention Type DIETARY_SUPPLEMENT

Supplementation of polyphenols from cranberry extract

Placebo

Intervention Type DIETARY_SUPPLEMENT

Supplementation with placebo

Placebo and Agaves

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

Group Type EXPERIMENTAL

Agaves

Intervention Type DIETARY_SUPPLEMENT

Supplementation of inulin from Agaves powder

Placebo

Intervention Type DIETARY_SUPPLEMENT

Supplementation with placebo

Placebo and placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Supplementation with placebo

Interventions

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Cranberry

Supplementation of polyphenols from cranberry extract

Intervention Type DIETARY_SUPPLEMENT

Agaves

Supplementation of inulin from Agaves powder

Intervention Type DIETARY_SUPPLEMENT

Placebo

Supplementation with placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Agriculture, Fisheries and Food, Quebec

OTHER_GOV

Sponsor Role collaborator

Ministry of economic development, innovation and export trade, Quebec

UNKNOWN

Sponsor Role collaborator

Diana Food, Symrise

UNKNOWN

Sponsor Role collaborator

Atrium Innovations

INDUSTRY

Sponsor Role collaborator

NutriAgaves, Mexico

UNKNOWN

Sponsor Role collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

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Helene Jacques

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hélène Jacques, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of nutrition and functional foods, Laval University

Yves Desjardins, PhD

Role: STUDY_DIRECTOR

Institute of nutrition and functional foods, Laval University

Locations

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Institute of nutrition and functional foods, Laval University

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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GASTRO-Phenulin (2016-317)

Identifier Type: -

Identifier Source: org_study_id

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