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Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health (Phenulin)

Primary Purpose

Endotoxemia, Metabolic Syndrome, Glucose Metabolism Disorders

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Cranberry

Agaves

Placebo

About this trial

This is an interventional prevention trial for Endotoxemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

overweight (BMI 25-39.9 kg/m2)
fasting insulin over 60 pmol/L or fasting glucose 5.6 - 6.9 mmol/L
hsCRP 1-10 mg/L
at least one of the following criteria: waist circumference ≥ 80 cm (women) and ≥94 cm (men); Tg ≥ 1.7 mmol/L; blood pressure ≥ 130/85 mmHg; HDL < 0,9 mmol/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

Sites / Locations

Institute of nutrition and functional foods, Laval University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Cranberry and Agaves

Cranberry and placebo

Placebo and Agaves

Placebo and placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in intestinal permeability: Measure concentration of zonulin in plasma

effect of the supplements on plasma concentration of zonulin

Change in inflammation state of the tissue: Measure concentration of calprotectin and lactoferrin in feces

effect of the supplements on fecal calprotectin and lactoferrin

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)

Change in glucose serum concentration

effect of the supplements on serum concentration of glucose

Change in insulin and C-peptide serum concentration

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

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

Full Information

NCT ID

NCT03800277

First Posted

December 6, 2018

Last Updated

March 17, 2023

Sponsor

Laval University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03800277

Brief Title

Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

November 5, 2018 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Laval University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endotoxemia, Metabolic Syndrome, Glucose Metabolism Disorders, Insulin Resistance

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cranberry and Agaves

Arm Type

Experimental

Arm Description

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

Arm Title

Cranberry and placebo

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo and Agaves

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo and placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Cranberry

Intervention Description

Supplementation of polyphenols from cranberry extract

Intervention Type

Dietary Supplement

Intervention Name(s)

Agaves

Intervention Description

Supplementation of inulin from Agaves powder

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Supplementation with placebo

Primary Outcome Measure Information:

Title

Change in metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma

Description

effect of the supplements on variation in plasma concentration of LPS and LBP

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in intestinal permeability: Measure concentration of zonulin in plasma

Description

effect of the supplements on plasma concentration of zonulin

Time Frame

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

Title

Change in inflammation state of the tissue: Measure concentration of calprotectin and lactoferrin in feces

Description

effect of the supplements on fecal calprotectin and lactoferrin

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

Change in glucose serum concentration

Description

effect of the supplements on serum concentration of glucose

Time Frame

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

Title

Change in insulin and C-peptide serum concentration

Description

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

Time Frame

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

Title

Change in microbiota diversity: growth of Akkermancia muciniphila, Lactobacillus, Prevotella, Bifdobacterium and inhibition of Clostridium perfringens, C. difficile, Bacteroides spp.)

Description

Global variation of the fecal microbiota and gut microbiota profiling

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hélène Jacques, PhD

Organizational Affiliation

Institute of nutrition and functional foods, Laval University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yves Desjardins, PhD

Organizational Affiliation

Institute of nutrition and functional foods, Laval University

Official's Role

Study Director

Facility Information:

Facility Name

Institute of nutrition and functional foods, Laval University

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1V 0A6

Country

Canada

12. IPD Sharing Statement

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Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health

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