NCT03754504

Brief Summary

It is of major importance to refine prevention strategies in order to alleviate inflammation, insulin resistance and metabolic syndrome and it appear that improving gut health and microbiota represent a promising strategy. Cranberry-enriched diets may help prevent metabolic syndrome and its associated chronic diseases by a protective effect of gut health and microbiota. It is therefore highly relevant to test the hypothesis that a whole cranberry powder supplements (which include a mixture of polyphenols, free and fiber-associated proanthocyanidins, and fruits fibers) is associated with changes on the gut health and microbiota playing a major role in alleviating inflammation and obesity-associated metabolic disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

November 19, 2018

Last Update Submit

March 26, 2020

Conditions

OverweightInsulin ResistanceMicrobiotaEndotoxemiaMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in Gut Microbiota Diversity

    Global variation of the fecal microbiota

    At the beginning and the end of each treatment (4 weeks each)

Secondary Outcomes (8)

  • Change in Endotoxemia

    At the beginning and the end of each treatment (4 weeks each)

  • Change in Intestinal permeability

    At the beginning and the end of each treatment (4 weeks each)

  • Change in Inflammation state of the tissue

    At the beginning and the end of each treatment (4 weeks each)

  • Change in Short chain fatty acids in the feces

    At the beginning and the end of each treatment (4 weeks each)

  • Change in Gut health and stool consistency

    At the beginning and the end of each treatment (4 weeks each)

  • +3 more secondary outcomes

Study Arms (2)

Cranberry

EXPERIMENTAL

Whole Cranberry Powder Supplements

Dietary Supplement: Cranberry powder

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Cranberry powderDIETARY_SUPPLEMENT

3 capsules /day of whole cranberry powder (500mg/each)

Cranberry
PlaceboDIETARY_SUPPLEMENT

3 capsules/day of a placebo comparator

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • overweight
  • fasting insulin \> 42 pmol/L
  • non smoking
  • Stable weight in the past 3 months

You may not qualify if:

  • chronic diseases
  • Taking drugs that could affect glucose or lipid metabolism
  • Taking anti-inflammatory, immunosuppressant or anticoagulant drugs
  • Inflammatory bowel disease
  • vegetarians, vegan or following any restrictive dietary pattern or if they are big consumers of berries (\>1 portion/day)
  • taking pre- and probiotics
  • antibiotics in the past 3 months or change in their regular medication
  • Major surgery in the past 3 months
  • taste aversion for cranberries or cranberry allergy or allergies to other ingredients used in the placebo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut sur la nutrition et les aliments fonctionnels

Québec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

OverweightInsulin ResistanceEndotoxemiaMetabolic Syndrome

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBacteremiaSepsisInfectionsToxemiaSystemic Inflammatory Response SyndromeInflammationPathologic Processes

Study Officials

  • André Marette, Ph.D

    Institute of nutrition and functional foods, Laval University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 27, 2018

Study Start

October 15, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

March 30, 2020

Record last verified: 2020-03

Locations

CA(1)