Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health
NCT ID: NCT03800277
Last Updated: 2023-03-21
Study Results
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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COMPLETED
NA
122 participants
INTERVENTIONAL
2018-11-05
2021-12-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Cranberry and Agaves
Cranberry extract (2 capsules) + Agaves powder (1 single-dose packet)
Cranberry
Supplementation of polyphenols from cranberry extract
Agaves
Supplementation of inulin from Agaves powder
Cranberry and placebo
Cranberry extract (2 capsules) + Placebo powder (1 single-dose packet)
Cranberry
Supplementation of polyphenols from cranberry extract
Placebo
Supplementation with placebo
Placebo and Agaves
Placebo (2 capsules) + Agaves powder (1 single-dose packet)
Agaves
Supplementation of inulin from Agaves powder
Placebo
Supplementation with placebo
Placebo and placebo
Placebo (2 capsules) + Placebo powder (1 single-dose packet)
Placebo
Supplementation with placebo
Interventions
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Cranberry
Supplementation of polyphenols from cranberry extract
Agaves
Supplementation of inulin from Agaves powder
Placebo
Supplementation with placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Ministry of Agriculture, Fisheries and Food, Quebec
OTHER_GOV
Ministry of economic development, innovation and export trade, Quebec
UNKNOWN
Diana Food, Symrise
UNKNOWN
Atrium Innovations
INDUSTRY
NutriAgaves, Mexico
UNKNOWN
Société des Produits Nestlé (SPN)
INDUSTRY
Laval University
OTHER
Responsible Party
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Helene Jacques
Professor
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
Countries
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Other Identifiers
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GASTRO-Phenulin (2016-317)
Identifier Type: -
Identifier Source: org_study_id
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