Trial | NCT03800277  Report issue

Title

Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health
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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    122
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.
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.
Study Started
Nov 05
2018
Primary Completion
Dec 31
2020
Study Completion
Dec 31
2021
Last Update
Mar 21
2023

Dietary Supplement Cranberry

Supplementation of polyphenols from cranberry extract

Dietary Supplement Agaves

Supplementation of inulin from Agaves powder

Dietary Supplement Placebo

Supplementation with placebo

Cranberry and Agaves Experimental

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

Cranberry and placebo Experimental

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

Placebo and Agaves Experimental

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

Placebo and placebo Placebo Comparator

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

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
No Results Posted