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

Laval University

Status: Completed

Conditions: Glucose Metabolism Disorders; Insulin Resistance; Endotoxemia; Metabolic Syndrome

Treatments: Dietary Supplement: Cranberry; Dietary Supplement: Agaves; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03800277

GASTRO-Phenulin (2016-317)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 4 patient groups, including a placebo group

Cranberry and Agaves

Experimental group

Description:

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

Treatment:

Dietary Supplement: Agaves

Dietary Supplement: Cranberry

Cranberry and placebo

Experimental group

Description:

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

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Cranberry

Placebo and Agaves

Experimental group

Description:

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

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Agaves

Placebo and placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo