The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals With Excessive Body Weight

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-70
SponsorChr Hansen - part of Novonesis

About this trial

The study is a single-center, randomized, double-blind, placebo-controlled study in middle-aged to elderly adults with excessive body weight. The study includes an 8-week intervention period followed by a 2-week follow-up period. The study will evaluate the effect of a synbiotic consisting of two probiotic strains and a prebiotic.

The aim is to investigate the effect of the synbiotic on modulating the gut microbiota and improving markers of gastrointestinal permeability and integrity and gastrointestinal discomfort.

Eligibility criteria

Qualifiers

Be able to give informed consent.

Be between 50 to 70 years of age (inclusive).

BMI ranging from 25.0 and 35.0 kg/m²

Willing to maintain current level of physical activity and diet during the participation in the study.

Disqualifiers

Has a history of drug and/or alcohol abuse.

Has food allergies, or other issues with foods, that would preclude intake of the study products.

Smoking, chewable tobacco and/or vaping and/or use of other nicotine products.

diagnosis of GI disease (e.g. gastric or duodenal ulcers, inflammatory bowel disease, colon cancer) or irritable bowel syndrome (IBS)

Trial design

Treatments tested in this trial

  • Synbiotic
  • Placebo

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators