A randomized, double-blind, placebo-controlled clinical trial of nutraceutical formulation in improving gut health in adults.

Life Synergy1 site in 1 country90 target enrollmentStarted: November 18, 2024Last updated: November 6, 2024

Overview

Brief Summary

Gut health plays a critical role in overall well-being, influencing digestion, immunity, metabolism, and even mental health. However, imbalances in gut microbiota, inflammation, and digestive disorders are common, and current treatments may be insufficient or have unwanted side effects. Nutraceuticals, which consist of bioactive compounds from food sources, have shown potential to improve gut health by promoting a balanced gut microbiome, enhancing nutrient absorption, and reducing gastrointestinal discomfort. Preclinical and limited clinical studies have suggested that specific formulations of nutraceuticals may offer protective and therapeutic benefits to gut health.

By using a placebo control and a double-blind design, this trial aims to provide robust data on the true efficacy of these formulations. If successful, these nutraceuticals could offer a natural, side-effect-free alternative for individuals seeking to improve gut health, with broader implications for managing gut-related conditions and improving general wellness.

Study Design

Study Type: Interventional
Allocation: Randomized
Masking: Participant and Investigator Blinded

Eligibility Criteria

Ages: 20.00 Year(s) to 50.00 Year(s) (—)
Sex: All

Inclusion Criteria

•1.Males and females aged 20-50years, with an equal gender distribution (both inclusive); 2.Participants must report one or more gut health-related symptoms, indicated by a GSRS score of 3 to 5 or a BSFS score of 1 to
•Eligible symptoms include:â€¢Bloatingâ€¢Abdominal discomfort or painâ€¢Infrequent bowel movements fewer than three defecations per weekâ€¢Hard or lumpy stools types 1 to 3 on the Bristol Stool Form Scaleâ€¢Sensation of incomplete evacuation during defecation.3.Participants in whom loose stools are rarely present without the use of laxatives;4.Participants on stable medication for the past three months with no worsening of symptoms or hospitalization are eligible, or may be enrolled at the discretion of the investigator;5.Participants should agree to undergo Liver Function Tests and C-reactive protein assessments;6.Willingness to undergo baseline and follow-up assessments of gut health using the GSRS;7.Participants providing voluntary, written informed consent to participate in the study.

Exclusion Criteria

•1.Participants with a diagnosis of colonic inertia; 2.Participants with a history of surgical interventions within the last six months; 3.History of anorectal surgery; 4.Participants diagnosed with functional gastrointestinal disorders, including Functional Constipation, Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), or chronic diarrhea; 5.Participants with structural abnormalities such as rectal prolapse, rectocele, or anorectal stricture; 6.Participants with untreated or uncontrolled systemic conditions, including HIV, diabetes mellitus, or tuberculosis; 7.Participants with renal or liver dysfunction; 8.Participants with neurological disorders, such as Parkinsons disease or multiple sclerosis; 9.A medical history of hypothyroidism, Grade 2 obesity, morbid obesity, or constipation associated with premenopausal or postmenopausal status; 10.Participants currently using laxatives, antacids, proton pump inhibitors, antibiotics, or other probiotic products; 11.Participants using herbal supplements, dietary fiber, or phytonutrient supplements; 12.Participants will be excluded if they have initiated new micronutrient supplements e.g. iron, zinc within the past 14 days; 13.Participants who have undergone colonic cleansing in the last three months; 14.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study; 15.Participants with a history of substance abuse or heavy use of alcohol and drugs or tobacco use, where participants smoke more than 1 or 2 pack per day; 16.Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.