NCT06680219

Evaluation of the the Efficacy of a Digestive Health Supplement in Healthy Subjects

A Single Centre, Double Blind, Placebo Controlled, Randomised Clinical Study Design in Healthy Subjects to Evaluate the Efficacy of a Digestive Health Supplement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Pharmanex · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the efficacy of a digestive health supplement via waist circumference measurements, daily bowel habit and symptom logs, and self-perception questionnaires (SPQ) over 4 weeks. To test for the following claims: * Reduction of bloating after only one use. * SPQ claims - to be determined by the sponsor. * Improvement to a range of upper and lower gastrointestinal symptoms (heartburn, belching, bloating, nausea, vomiting, flatulence, intestinal cramps, urge to defecate, loose stool, and diarrhea) * Clinically proven formulation * Supports relief of bloating discomfort * Supports quick and effective reduction in bloating related to food intake * Study shows X% severity reduction in abdominal bloating * Helps support a reduction in days experiencing bloating * Supports a reduction in abdominal discomfort * X% of participants reported a reduction in bloating during the study * Supports a reduction in waist circumference, related to bloating Please note that it is the responsibility of the sponsor to determine the testing and study designs required for submission to entities such as the Home Shopping Network, QVC, etc.

Detailed description

Title: A single centre, double blind, placebo controlled, randomised clinical study design in healthy subjects to evaluate the efficacy of a digestive health supplement. Study design: Single centre, placebo controlled, randomised 4-week home use study. Test article: 1. ACTIVE - Nu Biome (Formula #: 95001996; Batch #: EV24931) 2. PLACEBO - Crystal Light Raspberry Lemonade Duration of study: Approximately 4 weeks Number of subjects: Enough subjects will be recruited onto the study to finish with 50 subjects overall across two (2) study groups: Group 1: at least 20 subjects in the placebo group. Group 2: at least 30 subjects in the active test article group. Types of subjects: Healthy male and female subjects aged 20 - 60 years old including a range of ethnicities. Subjects must routinely experience gastrointestinal discomfort, specifically bloating. Observations: Assessments for the randomised home use 4-week study consist of the following: * Daily bowel habits log. * Daily abdominal discomfort logs covering upper and lower gastrointestinal (GI) issues. * Digestion-associated Quality of Life Questionnaire (DQLQ) at baseline, week 2, and week 4. * Self-perception questionnaire for bloating at the 1st study visit (baseline and after 1 hour), at the 2nd study visit after 2 weeks of home use, and at the 3rd study visit after 4 weeks of home use (baseline and after 1 hour). * Waist circumference measurements at the 1 st study visit (baseline and after 1 hour), at the 2nd study visit after 2 weeks of home use, and at the 3rd study visit after 4 weeks of home use (baseline and after 1 hour). * Digital Photography of 20 subjects (10 from Group 1, 10 from Group 2) at the 1st study visit (baseline and after 1 hour), and at the 3rd study visit after 4 weeks of home use (baseline and after 1 hour).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Crystal Light Raspberry Lemonade: Mix 3 scoops of powder (with scoop provided) with 8-12 oz of water. Enjoy once daily (8-12 oz of water is approximately 236-354 mL of water).
DIETARY_SUPPLEMENT	Active comparator	ACTIVE - Nu Biome (Formula #: 95001996; Batch #: EV24931): Mix 3 scoops of powder (with scoop provided) with 8-12 oz of water. Enjoy once daily. (8-12 oz of water is approximately 236-354 mL of water).

Timeline

• Start date: 2024-02-21
• Primary completion: 2024-06-30
• Completion: 2024-08-31
• First posted: 2024-11-08
• Last updated: 2024-11-08

Locations

1 site across 1 country: United Kingdom