Evaluation of the the Efficacy of a Digestive Health Supplement in Healthy Subjects
- Conditions
- Healthy Subjects
- Registration Number
- NCT06680219
- Lead Sponsor
- Pharmanex
- Brief 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Daily bowel habits log 30 days Subjects in both arms will be asked to record their daily bowel habits in a diary using Bristol stool chart as a reference.
Daily abdominal discomfort assessment 30 days Daily abdominal discomfort assessment will be recorded by subjects in a diary using Bristol Stool Chart as a reference on a scale of 0 to 10, with 0 (no discomfort) to 10 (worst discomfort).
Digestion-associated Quality of Life Questionnaire (DQLQ) assessment 30 days Digestion-associated Quality of Life Questionnaire (DQLQ) will be assessed on a scale of 0% to 100% at baseline, week 2, and week 4, with 0% indicating no effect (never) on digestion-associated quality of life to 90%-100% (always effecting digestion-associated Quality of Life)
Self-perception questionnaire for assessment of bloating 30 days Assessment of bloating using a self-perception questionnaire on a scale of None (no bloating) to very severe (severe bloating) will be conducted 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PCR Corp
🇬🇧Chelmsford, Essex, United Kingdom