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

NCT06680219 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-11-08

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

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).

Sponsors & Collaborators

  • Pharmanex

    lead INDUSTRY

Principal Investigators

  • Barrie Drewitt · PCR Corp

  • Jamie Jarvis · PCR Corp

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-21
Primary Completion
2024-06-30
Completion
2024-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06680219 on ClinicalTrials.gov