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

NCT06680219 | Completed

• 1 other identifier: RIGSUP2C
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Nu Biome; abdominal discomfort logs; bloating

Outcome Measures

Primary Outcomes (4)

• Daily bowel habits log

  Subjects in both arms will be asked to record their daily bowel habits in a diary using Bristol stool chart as a reference.

  30 days

• Daily abdominal discomfort assessment

  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).

  30 days

• Digestion-associated Quality of Life Questionnaire (DQLQ) assessment

  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)

  30 days

• Self-perception questionnaire for assessment of bloating

  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).

  30 days

Study Arms (2)

Placebo controlled, randomised 4-week home use study

PLACEBO COMPARATOR

The sample is Crystal Light Raspberry Lemonade Placebo sample Usage instructions for all groups: 2\. 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: Placebo

Active comparator for randomised 4-week home use study

ACTIVE COMPARATOR

ACTIVE - Nu Biome (Formula #: 95001996; Batch #: EV24931) Active sample Usage instructions for all groups: 1\. 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

Interventions

Placebo DIETARY_SUPPLEMENT

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).

Placebo controlled, randomised 4-week home use study

Active comparator DIETARY_SUPPLEMENT

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).

Active comparator for randomised 4-week home use study

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects aged 20 - 60 years old including a range of ethnicities.
• Subject routinely experiences gastrointestinal discomfort, specifically bloating.
• Subject has signed a written Informed Consent.
• Willing to use the test article as instructed following the directions for usage provided by the sponsor.
• Willing to attend study visits 1 and 3 having fasted for 8 hours (only water allowed).
• Willing to consume a test meal in conjunction with the supplement on study visits 1 and 3.
• Willing to record daily logs of their bowel habits and abdominal discomfort.
• Willing to attend all study visits.
• Photography subjects: subjects undergoing clinical photography of the abdomen area are willing to wear the same clothing to visits 1 and 3 (or at least the same colour clothing).

You may not qualify if:

• Subject is pregnant, nursing, or planning to become pregnant.
• Treatment or medication containing sympathomimetics, antihistamines or corticosteroids in the seven days prior to study start.
• Known allergies or hypersensitivity to dietary supplements, similar materials, or their ingredients including, but not limited to, hazelnuts, peanuts and pomegranates (family Lythraceae).
• Subject has allergies or sensitivity (other than bloating/indigestion issues/GI discomfort) to the ingredients of the test meal.
• Insulin dependent diabetes.
• Subjects with history of any gastrointestinal surgery, gastrointestinal illness which in the opinion of the Investigator would affect the digestive and absorption processes of the body (i.e., Gastric bypass, Gastroenteritis, Irritable Bowel Syndrome, Celiac Disease).
• Medical condition that may affect study data or subject safety which in the opinion of the Investigator would compromise the safety of the subject or study results.
• History of poor cooperation, non-compliance, or unreliability.
• Investigator deems the subject an unsuitable candidate for the study.
• Subject is currently participating in another clinical trial involving dietary supplements or similar materials.
• Subject uses any prescription or over the counter (OTC) medication, vitamins, herbal products, antacids, mineral supplements and dietary supplements that target digestive issues and bloating within 4 weeks prior to the study start and through the end of study.
• Chronic use of NSAIDs (e.g., Ibuprofen, Advil), or use of NSAIDs at one-week prior to each study Visit.
• Subjects being treated with any known enzyme-altering drugs such as barbiturates, glucocorticoids, macrolides, antidepressants, neuroleptics, imidazole's, fluoroquinolones, calcium channel blockers, proton pump inhibitors, or H2-receptor antagonists, etc., within 30 days prior to screening or through the end of study.
• Subjects with difficulty fasting or consuming standard meals or snacks.

Sponsors & Collaborators

• Pharmanex: lead

Study Sites (1)

PCR Corp

Chelmsford, Essex, CM2 6UA, United Kingdom

Location

Study Officials

• Barrie Drewitt

  PCR Corp

  PRINCIPAL INVESTIGATOR

• Jamie Jarvis

  PCR Corp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 8, 2024
• Study Start: February 21, 2024
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)