A Clinical Trial to Assess the Effect of a Combined Pre-, Pro-, and Post-biotic Supplement on Gut and Metabolic Health

NCT05876845 | Completed

• 1 other identifier: 20291
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This is a virtual, single-arm clinical trial that will last 4-weeks. Participants will take the supplement daily and complete questionnaires at baseline, week 2, and week 4. Participants will provide photos of their face and stomach at baseline and week 4. Gut health and associated health outcomes, including brain, skin, and immune function, will be evaluated at baseline and at each check-in. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores. Baseline and endline photos from each study part will be provided by participants.

Conditions

Gut Health

Outcome Measures

Primary Outcomes (2)

• Change in participant-reported gastrointestinal symptoms [Time Frame: Baseline to 4 weeks]

  Assessed via study-specific questionnaires to gather information on improvements in bloating, digestion, stool regularity, stool quality, and gas. Survey-based assessments (0-5, 0-6 point scale) of changes in bloating, digestion, stool regularity, stool quality, and gas.

  4 weeks

• Change in scores on the Gastrointestinal Symptom Rating Scale (GSRS) [Time Frame: Baseline to 4

  Use of validated questionnaire the GSRS to assess gastrointestinal symptoms.The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters reporting on Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents no symptoms and 7 represents severe symptoms.

  4 weeks

Study Arms (1)

Intervention Group

EXPERIMENTAL

Other: Combined pre-, pro-, and post-biotic supplement

Interventions

Combined pre-, pro-, and post-biotic supplement OTHER

Participants will take 2 capsules daily with water, with their first meal of the day.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women
• years of age or older
• Experience at least one of the following symptoms: regular bloating/gas, irregular bowel movements, heartburn, or poor digestive health
• Generally healthy

You may not qualify if:

• Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
• Allergic to bees, bee products, poplar tree products, or balsam of Peru
• Anyone with known severe allergic reactions.
• Women who are pregnant, breastfeeding or attempting to become pregnant
• Unwilling to follow the study protocol.
• Has introduced any new forms of medication or supplements targeting gut health within the last 3 months
• Has taken antibiotics in the last 3 months

Sponsors & Collaborators

• Beekeeper's Naturals Inc: lead

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Interventions

Proline

Intervention Hierarchy (Ancestors)

Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 26, 2023
• Study Start: February 9, 2023
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-05

Locations

US (1)