A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience.

NCT06283732 | Completed

• 1 other identifier: 20392
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the effectiveness of a dietary supplement (greens powder), on improving digestive health, quality of life, energy levels, and satiety over a 14-day period. Participants, aged 18-65 and experiencing mild digestive issues, will consume the greens powder daily and report outcomes through diaries and questionnaires.

Conditions

Digestive System Disease

Keywords

Dietary Supplements; Digestive Health; Well-being; Energy Levels

Outcome Measures

Primary Outcomes (1)

• Digestive Health Improvement

  Measure the change in digestive health using daily diaries and the Bristol Stool Scale (BSS).

  14 days from the start of intervention

Secondary Outcomes (1)

• Quality of Life and Well-being Enhancement

  14 days from the start of intervention

Study Arms (1)

Dietary Supplement: Greens powder

EXPERIMENTAL

Participants are to consume one scoop (8.5 g) of the greens powder mixed in 8-10 oz of water every morning before breakfast for two weeks.

Dietary Supplement: Greens powder

Interventions

Greens powder DIETARY_SUPPLEMENT

Participants are to consume one scoop (8.5 g) of the greens powder mixed in 8-10 oz of water every morning before breakfast for two weeks.

Dietary Supplement: Greens powder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female.
• Aged 18-65 years.
• Willing to comply with study requirements.
• No known allergies to the ingredients listed in the product.
• Self-reported mild digestive issues (e.g., occasional bloating, stomach discomfort, occasional constipation, or occasional diarrhea).
• Generally healthy - do not live with any uncontrolled chronic disease .

You may not qualify if:

• Pre-existing chronic conditions that would prevent adherence to the protocol, including oncological and psychiatric disorders.
• Known severe allergic reactions that require an Epi-Pen.
• Women who are pregnant, breastfeeding, or attempting to conceive.
• History of severe diagnosed digestive disorders (e.g., IBS, IBD, Crohn's disease) or gastrointestinal-tract surgeries.
• Unwillingness to follow the study protocol.
• Invasive medical procedure within the last three weeks or planning one during the study period.
• History of substance abuse.
• Current participation or planning to participate in another research study.
• Regular consumption of probiotics, fiber, or prebiotic supplements within 3 weeks of the study.
• Regular intake of medications that may interfere with the study or study product (e.g., anticoagulants, laxatives, sedatives, beta-blockers, anti-acids) .

Sponsors & Collaborators

• Amway Corp: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Digestive System Diseases

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: February 22, 2024
• First Posted: February 28, 2024
• Study Start: November 15, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

US (1)