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

NCT ID: NCT06283732

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2024-02-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dietary Supplement: Greens powder

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.

Group Type: EXPERIMENTAL

Greens powder

Intervention Type: 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.

Interventions

Greens powder

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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 .

Exclusion Criteria

• 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) .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Amway Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

20392

Identifier Type: -

Identifier Source: org_study_id