An Open Label Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes

Part of paid clinical trials in Del Mar, California.

Sponsor
PepsiCo Global R&D
Study ID
NCT07563855
Status
Recruiting
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Conditions

  • Health
  • Quality of Life
  • Wellness

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • A ready-to-mix beverage containing protein, fiber, and electrolytes — DIETARY_SUPPLEMENT
    Subjects will consume the ready-to-mix beverage ad-libitum over the 4-week study period.

Study Details

The purpose of this study is to: 1. Understand the participant experience using a health and wellness product and effects of the study product on GLP-1 users and those trying to lose weight 2. Understand how participants may use and accept a health and wellness product 3. Understand the side effects of a health and wellness product 4. Evaluate the quality and effects of a health and wellness product on participant health through self-reported measures (electronic surveys) and biomarker collections.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
133 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: GLP-1 Users and Non-users
    Participants currently taking a GLP-1 for 3 months or longer, or wishing to lose weight, but not currently on a GLP-1

Primary Outcome Measure

PROMIS Constipation 9A [ Time Frame: At baseline and weeks 1-4 of the intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virtual study. Managed by Radicle Science Inc.Del MarCalifornia90214
Radicle Science Inc.
[email protected]
760-281-3898
Susan Hewlings, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Virtual study. Managed by Radicle Science Inc.· Del Mar, CA

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