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Health Beverage for Constipation

SH
Overseen BySusan Hewings, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new ready-to-mix health beverage to assess its effects on individuals experiencing constipation, particularly those using GLP-1 products (medications that help control blood sugar and appetite) or attempting to lose weight. The study examines participants' usage and perceptions of the beverage, its side effects, and its impact on overall health. Participants will share their experiences through surveys and provide samples, such as blood and stool, for deeper analysis. Ideal candidates have been taking a GLP-1 for over three months or are interested in losing weight without recently using a GLP-1. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve health outcomes for many.

Do I need to stop taking my current medications for the trial?

You may need to stop taking certain medications if they interact with the study product. Specifically, if you are on medications like anticoagulants, antihypertensives, or others listed in the exclusion criteria, you might not be eligible to participate. The protocol does not specify a washout period, but it's important to discuss your current medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that similar ready-to-drink products, like those used for bowel cleansing, are usually easy to tolerate. In past studies, most participants found these drinks easy or acceptable to consume, with serious side effects being rare. The most common issues were mild, such as nausea and headaches, affecting only a few participants.

The trial drink might cause some side effects, but past research suggests these are likely to be minor. Participants should monitor their body's reactions to any new product and report any concerns to the study team.12345

Why are researchers excited about this trial?

Unlike standard treatments for constipation, which often involve laxatives or fiber supplements, this ready-to-mix beverage offers a unique approach. Researchers are excited because it targets gut health through a potentially more natural method, aiming to ease constipation without the harsh side effects sometimes seen with traditional options. Additionally, this beverage is designed for convenience, providing an easy-to-use solution that fits seamlessly into daily routines, especially for people already using GLP-1 medications or looking to manage weight.

What evidence suggests that this ready-to-mix beverage might be an effective treatment for constipation?

Research has shown that certain drinks might help relieve constipation. For example, one study found that a specific hot-water extract mixture improved constipation by making it easier to pass stools. Drinking high-fiber beverages, especially those with added water, may also ease constipation symptoms. Probiotic drinks have improved stool consistency and reduced stomach issues. This trial will evaluate a ready-to-mix beverage, which participants will use, to determine its potential effectiveness in relieving constipation.46789

Who Is on the Research Team?

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Susan Hewlings, PhD

Principal Investigator

Radicle Science Inc.

Are You a Good Fit for This Trial?

This trial is for adults aged 21-75 in the US who are either taking a GLP-1 medication for at least 3 months or want to lose weight but haven't used a GLP-1 recently. Participants must be willing to drink the study beverage daily for 4 weeks and provide stool and blood samples.

Inclusion Criteria

I am willing to take the study product every day for 4 weeks.
I am between 21 and 75 years old.
I am willing to give stool and blood samples at the start and end of the study.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants use a health and wellness product and report effects through electronic surveys and biomarker collections

4 weeks
Weekly self-reported measures and biomarker collections

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Ready-to-mix beverage

Trial Overview

The study tests a ready-to-mix drink with protein, fiber, and electrolytes to see its effects on gut health, quality of life, and wellness. Participants will report their experiences through surveys and biomarker samples before and after using the product.

How Is the Trial Designed?

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Treatment groups

Experimental Treatment

Group I: GLP-1 Users and Non-usersExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

PepsiCo Global R&D

Lead Sponsor

Trials
99
Recruited
13,600+

Ramon Laguarta

PepsiCo Global R&D

Chief Executive Officer since 2018

MBA from ESADE Business School

Mark Kirkham

PepsiCo Global R&D

Chief Marketing Officer

Bachelor's degree in Business Administration from Trinity College Dublin

Radicle Science Inc.

Collaborator

Citations

Laxative Activity of the Hot-Water Extract Mixture of Hovenia ...

In this study the results demonstrated that HP mixed extract can elevate the symptoms of constipation through the improvement of fecal excretion, and the ...

Systematic review and meta‐analysis: Foods, drinks ...

Interestingly, one RCT showed that water supplementation (2 L/day) alongside a high-fibre diet (25 g/day) may improve constipation. However, ...

A randomized, double-blind, controlled human study

EPS-enriched VP30 fermented milk was more effective in increasing defecation frequency, defecation volume, and fecal type during the 4-week treatment.

Probiotic SYNBIO® Blend's Impact on Constipation in ...

Overall, the SYNBIO® blend significantly improved constipation relief by 0.75 (95% CI: 0.31 to 1.19; p = 0.0008) in 52% of the subjects, and ...

'Gold standard evidence' supports use of probiotic blend to ...

Adults with occasional constipation reported significant improvement in stool consistency and GI-related symptoms after receiving a probiotic blend.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32313553/

Efficacy, safety, and tolerability of a ready-to-drink bowel ...

Ready-to-drink SPMC oral solution had consistent, good quality colon cleansing, and favorable tolerability among participants of all BMI groups.

Efficacy, safety, and tolerability of a ready-to-drink bowel ...

Greater than 83% of participants in any BMI group found the preparation 'easy' or 'acceptable' to ingest, and the majority (>58%) rated SPMC oral solution as ' ...

Efficacy and safety of a ready-to-drink bowel preparation ...

Most common adverse events were nausea (3.1% versus 2.9%), headache (2.7% versus 3.1%), hypermagnesemia (2.0% versus 5.1%), and vomiting (1.3% ...

Still Constipated? Why Polyethylene Glycol Works & Medically ...

Unlike stimulant laxatives, polyethylene glycol does not force your intestines to contract. Instead, it works gently by improving stool ...