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Redefine for Muscle Maintenance During Caloric Restriction

(Redefine Trial)

BM
WG
Overseen ByWei Gao, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nature's Sunshine Products, Inc.
Must be taking: GLP-1 receptor agonist
Must not be taking: Diabetes medications, Narcotics, Anticoagulants, Corticosteroids
Disqualifiers: Serious unstable illness, HIV, TB, Hepatitis, others
Stay on Your Current MedsYou can continue your current medications while participating

What You Need to Know Before You Apply

What is the purpose of this trial?

Muscle loss during caloric restriction is a significant concern for metabolic health and physical function, yet there is limited evidence on interventions that simultaneously target multiple contributing pathways. This study investigates a multi-component formulation targeting these complementary pathways to address critical gaps in strategies for preserving lean mass during energy restriction. The primary goal of this study is to demonstrate the safety and tolerability of the product Redefine when used as an adjunct to a well-established caloric restriction regimen. Caloric restriction is known to result in unintended loss of skeletal muscle mass, which may negatively impact physical function and metabolic health. This study seeks to evaluate whether supplementation with Redefine may help preserve muscle mass and support the maintenance of healthy muscle function during caloric restriction. Secondarily, this study aims to explore whether Redefine supplementation may confer favorable changes in body composition in subjects participating in a caloric restriction regimen. This product consists of HMB, postbiotics and botanicals.

Who Is on the Research Team?

JL

Joseph Lamb, MD

Principal Investigator

Natures Sunshine

Are You a Good Fit for This Trial?

Inclusion Criteria

My BMI is between 25 and 34.9 while taking semaglutide.
Willing to give written informed consent to participate in the Study
I am taking semaglutide for weight loss and am ready to start a 1 mg weekly dose.

Exclusion Criteria

I am currently taking medication for diabetes.
POCBP not using effective contraception
I have been diagnosed with HIV, tuberculosis, or hepatitis B or C.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume either Redefine or Placebo daily for 60 or 90 days

8-13 weeks
3 visits (baseline, day-60, day-90)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Redefine

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Redefine for 90 daysExperimental Treatment1 Intervention
Group II: Redefine for 60 daysExperimental Treatment1 Intervention
Group III: Placebo for 60 daysPlacebo Group1 Intervention
Group IV: Placebo for 90 daysPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nature's Sunshine Products, Inc.

Lead Sponsor

Trials
4
Recruited
150+

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