Redefine for Muscle Maintenance During Caloric Restriction
(Redefine Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether a supplement called Redefine can help preserve muscle mass in individuals cutting calories. Reducing calorie intake often leads to muscle loss, affecting health and strength. The trial will compare Redefine to a placebo (a harmless pill with no active ingredients) to determine its effectiveness in maintaining muscle during dieting. Ideal participants are those currently taking semaglutide for weight loss with a Body Mass Index (BMI) between 25 and 34.9. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance muscle preservation during weight loss.
Do I have to stop taking my current medications for the trial?
You may need to stop taking certain medications, like diabetes medications or specific nutritional supplements that could interfere with the study. However, you can continue taking semaglutide and some supplements like fish oil, multivitamins, magnesium, vitamin D, and vitamin C.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the ingredients in Redefine, such as HMB, postbiotics, and plant extracts, are generally safe and well-tolerated. HMB supports muscle health and previous studies have confirmed its safety for healthy adults, with no major side effects reported at typical doses.
Calorie reduction, a component of this study, has been associated with benefits like improved muscle function and metabolism. Studies suggest that moderate calorie reduction usually does not cause harmful effects in healthy individuals. However, severe calorie reduction can lead to health issues such as reduced fertility and increased risk of weaker bones.
In summary, previous research indicates that the ingredients in Redefine are safe and generally well-tolerated when used appropriately.12345Why are researchers excited about this trial?
Researchers are excited about Redefine because it offers a novel approach to maintaining muscle during caloric restriction, which is often a challenge with traditional diet and exercise plans. Unlike other treatments that might focus solely on protein supplementation or resistance training, Redefine potentially works through a unique mechanism that directly targets muscle preservation, even when calories are reduced. This could make it a game-changer for people looking to lose weight without sacrificing muscle mass. Additionally, the trial includes different durations of treatment, offering insights into how timeframes might affect its efficacy.
What evidence suggests that Redefine might be an effective treatment for muscle maintenance during caloric restriction?
Studies have shown that cutting calories can lead to muscle loss, affecting physical ability and health. In this trial, participants will receive either Redefine or a placebo. Redefine contains HMB, postbiotics, and plant extracts, specifically designed to address this issue. Research suggests these ingredients may help maintain muscle strength and function. Early findings indicate that supplements with HMB can slow muscle loss. Additionally, postbiotics and plant extracts may support overall muscle health. Although human data remains limited, this combination of ingredients appears promising for maintaining muscle during calorie reduction.12678
Who Is on the Research Team?
Joseph Lamb, MD
Principal Investigator
Natures Sunshine
Are You a Good Fit for This Trial?
This trial is for adults with a BMI between 25 and 34.9 who are already taking semaglutide for weight loss at a stable dose. Participants must not have serious illnesses, certain infections, or be using specific supplements, medications, or substances that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants consume either Redefine or Placebo daily for 60 or 90 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Redefine
Trial Overview
The study tests the safety of Redefine—a nutritional formula containing HMB, postbiotics, and botanicals—compared to placebo in people on calorie restriction and semaglutide. The goal is to see if Redefine helps preserve muscle during dieting.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants consume Redefine daily for 90 days
Participants consume Redefine daily for 60 days
Participants consume Placebo daily for 60 days
Participants consume Placebo daily for 90 days
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nature's Sunshine Products, Inc.
Lead Sponsor
Citations
A Systematic Review and Meta-Analysis of the Effect of ... - PMC
Our review suggests that caloric restriction interventions up to 900 kilocalories per day are associated with a significant reduction in MM.
Redefine for Muscle Maintenance During Caloric Restriction
This study seeks to evaluate whether supplementation with Redefine may help preserve muscle mass and support the maintenance of healthy muscle ...
Effects of ten-week 30% caloric restriction on metabolic ...
Ten-week CR induces only limited improvements in skeletal muscle function, but leads to significant muscle wasting and weakness in both adult and old mice.
Impact of Caloric Restriction and Resistance Training on ...
Caloric restriction (CR) combined with resistance training (RT) produced the greatest reduction in body weight and insulin resistance in high‐ ...
Distinct and additive effects of calorie restriction ...
Calorie restriction (CR) potently extends health and lifespan, but is largely unachievable in humans, making “CR mimetics” of great interest. CR ...
Calorie restriction in humans: an update - PMC - NIH
Calorie restriction increases muscle mitochondrial biogenesis in healthy humans. ... Safety of two-year caloric restriction in non-obese healthy individuals.
Caloric restriction's impact on muscle mass, strength, and the ...
Caloric restriction has big benefits in terms of health span and perhaps lifespan.
Calorie Restriction with or without Time-Restricted Eating ...
We speculate that these data support the importance of caloric intake restriction when adhering to a regimen of time-restricted eating.
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