L-Isoleucine for Obesity
(ISOLATE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether adding an isoleucine supplement (an amino acid) can improve insulin sensitivity in people with obesity who follow a low-isoleucine diet. Participants will divide into two groups: one will receive the isoleucine supplement, and the other will receive a placebo. This study may suit individuals with a BMI of 30 or higher, who follow a typical American diet, and meet at least three criteria for metabolic syndrome, such as high blood pressure or high blood sugar.
As an unphased trial, this study provides a unique opportunity to contribute to scientific understanding and potentially improve health outcomes for those with metabolic syndrome.
Will I have to stop taking my current medications?
The trial excludes people taking medications that affect insulin sensitivity, weight, or metabolism, so you may need to stop such medications to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that L-Isoleucine is usually safe for people. This amino acid is commonly found in many foods. Previous studies have explored its impact on metabolism. Although researchers conducted these studies on animals, they provide some hints about safety. For instance, one study found that isoleucine might help prevent obesity-related problems in mice, such as insulin resistance. This suggests it could be safe for humans too.
However, since this trial is in the "Not Applicable" phase, uncertainty remains about isoleucine's safety for this specific use in humans. Researchers aim to learn more about its effects. Always consult a healthcare provider before joining a trial to ensure it's right for you.12345Why are researchers excited about this trial?
Unlike standard obesity treatments that often involve lifestyle changes, medications, or surgery, L-Isoleucine offers a novel approach by leveraging an amino acid supplement. Researchers are excited about L-Isoleucine because it targets metabolic pathways differently, potentially impacting the body's ability to process and store fat. This unique mechanism could provide an alternative for those who struggle with conventional methods, offering a new avenue for managing obesity.
What evidence suggests that L-Isoleucine might be an effective treatment for obesity?
Research shows that isoleucine, a type of protein building block, might not reverse obesity but could help prevent it. Some animal studies have found that reducing isoleucine intake can improve the body's ability to use sugar, aiding weight management and overall health. However, taking extra isoleucine as a supplement has not been proven to help with obesity in people. In this trial, participants in the isoleucine group will receive a low-isoleucine diet and an isoleucine supplement, while those in the placebo group will receive a low-isoleucine diet and a placebo supplement. While isoleucine may benefit metabolism, strong evidence does not support its direct role in treating obesity.56789
Who Is on the Research Team?
Jean Fry, PhD
Principal Investigator
University of Kentucky
Are You a Good Fit for This Trial?
This trial is for adults with obesity (BMI ≥ 30) who typically eat an American style diet and meet at least three criteria of metabolic syndrome. It's not for those who've had significant weight changes recently, have diabetes, follow a restrictive diet, had bariatric surgery, severe food allergies, lidocaine allergy or take meds that affect insulin sensitivity.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants transition from a typical American diet to a plant-based diet low in isoleucine
Treatment
Participants receive a low-isoleucine diet with either isoleucine supplementation or placebo
Follow-up
Participants are monitored for changes in insulin sensitivity and other metabolic markers
What Are the Treatments Tested in This Trial?
Interventions
- L-Isoleucine
Trial Overview
The study tests if adding the amino acid L-Isoleucine to a low-isoleucine diet can improve insulin sensitivity in people with obesity. Participants will adhere to this special controlled diet to see if it influences their metabolism positively.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will be randomized to receive low-isoleucine diet and isoleucine supplement
Participants will be randomized to receive low-isoleucine diet and placebo supplement
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jean L. Fry
Lead Sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
Citations
The Effect of Isoleucine Supplementation on Body Weight ...
Therefore, the findings suggest that isoleucine may be able to prevent diet-induced obesity, but may not be an effective treatment for reversing ...
Dietary isoleucine content modulates the metabolic and ...
Restriction of isoleucine is sufficient to promote metabolic health in lean mice, improving glucose tolerance through increased hepatic insulin sensitivity and ...
Isoleucine‐restricted diets improve high‐fat diet‐induced ...
Our studies support that restricting isoleucine in high-fat diets was a novel means of preventing obesity-induced NAFLD and insulin resistance.
4.
news.wisc.edu
news.wisc.edu/mice-eating-less-of-specific-amino-acid-overrepresented-in-diet-of-obese-people-live-longer-healthier/Mice eating less of specific amino acid — overrepresented in ...
“Very quickly, we saw the mice on the reduced isoleucine diet lose adiposity — their bodies got leaner, they lost fat,” says Lamming, while the ...
Dietary restriction of isoleucine increases healthspan and ...
Overall, we found that a Low Ile diet was able to reduce weight gain and improve glycemic control in young HET3 mice and was more effective at ...
The adverse metabolic effects of branched-chain amino acids ...
A low isoleucine diet reprograms liver and adipose metabolism, increasing hepatic insulin sensitivity and ketogenesis, and increasing energy expenditure, ...
Isoleucine Prevents the Accumulation of Tissue ...
Our current data indicate, however, that Ile may prevent the development of visceral obesity and hyperinsulinemia by affecting WAT, liver, and muscle adiposity ...
The Effect of Isoleucine Supplementation on Body Weight ...
This study aimed to investigate the impact of chronic isoleucine on body weight gain and glucose tolerance in lean and high-fat-diet (HFD) induced-obese mice.
9.
lamminglab.medicine.wisc.edu
lamminglab.medicine.wisc.edu/wp-content/uploads/sites/1341/2023/12/Yu-and-Richardson-et-al-2021-Cell-Metabolism.pdfThe adverse metabolic effects of branched-chain amino acids ...
Reducing isoleucine or valine rapidly restores metabolic health to diet-induced obese mice. Finally, we demonstrate that variation in dietary isoleucine levels ...
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