Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)ISOLATENCT07329088
Isoleucine Addition Treatment Effects in a Controlled Diet Study
A study testing L-Isoleucine and Low-isoleucine diet in people with Prediabetes (Insulin Resistance, Impaired Glucose Tolerance) and Metabolic Syndrome (MetS), run by Jean L. Fry at 1 site in United States.
Trial summary
The primary purpose of this study is to determine whether isoleucine repletion attenuates increases in insulin sensitivity typically observed when people with obesity follow a healthy, low-isoleucine diet. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Metabolic Syndrome (MetS), Obesity & Overweight
- What is being tested?
- L-Isoleucine and Low-isoleucine diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2026to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥ 30
- Meeting at least three metabolic syndrome criteria
- Follow an American style diet
Who cannot join
- Type 1 or 2 Diabetes diagnosis
- Medical condition or medication that affects insulin sensitivity, weight, or metabolism
- More than 5% weight change in 3 previous months
- Restrictive dietary pattern
- History of bariatric surgery
- Food allergy more severe than grade 1 on the CoFAR Grading Scale for Systemic Allergic Reactions, Version 3.0
- Allergy to lidocaine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ISOLeucine Addition Treatment Effects (ISOLATE) in a Controlled Diet Study
The primary purpose of this study is to determine whether isoleucine repletion attenuates increases in insulin sensitivity typically observed when people with obesity follow a healthy, low-isoleucine diet.
Read the detailed description
Isoleucine restriction promotes insulin sensitivity in preclinical models and is a promising strategy for preventing type 2 diabetes. This project aims to identify clinical and molecular changes in skeletal muscle and adipose tissues when adults with obesity switch from a typical American style diet to a plant-based diet low in isoleucine with or without isoleucine repletion.
- Conditions
- Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Metabolic Syndrome (MetS), Obesity & Overweight
- Being tested
- L-Isoleucine, Low-isoleucine diet
- Keywords
- L-Isoleucine, Insulin Resistance, Hyperglycemia, Muscle, Skeletal, Amino Acids, Prediabetic State, Diet, Mechanistic Target of Rapamycin Complex 1, Adipose Tissue, Body Composition
- Medical subject headings
- Prediabetic State, Insulin Resistance, Glucose Intolerance, Metabolic Syndrome, Obesity, Overweight, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-IsoleucineDietary supplement
Participants will follow a habitual American style diet. All participants transition to a healthy, low-isoleucine diet the study team provides, but only the isoleucine group receives isoleucine supplements to replete the overall diet to typical intake levels.
Low-isoleucine dietOther
Healthy, weight-maintaining, low-isoleucine meals and snacks will be provided directly to participants for 4 weeks. Diets are formulated by registered dietitians to meet energy, protein, and amino-acid requirements while minimizing weight change; target macronutrient distribution ≈ 10% protein / 60% carbohydrate / 30% fat38. Isoleucine content will meet minimum needs of 23 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Isoleucine group | Experimental | Participants will be randomized to receive low-isoleucine diet and isoleucine supplement Receives: Dietary Supplement: L-Isoleucine; Other: Low-isoleucine diet |
| Placebo group | Active comparator | Participants will be randomized to receive low-isoleucine diet and placebo supplement Receives: Other: Low-isoleucine diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity (M value)
The primary clinical outcome is insulin sensitivity, quantified as the M value derived from the hyperinsulinemic-euglycemic clamp. Hyperinsulinemic-euglycemic clamps will be performed to measure insulin sensitivity (IS). Briefly, after a ≥8 hour fast, participants will be admitted to the PC clinical unit and two IVs will be inserted; one for infusion, the other for blood draws. The primary metric will be an absolute change in M value from baseline to post intervention.
Measured: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the low-isoleucine diet and isoleucine vs placebo supplement intervention four weeks later.
Secondary outcomes (3)
Change in ratio of phosphorylation IRS-1 in skeletal muscle
Phosphorylation of IRS-1 at Ser636/639 will be quantified in skeletal muscle tissue obtained at baseline and after the intervention. Levels of phosphorylated IRS-1 and total IRS-1 will be measured, and the outcome will be expressed as the change in the phospho-to-total IRS-1 protein ratio from baseline to post-intervention.
Measured: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the low-isoleucine diet and isoleucine vs placebo supplement intervention four weeks later.
Absolute change in visceral fat
Abdominal adiposity will be assessed by computed tomography (CT). A single slice at the L4/L5level will be obtained at baseline and post-intervention. Visceral and subcutaneous fat volumes will be quantified using ImageJ.
Measured: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the low-isoleucine diet and isoleucine vs placebo supplement intervention four weeks later.
Change in ratio of phosphorylation Akt in skeletal muscle
Phosphorylation of Akt (Thr308 and Ser473) will be quantified in skeletal muscle tissue obtained at baseline and after the intervention. Levels of phosphorylated Akt and total Akt will be measured, and the outcome will be expressed as the change in the phospho-to-total Akt protein ratio from baseline to post-intervention.
Measured: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the low-isoleucine diet and isoleucine vs placebo supplement intervention four weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start4 May 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Why it stopped: The study was not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean L. Fry
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor-investigator, Jean L. Fry, University of Kentucky
- Investigators
- Jean Fry, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329088
- Sponsor's protocol ID
- 108059
- Other IDs
- P20GM156679
- Acronym
- ISOLATE
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doi M, Yamaoka I, Fukunaga T, Nakayama M. Isoleucine, a potent plasma glucose-lowering amino acid, stimulates glucose uptake in C2C12 myotubes. Biochem Biophys Res Commun. 2003 Dec 26;312(4):1111-7. doi: 10.1016/j.bbrc.2003.11.039.
PubMed 14651987Zhang S, Yang Q, Ren M, Qiao S, He P, Li D, Zeng X. Effects of isoleucine on glucose uptake through the enhancement of muscular membrane concentrations of GLUT1 and GLUT4 and intestinal membrane concentrations of Na+/glucose co-transporter 1 (SGLT-1) and GLUT2. Br J Nutr. 2016 Aug;116(4):593-602. doi: 10.1017/S0007114516002439.
PubMed 27464458Woo SL, Yang J, Hsu M, Yang A, Zhang L, Lee RP, Gilbuena I, Thames G, Huang J, Rasmussen A, Carpenter CL, Henning SM, Heber D, Wang Y, Li Z. Effects of branched-chain amino acids on glucose metabolism in obese, prediabetic men and women: a randomized, crossover study. Am J Clin Nutr. 2019 Jun 1;109(6):1569-1577. doi: 10.1093/ajcn/nqz024.
PubMed 31005973Drummond MJ, Bell JA, Fujita S, Dreyer HC, Glynn EL, Volpi E, Rasmussen BB. Amino acids are necessary for the insulin-induced activation of mTOR/S6K1 signaling and protein synthesis in healthy and insulin resistant human skeletal muscle. Clin Nutr. 2008 Jun;27(3):447-56. doi: 10.1016/j.clnu.2008.01.012. Epub 2008 Mar 14.
PubMed 18342407Yu D, Richardson NE, Green CL, Spicer AB, Murphy ME, Flores V, Jang C, Kasza I, Nikodemova M, Wakai MH, Tomasiewicz JL, Yang SE, Miller BR, Pak HH, Brinkman JA, Rojas JM, Quinn WJ 3rd, Cheng EP, Konon EN, Haider LR, Finke M, Sonsalla M, Alexander CM, Rabinowitz JD, Baur JA, Malecki KC, Lamming DW. The adverse metabolic effects of branched-chain amino acids are mediated by isoleucine and valine. Cell Metab. 2021 May 4;33(5):905-922.e6. doi: 10.1016/j.cmet.2021.03.025. Epub 2021 Apr 21.
PubMed 33887198Yeh CY, Chini LCS, Davidson JW, Garcia GG, Gallagher MS, Freichels IT, Calubag MF, Rodgers AC, Green CL, Babygirija R, Sonsalla MM, Pak HH, Trautman M, Hacker TA, Miller RA, Simcox J, Lamming DW. Late-life isoleucine restriction promotes physiological and molecular signatures of healthy aging. bioRxiv [Preprint]. 2024 Jan 9:2023.02.06.527311. doi: 10.1101/2023.02.06.527311.
PubMed 36798157Trautman ME, Richardson NE, Lamming DW. Protein restriction and branched-chain amino acid restriction promote geroprotective shifts in metabolism. Aging Cell. 2022 Jun;21(6):e13626. doi: 10.1111/acel.13626. Epub 2022 May 8.
PubMed 35526271Green CL, Trautman ME, Chaiyakul K, Jain R, Alam YH, Babygirija R, Pak HH, Sonsalla MM, Calubag MF, Yeh CY, Bleicher A, Novak G, Liu TT, Newman S, Ricke WA, Matkowskyj KA, Ong IM, Jang C, Simcox J, Lamming DW. Dietary restriction of isoleucine increases healthspan and lifespan of genetically heterogeneous mice. Cell Metab. 2023 Nov 7;35(11):1976-1995.e6. doi: 10.1016/j.cmet.2023.10.005.
PubMed 37939658Fontana L, Cummings NE, Arriola Apelo SI, Neuman JC, Kasza I, Schmidt BA, Cava E, Spelta F, Tosti V, Syed FA, Baar EL, Veronese N, Cottrell SE, Fenske RJ, Bertozzi B, Brar HK, Pietka T, Bullock AD, Figenshau RS, Andriole GL, Merrins MJ, Alexander CM, Kimple ME, Lamming DW. Decreased Consumption of Branched-Chain Amino Acids Improves Metabolic Health. Cell Rep. 2016 Jul 12;16(2):520-530. doi: 10.1016/j.celrep.2016.05.092. Epub 2016 Jun 23.
PubMed 27346343
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ISOLeucine Addition Treatment Effects (ISOLATE) in a Controlled Diet Study
- ClinicalTrials.gov ID
- NCT07329088
- Acronym / sponsor ID
- ISOLATE / 108059
- Conditions
- Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Metabolic Syndrome (MetS), Obesity & Overweight
- Keywords
- L-Isoleucine, Insulin Resistance, Hyperglycemia, Muscle, Skeletal, Amino Acids, Prediabetic State, Diet, Mechanistic Target of Rapamycin Complex 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jean L. FryUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 4 May 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to determine whether isoleucine repletion attenuates increases in insulin sensitivity typically observed when people with obesity follow a healthy, low-isoleucine diet.
Detailed description
Isoleucine restriction promotes insulin sensitivity in preclinical models and is a promising strategy for preventing type 2 diabetes. This project aims to identify clinical and molecular changes in skeletal muscle and adipose tissues when adults with obesity switch from a typical American style diet to a plant-based diet low in isoleucine with or without isoleucine repletion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isoleucine group | Experimental | Dietary Supplement: L-Isoleucine, Other: Low-isoleucine dietParticipants will be randomized to receive low-isoleucine diet and isoleucine supplement |
| Placebo group | Active comparator | Other: Low-isoleucine dietParticipants will be randomized to receive low-isoleucine diet and placebo supplement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI ≥ 30
- Meeting at least three metabolic syndrome criteria
- Follow an American style diet
Key exclusion criteria (7 listed)
- Type 1 or 2 Diabetes diagnosis
- Medical condition or medication that affects insulin sensitivity, weight, or metabolism
- More than 5% weight change in 3 previous months
- Restrictive dietary pattern
- History of bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-IsoleucineParticipants will follow a habitual American style diet. All participants transition to a healthy, low-isoleucine diet the study team provides, but only the isoleucine group receives isoleucine supplements to replete the overall diet to typical intake levels. | Dietary supplement | Isoleucine group |
| Low-isoleucine dietHealthy, weight-maintaining, low-isoleucine meals and snacks will be provided directly to participants for 4 weeks. Diets are formulated by registered dietitians to meet energy, protein, and amino-acid requirements while minimizing weight change; target macronutrient distribution ≈ 10% protein / 60% carbohydrate / 30% fat38. Isoleucine content will meet minimum needs of 23 mg/kg. | Other | Isoleucine group, Placebo group |
Primary outcome
Change in insulin sensitivity (M value)
Time frame: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the low-isoleucine diet and isoleucine vs placebo supplement intervention four weeks later.
The primary clinical outcome is insulin sensitivity, quantified as the M value derived from the hyperinsulinemic-euglycemic clamp. Hyperinsulinemic-euglycemic clamps will be performed to measure insulin sensitivity (IS). Briefly, after a ≥8 hour fast, participants will be admitted to the PC clinical unit and two IVs will be inserted; one for infusion, the other for blood draws. The primary metric will be an absolute change in M value from baseline to post intervention.
3 secondary outcomes
Change in ratio of phosphorylation IRS-1 in skeletal muscle
Time frame: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the low-isoleucine diet and isoleucine vs placebo supplement intervention four weeks later.
Absolute change in visceral fat
Time frame: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the low-isoleucine diet and isoleucine vs placebo supplement intervention four weeks later.
Change in ratio of phosphorylation Akt in skeletal muscle
Time frame: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the low-isoleucine diet and isoleucine vs placebo supplement intervention four weeks later.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 14651987Doi M, Yamaoka I, Fukunaga T, Nakayama M. Isoleucine, a potent plasma glucose-lowering amino acid, stimulates glucose uptake in C2C12 myotubes. Biochem Biophys Res Commun. 2003 Dec 26;312(4):1111-7. doi: 10.1016/j.bbrc.2003.11.039.
- Background: PubMed 27464458Zhang S, Yang Q, Ren M, Qiao S, He P, Li D, Zeng X. Effects of isoleucine on glucose uptake through the enhancement of muscular membrane concentrations of GLUT1 and GLUT4 and intestinal membrane concentrations of Na+/glucose co-transporter 1 (SGLT-1) and GLUT2. Br J Nutr. 2016 Aug;116(4):593-602. doi: 10.1017/S0007114516002439.
- Background: PubMed 31005973Woo SL, Yang J, Hsu M, Yang A, Zhang L, Lee RP, Gilbuena I, Thames G, Huang J, Rasmussen A, Carpenter CL, Henning SM, Heber D, Wang Y, Li Z. Effects of branched-chain amino acids on glucose metabolism in obese, prediabetic men and women: a randomized, crossover study. Am J Clin Nutr. 2019 Jun 1;109(6):1569-1577. doi: 10.1093/ajcn/nqz024.
- Background: PubMed 18342407Drummond MJ, Bell JA, Fujita S, Dreyer HC, Glynn EL, Volpi E, Rasmussen BB. Amino acids are necessary for the insulin-induced activation of mTOR/S6K1 signaling and protein synthesis in healthy and insulin resistant human skeletal muscle. Clin Nutr. 2008 Jun;27(3):447-56. doi: 10.1016/j.clnu.2008.01.012. Epub 2008 Mar 14.
- Background: PubMed 33887198Yu D, Richardson NE, Green CL, Spicer AB, Murphy ME, Flores V, Jang C, Kasza I, Nikodemova M, Wakai MH, Tomasiewicz JL, Yang SE, Miller BR, Pak HH, Brinkman JA, Rojas JM, Quinn WJ 3rd, Cheng EP, Konon EN, Haider LR, Finke M, Sonsalla M, Alexander CM, Rabinowitz JD, Baur JA, Malecki KC, Lamming DW. The adverse metabolic effects of branched-chain amino acids are mediated by isoleucine and valine. Cell Metab. 2021 May 4;33(5):905-922.e6. doi: 10.1016/j.cmet.2021.03.025. Epub 2021 Apr 21.
- Background: PubMed 36798157Yeh CY, Chini LCS, Davidson JW, Garcia GG, Gallagher MS, Freichels IT, Calubag MF, Rodgers AC, Green CL, Babygirija R, Sonsalla MM, Pak HH, Trautman M, Hacker TA, Miller RA, Simcox J, Lamming DW. Late-life isoleucine restriction promotes physiological and molecular signatures of healthy aging. bioRxiv [Preprint]. 2024 Jan 9:2023.02.06.527311. doi: 10.1101/2023.02.06.527311.
- Background: PubMed 35526271Trautman ME, Richardson NE, Lamming DW. Protein restriction and branched-chain amino acid restriction promote geroprotective shifts in metabolism. Aging Cell. 2022 Jun;21(6):e13626. doi: 10.1111/acel.13626. Epub 2022 May 8.
- Background: PubMed 37939658Green CL, Trautman ME, Chaiyakul K, Jain R, Alam YH, Babygirija R, Pak HH, Sonsalla MM, Calubag MF, Yeh CY, Bleicher A, Novak G, Liu TT, Newman S, Ricke WA, Matkowskyj KA, Ong IM, Jang C, Simcox J, Lamming DW. Dietary restriction of isoleucine increases healthspan and lifespan of genetically heterogeneous mice. Cell Metab. 2023 Nov 7;35(11):1976-1995.e6. doi: 10.1016/j.cmet.2023.10.005.
- Background: PubMed 27346343Fontana L, Cummings NE, Arriola Apelo SI, Neuman JC, Kasza I, Schmidt BA, Cava E, Spelta F, Tosti V, Syed FA, Baar EL, Veronese N, Cottrell SE, Fenske RJ, Bertozzi B, Brar HK, Pietka T, Bullock AD, Figenshau RS, Andriole GL, Merrins MJ, Alexander CM, Kimple ME, Lamming DW. Decreased Consumption of Branched-Chain Amino Acids Improves Metabolic Health. Cell Rep. 2016 Jul 12;16(2):520-530. doi: 10.1016/j.celrep.2016.05.092. Epub 2016 Jun 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Fry, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Isoleucine and Low-isoleucine diet in people with Prediabetes (Insulin Resistance, Impaired Glucose Tolerance) and Metabolic Syndrome (MetS), run by Jean L. Fry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin sensitivity (M value) (time frame: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the low-isoleucine diet and isoleucine vs placebo supplement intervention four weeks later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07329088, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.