Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)NCT06571279
Assessing the Impact of a Plant-Based Diet for Diabetes Prevention
A study testing Plant-based diet in people with Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by Jean L. Fry at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the sex-specific metabolic and molecular response, among adults with prediabetes, when moving from a Western Diet to plant-based diet. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
- What is being tested?
- Plant-based diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2024to 25 Nov 2025
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index greater than or equal to 27
- High waist circumference (women greater than or equal to 35"; men greater than or equal to 40")
- Prediabetes (based on fasting glucose 100-125 mg/dL, HbA1c 5.7-6.4, or 2-hr post-oral glucose tolerance test glucose screen between 140-199mg/dL)
- Physical activity below national guidelines
- Aged 30-55 (premenopausal for women)
- Following a Western diet
Who cannot join
- Diabetes diagnosis
- Take medications that may affect insulin sensitivity
- More than 5% weight change within 6 months of screening
- History of bariatric surgery
- Report any dietary supplement, medication, or medical condition known to significantly affect weight or metabolism
- Take hormone replacement therapy
- Consume 3 or more servings of combined fruit and vegetables daily and/or 3 or more servings of whole grains daily
- Any food allergy more severe than grade 1 on the CoFAR Grading Scale for Systemic Allergic Reactions, Version 3.0 or allergy to lidocaine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky CCTS
Lexington, Kentucky, 40536
About this study
The primary purpose of this study is to determine the sex-specific metabolic and molecular response, among adults with prediabetes, when moving from a Western Diet to plant-based diet.
Read the detailed description
Plant-based diets that are abundant in myoinsitol and D-chiro inositol (MI and DCI) increase insulin sensitivity by promotion of insulin signaling lowering serum insulin and improving insulin resistance. The Western diet contributes to chronic metabolic inflammation often leading to the development of metabolic diseases. There is known metabolic improvement among men compared to women when following a plant-based diet or intensive lifestyle modifications. Through this study we look to identify the pathways in which plant-based diet impact skeletal muscle inositol metabolites among sexes (men vs. women) and improve insulin sensitivity.
- Being tested
- Plant-based diet
- Medical subject headings
- Prediabetic State, Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based dietOther
Standard plant-based meals will be provided directly to participants. The dietary intervention will begin with a one-week Western diet run-in; hereafter, participants will consume plant-based meals for approximately 5 weeks. Total energy provided will be equal to REE X 1.4 to account for light physical activity to support weight maintenance. High-inositol snacks will be provided to meet energy needs. Meals and snacks combined will provide a minimum of 20mg total inositol/kg body weight. For example, a 200lb participant will consume 1.8g daily, which is consistent with doses used in prior studies.
| Study group | Role | What they receive |
|---|---|---|
| Plant-based diet | Other | 5 weeks of plant-based meals and snacks. Receives: Other: Plant-based diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity (glucose infusion rate)
This gold standard test for IS will be performed at baseline and post-intervention with support of the COBRE Phenotyping core. After ≥8 hour fast, participants will be admitted to our Center for Clinical and Translational Science (CCTS) and two IVs inserted; one for infusion, the other for blood draws (see Phenotyping core). The primary outcome is the glucose infusion rate (GIR), a direct measure of whole body IS, which will enable us to detect even small changes in IS in response to the intervention. COBRE mentor Dr. Kern is proficient in use of these methods The primary clinical outcome is the change in GIR from post run-in 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 plant-based diet intervention five weeks later.
Skeletal muscle d-chiroinositol content
Muscle samples will be homogenized, then inositol compounds will be extracted using solvents. In the prepared samples, D-chiroinositol content will be assessed by a commercial service using LC-MS/MS.
Measured: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.
Secondary outcomes (3)
Phosphorylation status of insulin signaling molecules in skeletal muscle
Upon insulin stimulation, insulin-responsive signaling proteins are phosphorylated to initiate downstream effects. The ratio of phosphorylated and unphosphorylated, as well as total protein, per standard unit of skeletal muscle will be determined.
Measured: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.
Absolute change in visceral fat (g)
Computed tomography will be used to measure visceral fat
Measured: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.
Fasting blood glucose
Baseline measure of fasting blood glucose are measured via YSI before the start of the OGTT
Measured: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start14 Oct 2024
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean L. Fry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean L. Fry, University of Kentucky
- Investigators
- Jean L Fry, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571279
- Sponsor's protocol ID
- 95349
- Status last verified
- Dec 2025
- First submitted
- 22 Aug 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bedard A, Riverin M, Dodin S, Corneau L, Lemieux S. Sex differences in the impact of the Mediterranean diet on cardiovascular risk profile. Br J Nutr. 2012 Oct 28;108(8):1428-34. doi: 10.1017/S0007114511006969. Epub 2012 Jan 6.
PubMed 22221517Chen Z, Zuurmond MG, van der Schaft N, Nano J, Wijnhoven HAH, Ikram MA, Franco OH, Voortman T. Plant versus animal based diets and insulin resistance, prediabetes and type 2 diabetes: the Rotterdam Study. Eur J Epidemiol. 2018 Sep;33(9):883-893. doi: 10.1007/s10654-018-0414-8. Epub 2018 Jun 8.
PubMed 29948369Perreault L, Ma Y, Dagogo-Jack S, Horton E, Marrero D, Crandall J, Barrett-Connor E; Diabetes Prevention Program. Sex differences in diabetes risk and the effect of intensive lifestyle modification in the Diabetes Prevention Program. Diabetes Care. 2008 Jul;31(7):1416-21. doi: 10.2337/dc07-2390. Epub 2008 Mar 20.
PubMed 18356403Leblanc V, Begin C, Hudon AM, Royer MM, Corneau L, Dodin S, Lemieux S. Gender differences in the long-term effects of a nutritional intervention program promoting the Mediterranean diet: changes in dietary intakes, eating behaviors, anthropometric and metabolic variables. Nutr J. 2014 Nov 22;13:107. doi: 10.1186/1475-2891-13-107.
PubMed 25416917Sargrad KR, Homko C, Mozzoli M, Boden G. Effect of high protein vs high carbohydrate intake on insulin sensitivity, body weight, hemoglobin A1c, and blood pressure in patients with type 2 diabetes mellitus. J Am Diet Assoc. 2005 Apr;105(4):573-80. doi: 10.1016/j.jada.2005.01.009.
PubMed 15800559Bedard A, Tchernof A, Lamarche B, Corneau L, Dodin S, Lemieux S. Effects of the traditional Mediterranean diet on adiponectin and leptin concentrations in men and premenopausal women: do sex differences exist? Eur J Clin Nutr. 2014 May;68(5):561-6. doi: 10.1038/ejcn.2014.27. Epub 2014 Mar 5.
PubMed 24595221Minambres I, Cuixart G, Goncalves A, Corcoy R. Effects of inositol on glucose homeostasis: Systematic review and meta-analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1146-1152. doi: 10.1016/j.clnu.2018.06.957. Epub 2018 Jun 21.
PubMed 29980312Soldevila-Domenech N, Pastor A, Sala-Vila A, Lazaro I, Boronat A, Munoz D, Castaner O, Fagundo B, Corella D, Fernandez-Aranda F, Martinez-Gonzalez MA, Salas-Salvado J, Fito M, de la Torre R. Sex differences in endocannabinoids during 3 years of Mediterranean diet intervention: Association with insulin resistance and weight loss in a population with metabolic syndrome. Front Nutr. 2022 Dec 1;9:1076677. doi: 10.3389/fnut.2022.1076677. eCollection 2022.
PubMed 36532543Brennan L, Gibbons H. Sex matters: a focus on the impact of biological sex on metabolomic profiles and dietary interventions. Proc Nutr Soc. 2020 May;79(2):205-209. doi: 10.1017/S002966511900106X. Epub 2019 Jul 31.
PubMed 31362802Larner J, Brautigan DL, Thorner MO. D-chiro-inositol glycans in insulin signaling and insulin resistance. Mol Med. 2010 Nov-Dec;16(11-12):543-52. doi: 10.2119/molmed.2010.00107. Epub 2010 Aug 27.
PubMed 20811656
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of a Plant-Based Diet for Diabetes Prevention
- ClinicalTrials.gov ID
- NCT06571279
- Acronym / sponsor ID
- 95349
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Jean L. FryUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 26 Aug 2024 (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 the sex-specific metabolic and molecular response, among adults with prediabetes, when moving from a Western Diet to plant-based diet.
Detailed description
Plant-based diets that are abundant in myoinsitol and D-chiro inositol (MI and DCI) increase insulin sensitivity by promotion of insulin signaling lowering serum insulin and improving insulin resistance. The Western diet contributes to chronic metabolic inflammation often leading to the development of metabolic diseases. There is known metabolic improvement among men compared to women when following a plant-based diet or intensive lifestyle modifications. Through this study we look to identify the pathways in which plant-based diet impact skeletal muscle inositol metabolites among sexes (men vs. women) and improve insulin sensitivity.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plant-based diet | Other | Other: Plant-based diet5 weeks of plant-based meals and snacks. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body mass index greater than or equal to 27
- High waist circumference (women greater than or equal to 35"; men greater than or equal to 40")
- Prediabetes (based on fasting glucose 100-125 mg/dL, HbA1c 5.7-6.4, or 2-hr post-oral glucose tolerance test glucose screen between 140-199mg/dL)
- Physical activity below national guidelines
- Aged 30-55 (premenopausal for women)
Key exclusion criteria (8 listed)
- Diabetes diagnosis
- Take medications that may affect insulin sensitivity
- More than 5% weight change within 6 months of screening
- History of bariatric surgery
- Report any dietary supplement, medication, or medical condition known to significantly affect weight or metabolism
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 |
|---|---|---|
| Plant-based dietStandard plant-based meals will be provided directly to participants. The dietary intervention will begin with a one-week Western diet run-in; hereafter, participants will consume plant-based meals for approximately 5 weeks. Total energy provided will be equal to REE X 1.4 to account for light physical activity to support weight maintenance. High-inositol snacks will be provided to meet energy needs. Meals and snacks combined will provide a minimum of 20mg total inositol/kg body weight. For example, a 200lb participant will consume 1.8g daily, which is consistent with doses used in prior studies. | Other | Plant-based diet |
Primary outcome
Insulin sensitivity (glucose infusion rate)
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 plant-based diet intervention five weeks later.
This gold standard test for IS will be performed at baseline and post-intervention with support of the COBRE Phenotyping core. After ≥8 hour fast, participants will be admitted to our Center for Clinical and Translational Science (CCTS) and two IVs inserted; one for infusion, the other for blood draws (see Phenotyping core). The primary outcome is the glucose infusion rate (GIR), a direct measure of whole body IS, which will enable us to detect even small changes in IS in response to the intervention. COBRE mentor Dr. Kern is proficient in use of these methods The primary clinical outcome is the change in GIR from post run-in to post intervention.
Skeletal muscle d-chiroinositol content
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 plant-based diet intervention five weeks later.
Muscle samples will be homogenized, then inositol compounds will be extracted using solvents. In the prepared samples, D-chiroinositol content will be assessed by a commercial service using LC-MS/MS.
3 secondary outcomes
Phosphorylation status of insulin signaling molecules 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 plant-based diet intervention five weeks later.
Absolute change in visceral fat (g)
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 plant-based diet intervention five weeks later.
Fasting blood glucose
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 plant-based diet intervention five weeks later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Background: PubMed 22221517Bedard A, Riverin M, Dodin S, Corneau L, Lemieux S. Sex differences in the impact of the Mediterranean diet on cardiovascular risk profile. Br J Nutr. 2012 Oct 28;108(8):1428-34. doi: 10.1017/S0007114511006969. Epub 2012 Jan 6.
- Background: PubMed 29948369Chen Z, Zuurmond MG, van der Schaft N, Nano J, Wijnhoven HAH, Ikram MA, Franco OH, Voortman T. Plant versus animal based diets and insulin resistance, prediabetes and type 2 diabetes: the Rotterdam Study. Eur J Epidemiol. 2018 Sep;33(9):883-893. doi: 10.1007/s10654-018-0414-8. Epub 2018 Jun 8.
- Background: PubMed 18356403Perreault L, Ma Y, Dagogo-Jack S, Horton E, Marrero D, Crandall J, Barrett-Connor E; Diabetes Prevention Program. Sex differences in diabetes risk and the effect of intensive lifestyle modification in the Diabetes Prevention Program. Diabetes Care. 2008 Jul;31(7):1416-21. doi: 10.2337/dc07-2390. Epub 2008 Mar 20.
- Background: PubMed 25416917Leblanc V, Begin C, Hudon AM, Royer MM, Corneau L, Dodin S, Lemieux S. Gender differences in the long-term effects of a nutritional intervention program promoting the Mediterranean diet: changes in dietary intakes, eating behaviors, anthropometric and metabolic variables. Nutr J. 2014 Nov 22;13:107. doi: 10.1186/1475-2891-13-107.
- Background: PubMed 15800559Sargrad KR, Homko C, Mozzoli M, Boden G. Effect of high protein vs high carbohydrate intake on insulin sensitivity, body weight, hemoglobin A1c, and blood pressure in patients with type 2 diabetes mellitus. J Am Diet Assoc. 2005 Apr;105(4):573-80. doi: 10.1016/j.jada.2005.01.009.
- Background: PubMed 24595221Bedard A, Tchernof A, Lamarche B, Corneau L, Dodin S, Lemieux S. Effects of the traditional Mediterranean diet on adiponectin and leptin concentrations in men and premenopausal women: do sex differences exist? Eur J Clin Nutr. 2014 May;68(5):561-6. doi: 10.1038/ejcn.2014.27. Epub 2014 Mar 5.
- Background: PubMed 29980312Minambres I, Cuixart G, Goncalves A, Corcoy R. Effects of inositol on glucose homeostasis: Systematic review and meta-analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1146-1152. doi: 10.1016/j.clnu.2018.06.957. Epub 2018 Jun 21.
- Background: PubMed 36532543Soldevila-Domenech N, Pastor A, Sala-Vila A, Lazaro I, Boronat A, Munoz D, Castaner O, Fagundo B, Corella D, Fernandez-Aranda F, Martinez-Gonzalez MA, Salas-Salvado J, Fito M, de la Torre R. Sex differences in endocannabinoids during 3 years of Mediterranean diet intervention: Association with insulin resistance and weight loss in a population with metabolic syndrome. Front Nutr. 2022 Dec 1;9:1076677. doi: 10.3389/fnut.2022.1076677. eCollection 2022.
- Background: PubMed 31362802Brennan L, Gibbons H. Sex matters: a focus on the impact of biological sex on metabolomic profiles and dietary interventions. Proc Nutr Soc. 2020 May;79(2):205-209. doi: 10.1017/S002966511900106X. Epub 2019 Jul 31.
- Background: PubMed 20811656Larner J, Brautigan DL, Thorner MO. D-chiro-inositol glycans in insulin signaling and insulin resistance. Mol Med. 2010 Nov-Dec;16(11-12):543-52. doi: 10.2119/molmed.2010.00107. Epub 2010 Aug 27.
- Individual participant dataSharing planned: No
Related trials for Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 2
Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults
Type 2 Diabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
Active, not recruitingPhase 2
Effect of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes.
PreDiabetes, Impaired Glucose Tolerance
Not yet recruitingObservational study
Multimodal Risk Factor Graph Mapping, Metabolic Subtyping, and Digital Intelligent Chronic Disease Management for Prediabetes: An Integrated Cohort and Case-Control Clinical Study
Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
Recruiting
Probiotic Impact on Cognitive Performance, and Metabolic Outcomes in Overweight Young Adults With Impaired Glucose Regulation
Impaired Glucose Regulation, Impaired Glucose Tolerance (Prediabetes)
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 L 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 Plant-based diet in people with Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 11 Dec 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insulin sensitivity (glucose infusion rate) (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 plant-based diet intervention five weeks later.). The study lists 2 primary outcomes in all. 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 NCT06571279, which also lists 10 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 11 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.