Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant-based diet | Other | 5 weeks of plant-based meals and snacks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant-based diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Since sex hormones may play a role in diet response, prospective participants taking a medication that significantly affects sex hormones (like estrogen or testosterone) will not be eligible to participate.
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean L Fry, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky CCTS | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22221517 | Background | 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. | |
| 29948369 | Background | Chen 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D007333 | Insulin Resistance |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Absolute change in visceral fat (g) | Computed tomography will be used to measure visceral fat | 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 | 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. |
| 18356403 | Background | Perreault 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. |
| 25416917 | Background | Leblanc 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. |
| 15800559 | Background | Sargrad 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. |
| 24595221 | Background | Bedard 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. |
| 29980312 | Background | Minambres 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. |
| 36532543 | Background | Soldevila-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. |
| 31362802 | Background | Brennan 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. |
| 20811656 | Background | Larner 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. |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D006943 | Hyperglycemia |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |