NCT05318898

Effect of Dietary Protein on the Regulation of Exosome microRNA Expression in Patients With Insulin Resistance.

Effect of Dietary Protein on the Regulation of Exosome microRNA Expression in Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

miRNAs are small non-coding RNAs of approximately 22 nucleotides in length, which have the function of regulating gene expression at the post-transcriptional level through base complementation of protein-coding transcripts, this interaction leading to translational repression by destabilizing the messenger RNA. Evidence demonstrates an association between differences in miRNA expression and the development of various pathologies, including obesity, type 2 diabetes, cardiovascular disease, neurodegenerative disorders and cancer. Other factors that could also modulate miRNA expression include nutritional status, diet and even exercise. The aim of this study is to identify exosome microRNAs that modify their expression in plasma from patients with insulin resistance fed different dietary protein sources. A randomized controlled clinical trial will be performed where the selected participants will be assigned by lottery to a dietary intervention of usual diet with protein of plant or animal origin for 4 weeks. The study will consist of 3 visits where anthropometric parameters, body composition, systolic and diastolic blood pressure, dietary compliance through 24-hour recall and food logs, biochemical tests (insulin, glucose, triglycerides, total cholesterol, HDL, LDL), the relative expression of plasma exosome miRNAs and markers of oxidative stress will be evaluated. Participants will receive a weekly food pantry during the first two visits in order to improve compliance to the dietary intervention.

Detailed description

The study will evaluate the effect of 2 dietary interventions on the regulation of plasma exosome microRNA expression in patients with insulin resistance. STUDY PROGRAM The study will consist of 3 visits Planned (selection of participants) 1. Participants will be invited through advertisements. 2. Participants will be corroborated to ensure that they meet the criteria for selection. 3. If they are candidates for the protocol, participants will be provided with the letter of consent to read carefully and any doubts that may arise will be resolved. Participants will be informed about the characteristics of the study as well as the expected risks and benefits. If they agree, the participant will be asked to sign the consent form. 4. Anthropometric measurements such as weight, height, blood pressure and body composition will be determined by means of bioelectrical impedance. 5. A 24-hour reminder of food consumption will be made. 6. A whole blood sample will be taken for glucose and insulin determination, in order to determine the HOMA-Insulin Resistance index. Once the insulin resistance patients are identified (HOMA- Insulin Resistance ≥ 2.5) the study will begin and participants will be randomized into two intervention groups. Visit 1 (baseline) 1. A medical and nutritional assessment will be performed. 2. The physical activity questionnaire (IPAQ long version) will be administered and participants will be advised not to change their physical activity. 3. Anthropometric and blood pressure measurements will be taken. 4. Oral glucose tolerance test will be performed for 2 hours after a 12-hour fast to determine the area under the insulin and glucose curve and determination of insulinemic and glycemic indices. 5. A blood sample will be obtained to determine plasma exosome microRNA expression and C-reactive protein as a confounding variable for concurrent infection. 6. The patient will be assigned to an intervention group (vegetable protein vs. animal protein) by block randomization. 7. The participants will continue their usual diet, And the consumption of animal protein or the consumption of vegetable protein will be recommended, according to the assigned group. They will be given and explained a list of foods that provide proteins of animal and vegetable origin, which they could integrate into their usual diet, these lists will indicate which foods to consume and which not to consume, according to the intervention group to which they were assigned. 9\. They will be given a logbook to write down their daily food consumption and they will be taught how to fill it out. 10\. An online questionnaire will be explained how to fill out every third day to detect the consumption of recommended and non-recommended foods from the list provided, according to the assigned group. 11\. They will be given a pantry with foods rich in protein only (animal protein vs. vegetable protein) according to the assigned group (explained in the section on pantries). Visit 2 (intermediate) 1. Consumption logs will be collected. 2. The weekly pantry will be delivered 3. Clarification of doubts Visit 3 (final) 1. A medical and nutritional assessment will be performed. 2. 2. The physical activity questionnaire (IPAQ long version) will be completed. 3. Anthropometric and blood pressure measurements will be performed. 4. Oral glucose tolerance test will be performed for 2 hours after a 12 hour fast to determine the area under the insulin and glucose curve and determination of insulinemic and glycemic indices. 5. A blood sample will be obtained to determine plasma exosome microRNA expression and C-reactive protein as a confounding variable for concurrent infection. 6. Body temperature will be determined and if female, the date of last menstrual period will be questioned as a confounding variable. 7. The food log will be collected. 8. Clarification of doubts and thanks will be given for their participation.

Conditions

• Insulin Resistance

Interventions

Type	Name	Description
OTHER	Vegetal protein	Nutritional recommendations will be given to ensure that the patient consumes a regular diet where the protein intake will be mostly from vegetal protein sources
OTHER	Animal protein	Nutritional recommendations will be given to ensure that the patient consumes a regular diet where the protein intake will be mostly from animal protein sources.

Timeline

• Start date: 2023-09-15
• Primary completion: 2024-03-01
• Completion: 2024-09-10
• First posted: 2022-04-08
• Last updated: 2025-01-27

Locations

2 sites across 1 country: Mexico