NCT05318898

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

Completed NA Last updated 27 January 2025

What this trial tests

NA trial testing Vegetal protein in Insulin Resistance in 40 participants. Completed in 10 September 2024.

Timeline

15 September 2023

Primary endpoint
1 March 2024

10 September 2024

Quick facts

Lead sponsor	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	15 September 2023
Primary completion	1 March 2024
Estimated completion	10 September 2024
Sites	2 locations across Mexico

Drugs / interventions tested

• Vegetal protein
• Animal protein

Conditions studied

• Insulin Resistance — all drugs for Insulin Resistance →

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — full company profile →

Who can join

Adults 18 to 60, any sex, with Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Plant-Derived Exosome-Like Nanovesicles: Current Progress and Prospects.
   Mu N, Li J, Zeng L, You J, et al · · 2023 · cited 113× · PMID 37693885 · DOI 10.2147/ijn.s420748
2. Insight into the Functional Dynamics and Challenges of Exosomes in Pharmaceutical Innovation and Precision Medicine.
   Sharma A, Yadav A, Nandy A, Ghatak S. · · 2024 · cited 40× · PMID 38931833 · DOI 10.3390/pharmaceutics16060709