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Completed

NCT Number: NCT05318898

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

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico

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About this study

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)

  • Participants will be invited through advertisements.
  • Participants will be corroborated to ensure that they meet the criteria for selection.
  • 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.
  • Anthropometric measurements such as weight, height, blood pressure and body composition will be determined by means of bioelectrical impedance.
  • A 24-hour reminder of food consumption will be made.
  • 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)

  • A medical and nutritional assessment will be performed.
  • The physical activity questionnaire (IPAQ long version) will be administered and participants will be advised not to change their physical activity.
  • Anthropometric and blood pressure measurements will be taken.
  • 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.
  • A blood sample will be obtained to determine plasma exosome microRNA expression and C-reactive protein as a confounding variable for concurrent infection.
  • The patient will be assigned to an intervention group (vegetable protein vs. animal protein) by block randomization.
  • 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.
  • They will be given a logbook to write down their daily food consumption and they will be taught how to fill it out.
  • 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.
  • 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)

  • Consumption logs will be collected.
  • The weekly pantry will be delivered
  • Clarification of doubts

Visit 3 (final)

  • A medical and nutritional assessment will be performed. 2.
  • The physical activity questionnaire (IPAQ long version) will be completed.
  • Anthropometric and blood pressure measurements will be performed.
  • 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.
  • A blood sample will be obtained to determine plasma exosome microRNA expression and C-reactive protein as a confounding variable for concurrent infection.
  • Body temperature will be determined and if female, the date of last menstrual period will be questioned as a confounding variable.
  • The food log will be collected.
  • Clarification of doubts and thanks will be given for their participation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (men and women) between the ages of 18 and 60.
  • Patients with obesity (BMI ≥ 30 and ≤ 50 kg / m2) and with insulin resistance (HOMA - Insulin Resistance Index ≥ 2.5).
  • Signature of letter of consent

Exclusion criteria

  • Patients with any type of diabetes.
  • Patients with kidney disease diagnosed by a medical or with creatinine> 1.3 mg / dL for men and > 1.1 mg / dL for women and / or blood urea nitrogen > 20 mg / dL.
  • Patients with acquired diseases that produce obesity and diabetes secondarily.
  • Patients who have suffered a cardiovascular event.
  • Patients with weight loss > 3 kg in the last 3 months.
  • Patients with any catabolic diseases.
  • Gravidity status
  • Positive smoking and alcoholism
  • Treatment with any medication

Treatment and study plan

Vegetal protein

Other

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

Animal protein

Other

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.

Primary outcomes

  1. Change in the expression profile of microRNAs from exosomes with real -time quantitative polymerase chain reaction in fold change

    Time frame: 4 weeks

    Fold change in the expression profile of microRNAs from exosomes after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) with real -time quantitative polymerase chain reaction

Secondary outcomes

  1. Change on HOMA index

    Time frame: 4 weeks

    Change in the HOMA index after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal).

  2. Change in body weight in kg

    Time frame: 4 weeks

    Change in the body weight in kg after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) using a standard calibrated electronic balance.

  3. Change in biochemical parameters in mg/dL

    Time frame: 4 weeks

    Change the biochemical parameters in mg/dL ( glucose, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol) after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) analysed by an enzymatic colorimetric method using the Cobas C111 analyser (Roche Diagnostic. Indianapolis. IN).

  4. Change in body composition in percentage

    Time frame: 4 weeks

    Change in the body composition in percentage after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) by multifrequency bioimpedance analysis.

  5. Change in C Reactive Protein in mg/L

    Time frame: 4 weeks

    Change in C Reactive Protein in mg/L after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) analysed by an enzymatic colorimetric method using the Cobas C111 analyser (Roche Diagnostic. Indianapolis. IN).

  6. Amino acid profile in mmol/L

    Time frame: 4 weeks

    Change in amino acid profile in mmol/L after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) determinated by High performance liquid chromatography

  7. Change in the area under curve of glucose in mg/dL per 2 hours

    Time frame: 4 weeks

    Change in the area under curve of glucose in mg/dL per 2 hours after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal).

  8. Change in the area under curve of insulin in microIU/mL per 2 hours

    Time frame: 4 weeks

    Change in the area under curve of insulin in micro IU/mL per 2 hours after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal).

  9. Change in the waist circumference in centimeters

    Time frame: 4 weeks

    Change in the waist circumference in centimeters after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) using a flexible tape measure.

  10. Change in the blood pressure in mmHg

    Time frame: 4 weeks

    Change in the blood pressure in mmHg after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal).

  11. Change in the Malondialdehyde in micromol/L

    Time frame: 4 weeks

    Change in the Malondialdehyde in micromol/L after 4 weeks of usual diet with consumption of different protein sources (vegetable vs. animal) measured by ELISA

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2022
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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