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Insulin ResistanceNCT05318898

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

A study testing Vegetal protein and Animal protein in people with Insulin Resistance, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 2 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Insulin Resistance
What is being tested?
Vegetal protein and Animal protein
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesMexico
Study dates
15 Sep 2023to 10 Sep 2024
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • Gravidity status
  • Positive smoking and alcoholism
  • Treatment with any medication

Trial locations and contacts

2 sites in 1 country.

Mexico2 sites

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

    Mexico City, Mexico City, 14080

  • Martha Guevara Cruz

    Mexico City, 14060

Other trials in Mexico

About this study

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

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.

Read the 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.
  8. They will be given a logbook to write down their daily food consumption and they will be taught how to fill it out.
  9. 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.
  10. 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.
Being tested
Vegetal protein, Animal protein
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vegetal proteinOther

    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 proteinOther

    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.

Study groups in NCT05318898
Study groupRoleWhat they receive
Regular diet with vegetable proteinExperimentalNutritional recommendations will be given to ensure that the patient consumes a regular diet where the protein intake will be mostly from vegetable protein sources.
Receives: Other: Vegetal protein
Regular diet with animal proteinActive comparatorNutritional recommendations will be given to ensure that the patient consumes a regular diet where the protein intake will be mostly from animal protein sources.
Receives: Other: Animal protein

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: 4 weeks

Secondary outcomes (11)

  1. Change on HOMA index

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

    Measured: 4 weeks

  2. Change in body weight in kg

    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.

    Measured: 4 weeks

  3. Change in biochemical parameters in mg/dL

    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).

    Measured: 4 weeks

  4. Change in body composition in percentage

    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.

    Measured: 4 weeks

  5. Change in C Reactive Protein in mg/L

    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).

    Measured: 4 weeks

  6. Amino acid profile in mmol/L

    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

    Measured: 4 weeks

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

    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).

    Measured: 4 weeks

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

    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).

    Measured: 4 weeks

  9. Change in the waist circumference in centimeters

    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.

    Measured: 4 weeks

  10. Change in the blood pressure in mmHg

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

    Measured: 4 weeks

  11. Change in the Malondialdehyde in micromol/L

    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

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2022
  2. Study start15 Sep 2023
  3. Primary completion1 Mar 2024
  4. Study completion10 Sep 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05318898
Sponsor's protocol ID
3986-22-22-1
Status last verified
Jan 2025
First submitted
24 Mar 2022
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lasser C. Mapping Extracellular RNA Sheds Lights on Distinct Carriers. Cell. 2019 Apr 4;177(2):228-230. doi: 10.1016/j.cell.2019.03.027.

    PubMed 30951666

  • Mori MA, Ludwig RG, Garcia-Martin R, Brandao BB, Kahn CR. Extracellular miRNAs: From Biomarkers to Mediators of Physiology and Disease. Cell Metab. 2019 Oct 1;30(4):656-673. doi: 10.1016/j.cmet.2019.07.011. Epub 2019 Aug 22.

    PubMed 31447320

  • Safdar A, Tarnopolsky MA. Exosomes as Mediators of the Systemic Adaptations to Endurance Exercise. Cold Spring Harb Perspect Med. 2018 Mar 1;8(3):a029827. doi: 10.1101/cshperspect.a029827.

    PubMed 28490541

  • Huang Y, Yan Y, Xv W, Qian G, Li C, Zou H, Li Y. A New Insight into the Roles of MiRNAs in Metabolic Syndrome. Biomed Res Int. 2018 Dec 17;2018:7372636. doi: 10.1155/2018/7372636. eCollection 2018.

    PubMed 30648107

  • Castano C, Kalko S, Novials A, Parrizas M. Obesity-associated exosomal miRNAs modulate glucose and lipid metabolism in mice. Proc Natl Acad Sci U S A. 2018 Nov 27;115(48):12158-12163. doi: 10.1073/pnas.1808855115. Epub 2018 Nov 14.

    PubMed 30429322

  • Jimenez-Lucena R, Alcala-Diaz JF, Roncero-Ramos I, Lopez-Moreno J, Camargo A, Gomez-Delgado F, Quintana-Navarro GM, Vals-Delgado C, Rodriguez-Cantalejo F, Luque RM, Delgado-Lista J, Ordovas JM, Perez-Martinez P, Rangel-Zuniga OA, Lopez-Miranda J. MiRNAs profile as biomarkers of nutritional therapy for the prevention of type 2 diabetes mellitus: From the CORDIOPREV study. Clin Nutr. 2021 Mar;40(3):1028-1038. doi: 10.1016/j.clnu.2020.06.035. Epub 2020 Jul 15.

    PubMed 32723508

  • Min KH, Yang WM, Lee W. Saturated fatty acids-induced miR-424-5p aggravates insulin resistance via targeting insulin receptor in hepatocytes. Biochem Biophys Res Commun. 2018 Sep 10;503(3):1587-1593. doi: 10.1016/j.bbrc.2018.07.084. Epub 2018 Jul 20.

    PubMed 30033101

Questions about this trial

What is this clinical trial studying?

A study testing Vegetal protein and Animal protein in people with Insulin Resistance, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 2 sites in Mexico.

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 3 inclusion and 9 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 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mexico. 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?

Change in the expression profile of microRNAs from exosomes with real -time quantitative polymerase chain reaction in fold change (time frame: 4 weeks). 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 NCT05318898, which also lists 7 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 27 Jan 2025.

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