Clinical trial NCT05318898: Effect of Dietary Protein on the Regulation of Exosome microRNA Expression in Patients With Insulin Resistance.
Official title: Effect of Dietary Protein on the Regulation of Exosome microRNA Expression in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the expression profile of microRNAs from exosomes with real -time quantitative polymerase chain reaction in fold change
timeFrame: 4 weeks
Secondary outcomes:
measure: Change on HOMA index
timeFrame: 4 weeks
measure: Change in body weight in kg
timeFrame: 4 weeks
measure: Change in biochemical parameters in mg/dL
timeFrame: 4 weeks
measure: Change in body composition in percentage
timeFrame: 4 weeks
measure: Change in C Reactive Protein in mg/L
timeFrame: 4 weeks
measure: Amino acid profile in mmol/L
timeFrame: 4 weeks
measure: Change in the area under curve of glucose in mg/dL per 2 hours
timeFrame: 4 weeks
measure: Change in the area under curve of insulin in microIU/mL per 2 hours
timeFrame: 4 weeks
measure: Change in the waist circumference in centimeters
timeFrame: 4 weeks
measure: Change in the blood pressure in mmHg
timeFrame: 4 weeks
measure: Change in the Malondialdehyde in micromol/L
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
state: México
city: Mexico City
country: Mexico
facility: Martha Guevara Cruz
Study officials:
affiliation: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran
name: Martha Guevara-Cruz, Doctor
role: PRINCIPAL_INVESTIGATOR
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