Microbiota in Dietary Approach to Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2022-06-22

Brief Summary

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Main aim: Study the anthropometric, metabolic, cardiovascular and neurocognitive and gut microbiota changes of different approaches for the weight reduction that increase the ketone bodies in a different proportion in relation to the classic hypocaloric diet.

Objective 1: Study the effect of hypocaloric diets that increase the ketone bodies on gut microbiota and its relationship with anthropometric changes and of the Brown adipose tissue, Objective 2: with the metabolic and inflammatory changes, Objective 3: on the cardiovascular system, Objective 4: on the neurocognition, Objective 5: if they are associated to epigenetic changes that may explain the changes found in the other objectives. Objective 6: Determine the safety of the diets that increase the ketone bodies compared to the classic hypocaloric diet, Objective 7: if the effects of the different dietary approaches are maintained during the medium time, and Objective 8: Verify in experimental models (microbiota transplants from humans with different diets to germ-free mice, ketosis dietary models, and ketone bodies administration) the causality of the gut microbiota of these findings.

Methodology: Model 1: Dietary intervention in humans with 4 types of diet with a different increase of the ketone bodies: classic hypocaloric diet (DH); diet with 8h of feeding and 16h of starving in periods of 24h (D16); diet with intermittent caloric restriction (DA); and normal in protein and low in carbohydrates hypocaloric ketogenic diet (DC).

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard hypocaloric diet

Mediterranean diet based on olive oil as main fat and regular consumption of vegetables (2 daily rations), fruits 3 daily rations), legumes (3 weekly rations), fish (3 weekly rations), with low consumption of red meat and meat products (less than twice a week), dairy foods (less than once a week) and no sweets, pastries or sugary drinks. Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 45% carbohydrates, 35% fat, 20% protein distributed in at least 4 meals (breakfast, lunch, afternoon snack and dinner).

Group Type EXPERIMENTAL

Standard hypocaloric die

Intervention Type OTHER

Standard hypocaloric diet

Intermittent fasting 16/8 (early fasting)

Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 45% carbohydrates, 35% fat, 20% protein, but it will be consumed for 8 hours a day (from 12 am. to 8 pm.), maintaining 16 fasting hours (from 8 pm. to 12 am. the following day).

Group Type EXPERIMENTAL

Intermittent fasting 16/8 (early fasting)

Intervention Type OTHER

Intermittent fasting 16/8 (early fasting)

Intermittent fasting 16/8 (late fasting)

Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 45% carbohydrates, 35% fat, 20% protein, but it will be consumed for 8 hours a day (from 8 am. to 4 pm.), maintaining 16 fasting hours (from 4 pm. to 8 am. the following day).

Group Type EXPERIMENTAL

Intermittent fasting 16/8 (late fasting)

Intervention Type OTHER

Intermittent fasting 16/8 (late fasting)

Alternate-day fasting

In this diet subjects alternate norm caloric diet during 24 h (according to Harris-Benedict equation) and a diet including only 25% of caloric requirements the following 24 h (this day diet will include 5 % carbohydrates, 65% fat and 30% high biological value protein).

Group Type EXPERIMENTAL

Alternate-day fasting

Intervention Type OTHER

Alternate-day fasting

Ketogenic diet

Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 5 % carbohydrates, 65% fat and 30% high biological value protein.

Group Type EXPERIMENTAL

Ketogenic diet

Intervention Type OTHER

Ketogenic diet

Interventions

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Standard hypocaloric die

Standard hypocaloric diet

Intervention Type OTHER

Intermittent fasting 16/8 (early fasting)

Intervention Type OTHER

Intermittent fasting 16/8 (late fasting)

Intervention Type OTHER

Alternate-day fasting

Intervention Type OTHER

Ketogenic diet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Obesity (BMI≥30-45 kg/m2)

Exclusion Criteria

* Type 2 diabetes mellitus
* Patients with major cardiovascular events in the 6 months prior to the study beginning.
* Previous or current history of inflammatory disease.
* Active infectious disease.
* The refusal of the patient to participate in the study
* Consumption of probiotics or prebiotics
* Antibiotic therapy in the 3 months prior to the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes