Microbiota in Dietary Approach to Obesity

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Status: Completed

Conditions: Obesity

Treatments: Other: Standard hypocaloric die; Other: Intermittent fasting 16/8 (late fasting); Other: Alternate-day fasting; Other: Ketogenic diet; Other: Intermittent fasting 16/8 (early fasting)

Study type: Interventional

Funder types: Other

Identifiers

NCT04453150

ISCIII CP18/01160

Details and patient eligibility

About

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).

Enrollment: 150 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 5 patient groups

Standard hypocaloric diet

Experimental group

Description:

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).

Treatment:

Other: Standard hypocaloric die

Intermittent fasting 16/8 (early fasting)

Experimental group

Description:

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).

Treatment:

Other: Intermittent fasting 16/8 (early fasting)

Intermittent fasting 16/8 (late fasting)

Experimental group

Description:

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).

Treatment:

Other: Intermittent fasting 16/8 (late fasting)

Alternate-day fasting

Experimental group

Description:

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).

Treatment:

Other: Alternate-day fasting

Ketogenic diet

Experimental group

Description:

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.

Treatment:

Other: Ketogenic diet