Microbiota in Dietary Approach to Obesity

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT04453150
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-22
• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-07-01
• Status Verified: 2021-07
• Primary Completion: 2022-06-09
• Study Completion: 2022-06-22
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in gut microbiota composition	Baseline, 12 weeks	To evaluate changes in gut microbiota composition from baseline using different strategies for weight loss which increase ketone bodies in comparison to a standard hypocaloric diet. Change from baseline in 16S rRNA amplicons of fecal community DNA at 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
Changes in body composition.	Baseline, 12 weeks	To analyze the effect of hypocaloric diets which increase ketone bodies on anthropometric parameters in comparison to a standard hypocaloric diet measured by bioelectrical impedance analysis
Changes in uncoupling protein 1 (UCP1)	Baseline, 12 weeks	To analyze the effect of hypocaloric diets which increase ketone bodies on brown adipose tissue UCP1 in comparison to a standard hypocaloric diet using a sample of subcutaneous white adipose tissue assessed by mRNA qPCR.
Changes in blood pressure	Baseline, 12 weeks	To analyze the effect of hypocaloric diets which increase ketone bodies over the cardiovascular system in comparison to a standard hypocaloric diet based on blood pressure
Changes in heart rate	Baseline, 12 weeks	To analyze the effect of hypocaloric diets which increase ketone bodies on heart function measured by heart rate in comparison to a standard hypocaloric diet, measured by Holter.
Changes in weight	Baseline, 12 weeks	To analyze the effect of hypocaloric diets which increase ketone bodies on anthropometric parameters in comparison to a standard hypocaloric diet
Changes in brown adipose tissue.	Baseline, 12 weeks	To analyze the effect of hypocaloric diets which increase ketone bodies on brown adipose tissue in comparison to a standard hypocaloric diet, measured by Positron emission tomography with 18F-fluorodeoxyglucose (18F-FDG PET).
Changes in the punctuation in neurocognitive test	Baseline, 12 weeks	To analyze the effect of hypocaloric diets which increase ketone bodies on neurocognition, in comparison to a standard hypocaloric diet, measured by neurocognitive test
Changes in body mass index.	Baseline, 12 weeks	To analyze the effect of hypocaloric diets which increase ketone bodies on body mass index in comparison to a standard hypocaloric diet
Changes in waist circumference.	Baseline, 12 weeks	To analyze the effect of hypocaloric diets which increase ketone bodies on the waist circumference in comparison to a standard hypocaloric diet
Changes in physical activity.	Baseline, 12 weeks	To analyze the effect of hypocaloric diets which increase ketone bodies on physical activity in comparison to a standard hypocaloric diet measured by accelerometry

Trial Locations

Locations (1)

Virgen de la Victoria Hospital; 🇪🇸 Malaga, Spain