NCT04453150

Microbiota in Dietary Approach to Obesity

Ketone Bodies and Gut Microbiota Role in the Dietetic Approach of Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Obesity

Interventions

Type	Name	Description
OTHER	Standard hypocaloric die	Standard hypocaloric diet
OTHER	Intermittent fasting 16/8 (early fasting)	Intermittent fasting 16/8 (early fasting)
OTHER	Intermittent fasting 16/8 (late fasting)	Intermittent fasting 16/8 (late fasting)
OTHER	Alternate-day fasting	Alternate-day fasting
OTHER	Ketogenic diet	Ketogenic diet

Timeline

• Start date: 2020-01-22
• Primary completion: 2022-06-09
• Completion: 2022-06-22
• First posted: 2020-07-01
• Last updated: 2022-07-06

Locations

1 site across 1 country: Spain