Clinical trial NCT04453150: Microbiota in Dietary Approach to Obesity
Official title: Ketone Bodies and Gut Microbiota Role in the Dietetic Approach of Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Ketosis
Microbiota
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Changes in gut microbiota composition
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Changes in weight
timeFrame: Baseline, 12 weeks
measure: Changes in body mass index.
timeFrame: Baseline, 12 weeks
measure: Changes in waist circumference.
timeFrame: Baseline, 12 weeks
measure: Changes in body composition.
timeFrame: Baseline, 12 weeks
measure: Changes in brown adipose tissue.
timeFrame: Baseline, 12 weeks
measure: Changes in uncoupling protein 1 (UCP1)
timeFrame: Baseline, 12 weeks
measure: Changes in physical activity.
timeFrame: Baseline, 12 weeks
measure: Changes in blood pressure
timeFrame: Baseline, 12 weeks
measure: Changes in the punctuation in neurocognitive test
timeFrame: Baseline, 12 weeks
measure: Changes in heart rate
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Virgen de la Victoria Hospital
Study officials:
affiliation: Instituto de Investigacion Biomedica de Malaga
name: Francisco J. Tinahones, PhD
role: PRINCIPAL_INVESTIGATOR
References: