Microbiota in Dietary Approach to Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04453150
• Other study ID #: ISCIII CP18/01160
• Status: Completed
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: June 22, 2022

Study information

• Verified date: July 2021
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 22, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
Spain	Virgen de la Victoria Hospital	Malaga

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in gut microbiota composition	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	Baseline, 12 weeks
Secondary	Changes in weight	To analyze the effect of hypocaloric diets which increase ketone bodies on anthropometric parameters in comparison to a standard hypocaloric diet	Baseline, 12 weeks
Secondary	Changes in body mass index.	To analyze the effect of hypocaloric diets which increase ketone bodies on body mass index in comparison to a standard hypocaloric diet	Baseline, 12 weeks
Secondary	Changes in waist circumference.	To analyze the effect of hypocaloric diets which increase ketone bodies on the waist circumference in comparison to a standard hypocaloric diet	Baseline, 12 weeks
Secondary	Changes in body composition.	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	Baseline, 12 weeks
Secondary	Changes in brown adipose tissue.	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).	Baseline, 12 weeks
Secondary	Changes in uncoupling protein 1 (UCP1)	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.	Baseline, 12 weeks
Secondary	Changes in physical activity.	To analyze the effect of hypocaloric diets which increase ketone bodies on physical activity in comparison to a standard hypocaloric diet measured by accelerometry	Baseline, 12 weeks
Secondary	Changes in blood pressure	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	Baseline, 12 weeks
Secondary	Changes in the punctuation in neurocognitive test	To analyze the effect of hypocaloric diets which increase ketone bodies on neurocognition, in comparison to a standard hypocaloric diet, measured by neurocognitive test	Baseline, 12 weeks
Secondary	Changes in heart rate	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.	Baseline, 12 weeks