Obesity
Conditions
Keywords
Ketosis, Microbiota
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).
Interventions
OTHERStandard hypocaloric die
Standard hypocaloric diet
OTHERIntermittent fasting 16/8 (early fasting)
Intermittent fasting 16/8 (early fasting)
OTHERIntermittent fasting 16/8 (late fasting)
Intermittent fasting 16/8 (late fasting)
OTHERAlternate-day fasting
Alternate-day fasting
OTHERKetogenic diet
Ketogenic diet
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 |
| 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 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 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 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. |
Countries
Spain
Outcome results
None listed