Microbiota in Dietary Approach to Obesity
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Standard hypocaloric diet Mediterranean diet based on olive oil as main fat and regular consumption of vegetables (2 daily rations), fruits 3 daily rations), legumes (3 weekly rations), fish (3 weekly rations), with low consumption of red meat and meat products (less than twice a week), dairy foods (less than once a week) and no sweets, pastries or sugary drinks. Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 45% carbohydrates, 35% fat, 20% protein distributed in at least 4 meals (breakfast, lunch, afternoon snack and dinner). |
Other: Standard hypocaloric die
Standard hypocaloric diet
|
| Experimental: Intermittent fasting 16/8 (early fasting) Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 45% carbohydrates, 35% fat, 20% protein, but it will be consumed for 8 hours a day (from 12 am. to 8 pm.), maintaining 16 fasting hours (from 8 pm. to 12 am. the following day). |
Other: Intermittent fasting 16/8 (early fasting)
Intermittent fasting 16/8 (early fasting)
|
| Experimental: Intermittent fasting 16/8 (late fasting) Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 45% carbohydrates, 35% fat, 20% protein, but it will be consumed for 8 hours a day (from 8 am. to 4 pm.), maintaining 16 fasting hours (from 4 pm. to 8 am. the following day). |
Other: Intermittent fasting 16/8 (late fasting)
Intermittent fasting 16/8 (late fasting)
|
| Experimental: Alternate-day fasting In this diet subjects alternate norm caloric diet during 24 h (according to Harris-Benedict equation) and a diet including only 25% of caloric requirements the following 24 h (this day diet will include 5 % carbohydrates, 65% fat and 30% high biological value protein). |
Other: Alternate-day fasting
Alternate-day fasting
|
| Experimental: Ketogenic diet Diet will produce a 600 kcal per day caloric deficit, according to the Harris-Benedict equation for each subject. Diet will include 5 % carbohydrates, 65% fat and 30% high biological value protein. |
Other: Ketogenic diet
Ketogenic diet
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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 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.
Eligibility Criteria
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.
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Previous or current history of inflammatory disease.
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Active infectious disease.
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The refusal of the patient to participate in the study
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Consumption of probiotics or prebiotics
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Antibiotic therapy in the 3 months prior to the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virgen de la Victoria Hospital | Malaga | Spain | 29010 |
Sponsors and Collaborators
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Investigators
- Principal Investigator: Francisco J. Tinahones, PhD, Instituto de Investigación Biomédica de Málaga (IBIMA).
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ISCIII CP18/01160