Microbiota in Dietary Approach to Obesity
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
KLIINILISES UURINGUS: NCT04453150
BioSeek: nct04453150
Märksõnad
Abstraktne
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: O1: 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, O2: with the metabolic and inflammatory changes, O3: on the cardiovascular system, O4: on the neurocognition, O5: if they are associated to epigenetic changes that may explain the changes found in the other objectives. O6: Determine the safety of the diets that increase the ketone bodies compared to the classic hypocaloric diet, O7: if the effects of the different dietary approaches are maintained during the medium time, and O8: 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).
Kuupäevad
| Viimati kinnitatud: | 02/29/2020 |
| Esmalt esitatud: | 04/16/2020 |
| Hinnanguline registreerumine on esitatud: | 06/25/2020 |
| Esmalt postitatud: | 06/30/2020 |
| Viimane värskendus on esitatud: | 06/25/2020 |
| Viimati värskendus postitatud: | 06/30/2020 |
| Õppe tegelik alguskuupäev: | 01/21/2020 |
| Eeldatav esmane lõpetamise kuupäev: | 05/31/2021 |
| Eeldatav uuringu lõpetamise kuupäev: | 11/30/2021 |
Seisund või haigus
Obesity
Sekkumine / ravi
Other: Standard hypocaloric diet
Other: Intermittent fasting 16/8 (early fasting)
Other: Intermittent fasting 16/8 (late fasting)
Other: Alternate-day fasting
Other: Ketogenic diet
Faas
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Käerühmad
| Arm | Sekkumine / ravi |
|---|---|
| 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 diet 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 |
Abikõlblikkuse kriteeriumid
| Õppimiseks sobivad vanused | 18 Years To 18 Years |
| Uuringuks kõlblikud sood | All |
| Võtab vastu tervislikke vabatahtlikke | Jah |
| Kriteeriumid | 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 |
Tulemus
Esmased tulemusnäitajad
1. 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
Sekundaarsed tulemusmõõdud
1. Weight loss [Baseline, 12 weeks]
To analyze the effect of hypocaloric diets which increase ketone bodies on anthropometric parameters in comparison to a standard hypocaloric diet
2. 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
3. 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
4. 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
5. 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 18F-FDG PET.
6. Changes in 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.
7. 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
8. 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
9. 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
10. 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.
