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Microbiota in Dietary Approach to Obesity

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ClinicalTrials.gov Identifier: NCT04453150
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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: 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).


Condition or disease Intervention/treatment Phase
Obesity Other: Standard hypocaloric die Other: Intermittent fasting 16/8 (early fasting) Other: Intermittent fasting 16/8 (late fasting) Other: Alternate-day fasting Other: Ketogenic diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ketone Bodies and Gut Microbiota Role in the Dietetic Approach of Obesity
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

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




Primary Outcome Measures :
  1. Changes in gut microbiota composition [ Time Frame: 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 :
  1. Weight loss [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04453150


Contacts
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Contact: Francisco J. Tinahones, PhD (+34) 951 440 260 fjtinahones@hotmail.com
Contact: Isabel Moreno-Indias, PhD isabel_moreno_indias@hotmail.com

Locations
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Spain
Virgen de la Victoria Hospital Recruiting
Malaga, Spain, 29010
Contact: Isabel Moreno-Indias, PhD    (+34) 951 440 260    isabel_moreno_indias@hotmail.com   
Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Investigators
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Principal Investigator: Francisco J. Tinahones, PhD Instituto de Investigación Biomédica de Málaga (IBIMA).
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Responsible Party: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT04453150    
Other Study ID Numbers: ISCIII CP18/01160
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:
Ketosis
Microbiota
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms