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Completed

NCT Number: NCT04453150

Microbiota in Dietary Approach to Obesity

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).

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Key information

Conditions

Obesity Acid-Base Imbalance Acidosis Body Weight Ketosis Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virgen de la Victoria Hospital

Málaga, 29010, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard hypocaloric die

Other

Standard hypocaloric diet

Intermittent fasting 16/8 (early fasting)

Other

Intermittent fasting 16/8 (early fasting)

Intermittent fasting 16/8 (late fasting)

Other

Intermittent fasting 16/8 (late fasting)

Alternate-day fasting

Other

Alternate-day fasting

Ketogenic diet

Other

Ketogenic diet

Primary outcomes

  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 outcomes

  1. Changes in weight

    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 Positron emission tomography with 18F-fluorodeoxyglucose (18F-FDG PET).

  6. Changes in uncoupling protein 1 (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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 1, 2020
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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