CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Standard hypocaloric die +4 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04453150
NCT04453150N/ACompleted

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

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud·interventional·Posted Jul 1, 2020·Updated Jul 6, 2022

In Brief

A clinical study evaluating Standard hypocaloric die, Intermittent fasting 16/8 (early fasting), and 3 other interventions for Obesity. Completed, enrolled 150 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 1, 2020
Enrollment StartJan 22, 2020
Primary CompletionJun 9, 2022
Study CompletionJun 22, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.0 years ago

Interventions

Standard hypocaloric dieother

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 fastingother

Alternate-day fasting

Ketogenic dietother

Ketogenic diet