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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03147703
Other study ID # 2017ES00003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2015
Est. completion date July 31, 2015

Study information

Verified date April 2021
Source Universidad de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this investigation is to test the hypothesis that in humans, eating late may induce changes in saliva microbiota daily rhythms towards a more obesogenic and a less responsiveness to dietary treatments profile. These changes in microbiota may partly explain the weight loss difficulties that characterized late eaters in previous studies. Thus, the aim is to analyze the effect of the timing of food intake in humans' saliva microbiome daily rhythms in a randomized, crossover interventional study, in order to achieve.


Description:

Overweight and obesity can currently be considered a major threat to human health. Recent studies suggest that not only "what" we eat, but also "when" we eat may have a significant role in obesity treatment. The importance of caloric distribution across the day on weight loss therapy was supported by a 12-weeks experimental study showing that subjects assigned to high caloric intake during breakfast lost significantly more weight than those assigned to high caloric intake during the dinner. These results suggest that eating late may affect obesity and impair the success of weight loss therapies. Novel evidence from animal and human studies indicates that the composition of the gut microbiota may also be involved in obesity and weight loss. Moreover, studies performed in extreme obese subjects have demonstrated that weight loss improves the obesity-associated gut microbiota composition towards a lean microbiome phenotype. A recent study has shown that the timing of food intake influences microbiota in mice model. This study reported that obesity dampens the cyclical changes in the gut microbiome of mice while time-restricted feeding (TRF), in which feeding is consolidated to the nocturnal phase, partially restores these cyclical fluctuations. Furthermore, TRF which protects against obesity and metabolic diseases affects bacteria and has shown to influence host metabolism. Then, feeding pattern and time of food intake, in addition to diet, are important parameters when assessing the microbiome's contribution to mice metabolism. However, to our knowledge no human studies are available showing the effect of timing of food intake in microbiota. Thus, the aim was to analyze the effect of the timing of food intake in humans' saliva microbiome, in order to achieve a better understanding of the relationship between food timing, obesity and weight loss in humans. This goal will be achieved through a specific approach: • Interventional (randomized, cross-over controlled trials) (Aim 1): To study that, eating late may induce changes in saliva microbiota daily rhythms towards a more obesogenic pattern and a less responsiveness to dietary treatments profile in women (n=10).


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date July 31, 2015
Est. primary completion date July 1, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 25 Years
Eligibility Inclusion Criteria: - Healthy women - Body Mass Index: 20 to 30 kg/m2 - Caucasian - Day workers Exclusion Criteria: - Endocrine (Diabetes mellitus or others), renal, hepatic, cancer or psychiatric disorders - Receiving any pharmacologic treatment other than oral contraceptives - Bulimia diagnosis, prone to binge eating - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Food Timing
the timing of the main meal of the day (lunch in Spain) is changed from early (14:00) to late (17:30) and viceversa in a randomized and crossover way

Locations

Country Name City State
Spain University of Murcia Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Saliva microbiome daily rhythms Investigators will measure daily rhythms of saliva microbiome at early eating and late eating visits. Total of 4 weeks. Samples will be collected after week 1 and 2 and at week 4.
Primary Feces microbiome daily rhythms Investigators will assess gut microbiome with one feces sample at early eating and late eating visits. Total of 4 weeks. Samples will be collected after week 1 and 2 and at week 4.
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