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Completed

NCT Number: NCT03147703

Timing of Food Intake Impacts Daily Rhythms of Human Saliva Microbiota

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.

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Key information

Age range

20 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Murcia

Murcia, 30100, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Food Timing

Behavioral

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

Primary outcomes

  1. Saliva microbiome daily rhythms

    Time frame: Total of 4 weeks. Samples will be collected after week 1 and 2 and at week 4.

    Investigators will measure daily rhythms of saliva microbiome at early eating and late eating visits.

  2. Feces microbiome daily rhythms

    Time frame: Total of 4 weeks. Samples will be collected after week 1 and 2 and at week 4.

    Investigators will assess gut microbiome with one feces sample at early eating and late eating visits.

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

Timing of Food Intake Impacts Daily Rhythms of Human Saliva Microbiota in a Mediterranean Population

Acronym: ONTIME-MIC

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 10, 2017
Registry last updated
Apr 22, 2021

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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