Timing of Food Intake Impacts Daily Rhythms of Human Saliva Microbiota

NCT ID: NCT03147703

Last Updated: 2021-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2015-07-31

Brief 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.

Detailed 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).

Conditions

Healthy Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Early Eating (EE)

The intervention is Food Timing, Early Eating is defined at 13:00 hours for lunch

Group Type: EXPERIMENTAL

Food Timing

Intervention Type: 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

Late Eating (LE)

The intervention is Food Timing, Late Eating is defined for 17:30 hours for lunch

Group Type: EXPERIMENTAL

Food Timing

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Murcia

OTHER

Sponsor Role: lead

Responsible Party

PROF. MARTA GARAULET AZA

Full profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marta Garaulet, PHD

Role: STUDY_DIRECTOR

Universidad de Murcia

Locations

University of Murcia

Murcia, , Spain

Countries

Spain

Other Identifiers

2017ES00003

Identifier Type: -

Identifier Source: org_study_id