Timing of Food Intake Impacts Daily Rhythms of Human Saliva Microbiota (ONTIME-MIC)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Women
• Intervention / Treatment: Behavioral: Food Timing

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).

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30100
    • University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Eating (EE); The intervention is Food Timing, Early Eating is defined at 13:00 hours for lunch	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
Experimental: Late Eating (LE); The intervention is Food Timing, Late Eating is defined for 17:30 hours for lunch	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Universidad de Murcia
• Investigators: Study Director: Marta Garaulet, PHD, Universidad de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 31, 2015

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: May 7, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Microbiota; Food timing
• Other Study ID Numbers: 2017ES00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Spain: Ministry of Health and consumption

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No