Timing of Food Intake Impacts Daily Rhythms of Human Saliva Microbiota

NCT03147703 | Completed DMC

• 1 other identifier: 2017ES00003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Women

Keywords

Microbiota; Food timing; Obesity

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Early Eating (EE)

EXPERIMENTAL

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

Behavioral: Food Timing

Late Eating (LE)

EXPERIMENTAL

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

Behavioral: Food Timing

Interventions

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

Early Eating (EE); Late Eating (LE)

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women
• Body Mass Index: 20 to 30 kg/m2
• Caucasian
• Day workers

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

University of Murcia

Murcia, 30100, Spain

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marta Garaulet, PHD

  Universidad de Murcia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full profesor

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 10, 2017
• Study Start: June 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 31, 2015
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)