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Meal Timing, Genetics and Weight Loss (ONTIME)

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ClinicalTrials.gov Identifier: NCT02829619
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
PROF. MARTA GARAULET AZA, Universidad de Murcia

Brief Summary:
Meal times differ from culture to culture. These differences may influence energy regulation and, consequently, body weight. Current studies support the notion that not only "what" but also "when" the investigators eat may have a significant role in obesity treatment. Recently, it has been shown that eating the main meal of the day, lunch in Spain, late in the day is predictive of difficulty in weight loss and decreased insulin sensitivity. This project aims to study in a Mediterranean population the potential influence of genetics and food timing on obesity, metabolic syndrome and weight loss.

Condition or disease
Obesity

Detailed Description:

Meal times differ from culture to culture. These differences may influence energy regulation and, consequently, body weight. Current studies support the notion that not only "what" but also "when" the investigators eat may have a significant role in obesity treatment. Recently, it has been shown that eating the main meal of the day, lunch in Spain, late in the day is predictive of difficulty in weight loss and decreased insulin sensitivity. Furthermore, it has been shown that eating late at night when plasma melatonin concentrations are elevated, impairs glucose tolerance, particularly in MTNR1B risk allele carriers.

The main objective is to identify the mechanisms underlying the association between the timing of food intake, obesity and metabolic syndrome (MetS) in order to design effective weight loss therapies. The long-term goal is to determine the potential impact of more European, i.e., earlier meal timing on obesity, MetS and weight loss.

The challenge for the society is to develop evidence-based dietary interventions incorporating meal timing and genotype to combat the epidemic of obesity and MetS.

These goals will be achieved through three specific approaches:

  • Epidemiological (observational study) (Aim 1): To assess in an obese population (n=5000) who will follow a weight loss program if clock-related (CLOCK, PER2, CRY, etc.) and melatonin-related variants (MTNR1B) interact with the timing of food intake to determine weight loss effectiveness and MetS features.
  • Interventional (randomized controlled trials) (Aim 2): To determine the internal mechanisms of energy balance and circadian system implicated in the differential effects of food timing (lunch) on weight loss, MetS alterations and the intestinal microbiota (n=25), and to study the potential interaction between meal timing (dinner) and genetic variants MTNR1B for glucose tolerance in obese women (n=100).

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Meal Timing, Genetics and Weight Loss in a Mediterranean Population
Study Start Date : January 2008
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Total weight loss [ Time Frame: weekly, during the 28 weeks of treatment ]
    Body weight will be measured in barefoot wearing light clothes, with a digital scale to the nearest 0.1 kg, at the same time each day.


Secondary Outcome Measures :
  1. Food timing [ Time Frame: at baseline ]
    Timing of breakfast, lunch and dinner

  2. Sleep timing [ Time Frame: at baseline ]
    Habitual sleep timing is estimated using a self-reported questionnaire.

  3. Siesta timing questionnaire [ Time Frame: at baseline ]
    Habitual siesta timing is estimated using a self-reported questionnaire.

  4. Individual chronotype questionnaire [ Time Frame: at baseline ]
    With the Morning and Eveningness Questionnaire (MEQ)

  5. Food habits questionnaire [ Time Frame: at baseline ]
    Variety of food groups is assessed by at 24h recall the day before starting the intervention and by a a seven days dietary record during the intervention. The number of different food items per day will be counted to assess variety of food

  6. Total energy intake dietary questionnaire [ Time Frame: at baseline ]
    by at 24h recall the day before starting the intervention and by a a seven days dietary record during the intervention. Daily energy intake will be calculated

  7. Macronutrient distribution dietary questionnaire [ Time Frame: at baseline ]
    by at 24h recall the day before starting the intervention and by a a seven days dietary record during the intervention. Macronutrient (% from total calories of the diet) and (grams) will be calculated

  8. Glycemic Index questionnaire [ Time Frame: at baseline ]
    by at 24h recall the day before starting the intervention and by a a seven days dietary record during the intervention. The glycemic index will be calculated by using different composition tables

  9. Barriers to Weight Loss checklist [ Time Frame: at baseline ]
    A questionnaire will be complete by the participants. The test consisted of 29 questions classified into seven sections: meal recording; weight control and weekly interviews; eating habits; portion size; food and drink choice; way of eating; and other obstacles to weight loss. There are were three possible responses (never 0, sometimes 1, very often 2) to those questions that represented barriers to losing weight, such as ''Have you lost your motivation?'' or ''Do you have binges?'' Questions that represented aids to weight loss, such as ''Do you accurately measure your portions?'' or ''Is absolutely everything written down?'' applied the same score (0 to 2) but with negative signs. A final ''Barriers to Weight Loss'' score is calculated by adding every answer's score for each patient.

  10. Emotional eating questionnaire [ Time Frame: at baseline ]
    The EEQ (Emotional eating Questionnaire) will be used extent emotions affect eating behaviour. . All the questions had four possible replies: 1) Never, 2) Sometimes; 3) Generally and 4) Always. Each reply was given a score of 1 to 4, the lower the score, the healthier the behaviour. For the clinical practice subjects are classified in four groups attending to the score obtained. Score between 0-5: non-emotional eater. Score between 6-10: low emotional eater. Score between 11-20: emotional eater. Score between 21-30: very emotional eater.

  11. Physical activity questionnaire [ Time Frame: at baseline ]
    by the IPAQ (international Physical Activity Questionnaire)

  12. Mediterranean Diet Score questionnaire [ Time Frame: at baseline ]

    By the questionnaire developed by Antonia Trichopoulou, M.D., Tina Costacou, Ph.D., Christina Bamia, Ph.D., and Dimitrios Trichopoulos, M.D.

    N Engl J Med 2003; 348:2599-2608June 26, 2003DOI: 10.1056/NEJMoa025039


  13. Glucose tolerance [ Time Frame: from 1 year to 3 years after weight loss treatment ]
    either by meal test or by glucose tolerance test

  14. Daily rhythms of wrist temperature [ Time Frame: from 3 months to 3 years after weight loss treatment ]
    7 day-record of wrist temperature by wrist temperature sensors.

  15. Daily rhythms of activity [ Time Frame: from 3 months to 3 years after weight loss treatment ]
    7 day-record of activity by actiwatch

  16. Daily rhythms of autonomus system by ambulatory electrocardiography [ Time Frame: from 3 months to 3 years after weight loss treatment ]
    7 days of ambulatory electrocardiography

  17. Glucose [ Time Frame: at baseline ]
    Fasting glucose

  18. Insulin [ Time Frame: at baseline ]
    Fasting insulin


Biospecimen Retention:   Samples With DNA
whole blood, serum, saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All participants are voluntarily attending five weight loss clinics in Spain for dietetic and behavioral treatment based upon the principles of a Mediterranean diet . All participants are from the Spanish city of Murcia, located on the Southeast coast of the Mediterranean Sea.
Criteria

Inclusion Criteria:

  • Body Mass Index: >25 kg/m2
  • Age: >18 years of age
  • Caucasian

Exclusion Criteria:

  • Receiving treatment with thermogenic, lipogenic, or contraceptive drugs
  • Diabetes mellitus, chronic renal failure, hepatic diseases, or cancer diagnosis
  • bulimia diagnosis, prone to binge eating
  • undergoing treatment with anxiolytic or antidepressant drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829619


Contacts
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Contact: Marta Garaulet, PHD +34-678996368 garaulet@um.es
Contact: Purificacion Gomez-Abellan, PHD +34-968221990 puriki4@hotmail.com

Locations
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Spain
University of Murcia Recruiting
Murcia, Spain, 30100
Contact: Marta Garaulet, PHD    +34678996368    garaulet@um.es   
Sponsors and Collaborators
Universidad de Murcia
Investigators
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Principal Investigator: Marta Garaulet, PHD Universidad de Murcia
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PROF. MARTA GARAULET AZA, Full Professor, Universidad de Murcia
ClinicalTrials.gov Identifier: NCT02829619    
Other Study ID Numbers: R01DK105072-1
R01DK105072 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by PROF. MARTA GARAULET AZA, Universidad de Murcia:
Obesity
Nutrigenetics
Food Timing
Weight loss
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Body Weight Changes