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
|Condition or disease|
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).
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|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|
- 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.
- Food timing [ Time Frame: at baseline ]Timing of breakfast, lunch and dinner
- Sleep timing [ Time Frame: at baseline ]Habitual sleep timing is estimated using a self-reported questionnaire.
- Siesta timing questionnaire [ Time Frame: at baseline ]Habitual siesta timing is estimated using a self-reported questionnaire.
- Individual chronotype questionnaire [ Time Frame: at baseline ]With the Morning and Eveningness Questionnaire (MEQ)
- 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
- 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
- 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
- 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
- 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.
- 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.
- Physical activity questionnaire [ Time Frame: at baseline ]by the IPAQ (international Physical Activity Questionnaire)
- 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
- Glucose tolerance [ Time Frame: from 1 year to 3 years after weight loss treatment ]either by meal test or by glucose tolerance test
- 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.
- Daily rhythms of activity [ Time Frame: from 3 months to 3 years after weight loss treatment ]7 day-record of activity by actiwatch
- 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
- Glucose [ Time Frame: at baseline ]Fasting glucose
- Insulin [ Time Frame: at baseline ]Fasting insulin
Biospecimen Retention: Samples With DNA
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
|Contact: Marta Garaulet, PHDfirstname.lastname@example.org|
|Contact: Purificacion Gomez-Abellan, PHDemail@example.com|
|University of Murcia||Recruiting|
|Murcia, Spain, 30100|
|Contact: Marta Garaulet, PHD +34678996368 firstname.lastname@example.org|
|Principal Investigator:||Marta Garaulet, PHD||Universidad de Murcia|