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Meal Timing, Genetics and Weight Loss

Meal Timing, Genetics and Weight Loss in a Mediterranean Population

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02829619
Acronym
ONTIME
Enrollment
5788
Registered
2016-07-12
Start date
2008-01-01
Completion date
2032-06-01
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Nutrigenetics, Food Timing, Weight loss

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.

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). Prospective Follow-up (Long-term Assessment): We will recontact all individuals who previously participated in the ONTIME study and completed a weight-loss program at nutritional clinics at least four years ago (n=5603), aiming to achieve a final sample of approximately 500 participants. Participants will attend the nutritional clinic, where body weight, height, waist and hip circumference, and total body fat will be assessed using standardized methods. Blood samples will be collected for biochemical and genetic analyses. On the first day, participants will complete questionnaires on medical history, emotional eating, environmental factors, chronotype, sleep, physical activity, and dietary intake. All variables measured are the same as those assessed at the start of the study. Additionally, for seven consecutive days, participants will record their food intake, physical activity, and sleep using a mobile application. From this population, a subpopulation of 200 participants will undergo ambulatory ECG for three days and seven-day actigraphy and temperature monitoring using Kronosensor and a light pendant. This follow-up will allow the assessment of long-term weight loss maintenance, behavioral timing, and physiological markers several years after the initial intervention.

Interventions

None listed

Sponsors

Universidad de Murcia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Total weight lossweekly, during the 28 weeks of treatmentBody 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.
Long term weight loss maintenanceonce at least one year after ending the treatmentBody weight will be measured in barefoot wearing light clothes, with a digital scale to the nearest 0.1 kg.

Secondary

MeasureTime frameDescription
Food timingat baselineTiming of breakfast, lunch and dinner
Sleep timingat baselineHabitual sleep timing is estimated using a self-reported questionnaire.
Siesta timing questionnaireat baselineHabitual siesta timing is estimated using a self-reported questionnaire.
Individual chronotype questionnaireat baselineWith the Morning and Eveningness Questionnaire (MEQ)
Food habits questionnaireat baselineVariety 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 questionnaireat baselineby 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 questionnaireat baselineby 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 questionnaireat baselineby 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 checklistat baselineA 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 questionnaireat baselineThe 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 questionnaireat baselineby the IPAQ (international Physical Activity Questionnaire)
Mediterranean Diet Score questionnaireat baselineBy 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 tolerancefrom 1 year to 3 years after weight loss treatmenteither by meal test or by glucose tolerance test
Daily rhythms of wrist temperaturefrom 3 months to 3 years after weight loss treatment7 day-record of wrist temperature by wrist temperature sensors.
Daily rhythms of activityfrom 3 months to 3 years after weight loss treatment7 day-record of activity by actiwatch
Daily rhythms of autonomus system by ambulatory electrocardiographyfrom 3 months to 3 years after weight loss treatment7 days of ambulatory electrocardiography
Glucoseat baselineFasting glucose
Insulinat baselineFasting insulin

Countries

Spain

Contacts

CONTACTMarta Garaulet, PHD
garaulet@um.es+34-678996368
CONTACTPurificacion Gomez-Abellan, PHD
puriki4@hotmail.com+34-968221990
PRINCIPAL_INVESTIGATORMarta Garaulet, PHD

Universidad de Murcia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026