ObesityONTIMENCT02829619
Meal Timing, Genetics and Weight Loss
An observational study of Obesity, run by Universidad de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 5,788 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2008to Jun 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Body Mass Index: >25 kg/m2
- Age: >18 years of age
- Caucasian
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Murcia
Murcia, Murcia, 30100
Marta Garaulet, PHD, +34678996368, garaulet@um.es
About this study
Official title: Meal Timing, Genetics and Weight Loss in a Mediterranean Population
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.
Read the 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.
- Conditions
- Obesity
- Keywords
- Obesity, Nutrigenetics, Food Timing, Weight loss
- Medical subject headings
- Obesity, Weight Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Total weight loss
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.
Measured: weekly, during the 28 weeks of treatment
Long term weight loss maintenance
Body weight will be measured in barefoot wearing light clothes, with a digital scale to the nearest 0.1 kg.
Measured: once at least one year after ending the treatment
Secondary outcomes (18)
Food timing
Timing of breakfast, lunch and dinner
Measured: at baseline
Sleep timing
Habitual sleep timing is estimated using a self-reported questionnaire.
Measured: at baseline
Siesta timing questionnaire
Habitual siesta timing is estimated using a self-reported questionnaire.
Measured: at baseline
Individual chronotype questionnaire
With the Morning and Eveningness Questionnaire (MEQ)
Measured: at baseline
Food habits questionnaire
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
Measured: at baseline
Total energy intake dietary questionnaire
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
Measured: at baseline
Macronutrient distribution dietary questionnaire
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
Measured: at baseline
Glycemic Index questionnaire
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
Measured: at baseline
Barriers to Weight Loss checklist
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.
Measured: at baseline
Emotional eating questionnaire
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.
Measured: at baseline
Physical activity questionnaire
by the IPAQ (international Physical Activity Questionnaire)
Measured: at baseline
Mediterranean Diet Score questionnaire
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
Measured: at baseline
Glucose tolerance
either by meal test or by glucose tolerance test
Measured: from 1 year to 3 years after weight loss treatment
Daily rhythms of wrist temperature
7 day-record of wrist temperature by wrist temperature sensors.
Measured: from 3 months to 3 years after weight loss treatment
Daily rhythms of activity
7 day-record of activity by actiwatch
Measured: from 3 months to 3 years after weight loss treatment
Daily rhythms of autonomus system by ambulatory electrocardiography
7 days of ambulatory electrocardiography
Measured: from 3 months to 3 years after weight loss treatment
Glucose
Fasting glucose
Measured: at baseline
Insulin
Fasting insulin
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start1 Jan 2008
- Primary completionJun 2027 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,788 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PROF. MARTA GARAULET AZA, Universidad de Murcia
- Investigators
- Marta Garaulet, PHD, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829619
- Sponsor's protocol ID
- R01DK105072-1
- Other IDs
- R01DK105072
- Acronym
- ONTIME
- Status last verified
- May 2024
- First submitted
- 10 Jun 2016
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Garaulet M, Vera B, Bonnet-Rubio G, Gomez-Abellan P, Lee YC, Ordovas JM. Lunch eating predicts weight-loss effectiveness in carriers of the common allele at PERILIPIN1: the ONTIME (Obesity, Nutrigenetics, Timing, Mediterranean) study. Am J Clin Nutr. 2016 Oct;104(4):1160-1166. doi: 10.3945/ajcn.116.134528. Epub 2016 Sep 14.
PubMed 27629052Gomez-Santos C, Saura CB, Lucas JA, Castell P, Madrid JA, Garaulet M. Menopause status is associated with circadian- and sleep-related alterations. Menopause. 2016 Jun;23(6):682-90. doi: 10.1097/GME.0000000000000612.
PubMed 27093617Corbalan-Tutau MD, Gomez-Abellan P, Madrid JA, Canteras M, Ordovas JM, Garaulet M. Toward a chronobiological characterization of obesity and metabolic syndrome in clinical practice. Clin Nutr. 2015 Jun;34(3):477-83. doi: 10.1016/j.clnu.2014.05.007. Epub 2014 May 28.
PubMed 24953771Lopez-Guimera G, Dashti HS, Smith CE, Sanchez-Carracedo D, Ordovas JM, Garaulet M. CLOCK 3111 T/C SNP interacts with emotional eating behavior for weight-loss in a Mediterranean population. PLoS One. 2014 Jun 6;9(6):e99152. doi: 10.1371/journal.pone.0099152. eCollection 2014.
PubMed 24905098Dashti HS, Smith CE, Lee YC, Parnell LD, Lai CQ, Arnett DK, Ordovas JM, Garaulet M. CRY1 circadian gene variant interacts with carbohydrate intake for insulin resistance in two independent populations: Mediterranean and North American. Chronobiol Int. 2014 Jun;31(5):660-7. doi: 10.3109/07420528.2014.886587. Epub 2014 Feb 18.
PubMed 24548145Bandin C, Martinez-Nicolas A, Ordovas JM, Madrid JA, Garaulet M. Circadian rhythmicity as a predictor of weight-loss effectiveness. Int J Obes (Lond). 2014 Aug;38(8):1083-8. doi: 10.1038/ijo.2013.211. Epub 2013 Nov 15.
PubMed 24232497Garaulet M, Smith CE, Gomez-Abellan P, Ordovas-Montanes M, Lee YC, Parnell LD, Arnett DK, Ordovas JM. REV-ERB-ALPHA circadian gene variant associates with obesity in two independent populations: Mediterranean and North American. Mol Nutr Food Res. 2014 Apr;58(4):821-9. doi: 10.1002/mnfr.201300361. Epub 2013 Oct 31.
PubMed 24173768Garaulet M, Gomez-Abellan P. Chronobiology and obesity. Nutr Hosp. 2013 Sep;28 Suppl 5:114-20. doi: 10.3305/nh.2013.28.sup5.6926.
PubMed 24010751Morales-Falo EM, Sanchez-Moreno C, Esteban A, Alburquerque JJ, Garaulet M. [Quality of the diet "before and during" a weight loss treatment based on Mediterranean Diet; behavioural therapy and nutritional education]. Nutr Hosp. 2013 Jul-Aug;28(4):980-7. doi: 10.3305/nh.2013.28.4.6665. Spanish.
PubMed 23889612Garaulet M, Gomez-Abellan P, Alburquerque-Bejar JJ, Lee YC, Ordovas JM, Scheer FA. Timing of food intake predicts weight loss effectiveness. Int J Obes (Lond). 2013 Apr;37(4):604-11. doi: 10.1038/ijo.2012.229. Epub 2013 Jan 29.
PubMed 23357955Bandin C, Martinez-Nicolas A, Ordovas JM, Ros Lucas JA, Castell P, Silvente T, Madrid JA, Garaulet M. Differences in circadian rhythmicity in CLOCK 3111T/C genetic variants in moderate obese women as assessed by thermometry, actimetry and body position. Int J Obes (Lond). 2013 Aug;37(8):1044-50. doi: 10.1038/ijo.2012.180. Epub 2012 Nov 20.
PubMed 23183326Milagro FI, Gomez-Abellan P, Campion J, Martinez JA, Ordovas JM, Garaulet M. CLOCK, PER2 and BMAL1 DNA methylation: association with obesity and metabolic syndrome characteristics and monounsaturated fat intake. Chronobiol Int. 2012 Nov;29(9):1180-94. doi: 10.3109/07420528.2012.719967. Epub 2012 Sep 24.
PubMed 23003921Garaulet M, Canteras M, Morales E, Lopez-Guimera G, Sanchez-Carracedo D, Corbalan-Tutau MD. Validation of a questionnaire on emotional eating for use in cases of obesity: the Emotional Eater Questionnaire (EEQ). Nutr Hosp. 2012 Mar-Apr;27(2):645-51. doi: 10.1590/S0212-16112012000200043.
PubMed 22732995Corbalan-Tutau D, Madrid JA, Nicolas F, Garaulet M. Daily profile in two circadian markers "melatonin and cortisol" and associations with metabolic syndrome components. Physiol Behav. 2014 Jan 17;123:231-5. doi: 10.1016/j.physbeh.2012.06.005. Epub 2012 Jun 15.
PubMed 22705307Corbalan-Tutau MD, Madrid JA, Garaulet M. Timing and duration of sleep and meals in obese and normal weight women. Association with increase blood pressure. Appetite. 2012 Aug;59(1):9-16. doi: 10.1016/j.appet.2012.03.015. Epub 2012 Mar 23.
PubMed 22450522
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meal Timing, Genetics and Weight Loss in a Mediterranean Population
- ClinicalTrials.gov ID
- NCT02829619
- Acronym / sponsor ID
- ONTIME / R01DK105072-1
- Conditions
- Obesity
- Keywords
- Obesity, Nutrigenetics, Food Timing, Weight loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,788 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Body Mass Index: >25 kg/m2
- Age: >18 years of age
- Caucasian
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Long term weight loss maintenance
Time frame: once at least one year after ending the treatment
Body weight will be measured in barefoot wearing light clothes, with a digital scale to the nearest 0.1 kg.
18 secondary outcomes
Food timing
Time frame: at baseline
Sleep timing
Time frame: at baseline
Siesta timing questionnaire
Time frame: at baseline
Individual chronotype questionnaire
Time frame: at baseline
Food habits questionnaire
Time frame: at baseline
Total energy intake dietary questionnaire
Time frame: at baseline
Macronutrient distribution dietary questionnaire
Time frame: at baseline
Glycemic Index questionnaire
Time frame: at baseline
Barriers to Weight Loss checklist
Time frame: at baseline
Emotional eating questionnaire
Time frame: at baseline
Physical activity questionnaire
Time frame: at baseline
Mediterranean Diet Score questionnaire
Time frame: at baseline
Glucose tolerance
Time frame: from 1 year to 3 years after weight loss treatment
Daily rhythms of wrist temperature
Time frame: from 3 months to 3 years after weight loss treatment
Daily rhythms of activity
Time frame: from 3 months to 3 years after weight loss treatment
Daily rhythms of autonomus system by ambulatory electrocardiography
Time frame: from 3 months to 3 years after weight loss treatment
Glucose
Time frame: at baseline
Insulin
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 27629052Garaulet M, Vera B, Bonnet-Rubio G, Gomez-Abellan P, Lee YC, Ordovas JM. Lunch eating predicts weight-loss effectiveness in carriers of the common allele at PERILIPIN1: the ONTIME (Obesity, Nutrigenetics, Timing, Mediterranean) study. Am J Clin Nutr. 2016 Oct;104(4):1160-1166. doi: 10.3945/ajcn.116.134528. Epub 2016 Sep 14.
- Background: PubMed 27093617Gomez-Santos C, Saura CB, Lucas JA, Castell P, Madrid JA, Garaulet M. Menopause status is associated with circadian- and sleep-related alterations. Menopause. 2016 Jun;23(6):682-90. doi: 10.1097/GME.0000000000000612.
- Background: PubMed 24953771Corbalan-Tutau MD, Gomez-Abellan P, Madrid JA, Canteras M, Ordovas JM, Garaulet M. Toward a chronobiological characterization of obesity and metabolic syndrome in clinical practice. Clin Nutr. 2015 Jun;34(3):477-83. doi: 10.1016/j.clnu.2014.05.007. Epub 2014 May 28.
- Background: PubMed 24905098Lopez-Guimera G, Dashti HS, Smith CE, Sanchez-Carracedo D, Ordovas JM, Garaulet M. CLOCK 3111 T/C SNP interacts with emotional eating behavior for weight-loss in a Mediterranean population. PLoS One. 2014 Jun 6;9(6):e99152. doi: 10.1371/journal.pone.0099152. eCollection 2014.
- Background: PubMed 24548145Dashti HS, Smith CE, Lee YC, Parnell LD, Lai CQ, Arnett DK, Ordovas JM, Garaulet M. CRY1 circadian gene variant interacts with carbohydrate intake for insulin resistance in two independent populations: Mediterranean and North American. Chronobiol Int. 2014 Jun;31(5):660-7. doi: 10.3109/07420528.2014.886587. Epub 2014 Feb 18.
- Background: PubMed 24232497Bandin C, Martinez-Nicolas A, Ordovas JM, Madrid JA, Garaulet M. Circadian rhythmicity as a predictor of weight-loss effectiveness. Int J Obes (Lond). 2014 Aug;38(8):1083-8. doi: 10.1038/ijo.2013.211. Epub 2013 Nov 15.
- Background: PubMed 24173768Garaulet M, Smith CE, Gomez-Abellan P, Ordovas-Montanes M, Lee YC, Parnell LD, Arnett DK, Ordovas JM. REV-ERB-ALPHA circadian gene variant associates with obesity in two independent populations: Mediterranean and North American. Mol Nutr Food Res. 2014 Apr;58(4):821-9. doi: 10.1002/mnfr.201300361. Epub 2013 Oct 31.
- Background: PubMed 24010751Garaulet M, Gomez-Abellan P. Chronobiology and obesity. Nutr Hosp. 2013 Sep;28 Suppl 5:114-20. doi: 10.3305/nh.2013.28.sup5.6926.
- Background: PubMed 23889612Morales-Falo EM, Sanchez-Moreno C, Esteban A, Alburquerque JJ, Garaulet M. [Quality of the diet "before and during" a weight loss treatment based on Mediterranean Diet; behavioural therapy and nutritional education]. Nutr Hosp. 2013 Jul-Aug;28(4):980-7. doi: 10.3305/nh.2013.28.4.6665. Spanish.
- Background: PubMed 23357955Garaulet M, Gomez-Abellan P, Alburquerque-Bejar JJ, Lee YC, Ordovas JM, Scheer FA. Timing of food intake predicts weight loss effectiveness. Int J Obes (Lond). 2013 Apr;37(4):604-11. doi: 10.1038/ijo.2012.229. Epub 2013 Jan 29.
- Background: PubMed 23183326Bandin C, Martinez-Nicolas A, Ordovas JM, Ros Lucas JA, Castell P, Silvente T, Madrid JA, Garaulet M. Differences in circadian rhythmicity in CLOCK 3111T/C genetic variants in moderate obese women as assessed by thermometry, actimetry and body position. Int J Obes (Lond). 2013 Aug;37(8):1044-50. doi: 10.1038/ijo.2012.180. Epub 2012 Nov 20.
- Background: PubMed 23003921Milagro FI, Gomez-Abellan P, Campion J, Martinez JA, Ordovas JM, Garaulet M. CLOCK, PER2 and BMAL1 DNA methylation: association with obesity and metabolic syndrome characteristics and monounsaturated fat intake. Chronobiol Int. 2012 Nov;29(9):1180-94. doi: 10.3109/07420528.2012.719967. Epub 2012 Sep 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Garaulet, PHD principal investigator
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Universidad de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Garaulet, PHD (+34-678996368, garaulet@um.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total weight loss (time frame: weekly, during the 28 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02829619, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.