Meal Timing, Genetics and Weight Loss

NCT02829619 | Recruiting DMC

• 2 other identifiers: R01DK105072-1R01DK105072
• Study Type: observational
• Target: 5,788
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Nutrigenetics; Food Timing; Weight loss

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  once at least one year after ending the treatment

Secondary Outcomes (18)

• Food timing

  at baseline

• Sleep timing

  at baseline

• Siesta timing questionnaire

  at baseline

• Individual chronotype questionnaire

  at baseline

• Food habits questionnaire

  at baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

University of Murcia

Murcia, Murcia, 30100, Spain

RECRUITING

Related Publications (34)

• 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.

  PMID: 27629052 BACKGROUND

• Gomez-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.

  PMID: 27093617 BACKGROUND

• Corbalan-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.

  PMID: 24953771 BACKGROUND

• Lopez-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.

  PMID: 24905098 BACKGROUND

• Dashti 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.

  PMID: 24548145 BACKGROUND

• Bandin 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.

  PMID: 24232497 BACKGROUND

• Garaulet 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.

  PMID: 24173768 BACKGROUND

• Garaulet M, Gomez-Abellan P. Chronobiology and obesity. Nutr Hosp. 2013 Sep;28 Suppl 5:114-20. doi: 10.3305/nh.2013.28.sup5.6926.

  PMID: 24010751 BACKGROUND

• Morales-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.

  PMID: 23889612 BACKGROUND

• Garaulet 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.

  PMID: 23357955 BACKGROUND

• Bandin 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.

  PMID: 23183326 BACKGROUND

• Milagro 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.

  PMID: 23003921 BACKGROUND

• Garaulet 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.

  PMID: 22732995 BACKGROUND

• Corbalan-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.

  PMID: 22705307 BACKGROUND

• Corbalan-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.

  PMID: 22450522 BACKGROUND

• Garaulet M, Esteban Tardido A, Lee YC, Smith CE, Parnell LD, Ordovas JM. SIRT1 and CLOCK 3111T> C combined genotype is associated with evening preference and weight loss resistance in a behavioral therapy treatment for obesity. Int J Obes (Lond). 2012 Nov;36(11):1436-41. doi: 10.1038/ijo.2011.270. Epub 2012 Feb 7.

  PMID: 22310473 BACKGROUND

• Garaulet M, Smith CE, Hernandez-Gonzalez T, Lee YC, Ordovas JM. PPARgamma Pro12Ala interacts with fat intake for obesity and weight loss in a behavioural treatment based on the Mediterranean diet. Mol Nutr Food Res. 2011 Dec;55(12):1771-9. doi: 10.1002/mnfr.201100437. Epub 2011 Nov 21.

  PMID: 22102511 BACKGROUND

• Corbalan-Tutau MD, Madrid JA, Ordovas JM, Smith CE, Nicolas F, Garaulet M. Differences in daily rhythms of wrist temperature between obese and normal-weight women: associations with metabolic syndrome features. Chronobiol Int. 2011 May;28(5):425-33. doi: 10.3109/07420528.2011.574766.

  PMID: 21721858 BACKGROUND

• Smith CE, Ordovas JM, Sanchez-Moreno C, Lee YC, Garaulet M. Apolipoprotein A-II polymorphism: relationships to behavioural and hormonal mediators of obesity. Int J Obes (Lond). 2012 Jan;36(1):130-6. doi: 10.1038/ijo.2011.24. Epub 2011 Mar 8.

  PMID: 21386805 BACKGROUND

• Sanchez-Moreno C, Ordovas JM, Smith CE, Baraza JC, Lee YC, Garaulet M. APOA5 gene variation interacts with dietary fat intake to modulate obesity and circulating triglycerides in a Mediterranean population. J Nutr. 2011 Mar;141(3):380-5. doi: 10.3945/jn.110.130344. Epub 2011 Jan 5.

  PMID: 21209257 BACKGROUND

• Garaulet M, Corbalan-Tutau MD, Madrid JA, Baraza JC, Parnell LD, Lee YC, Ordovas JM. PERIOD2 variants are associated with abdominal obesity, psycho-behavioral factors, and attrition in the dietary treatment of obesity. J Am Diet Assoc. 2010 Jun;110(6):917-21. doi: 10.1016/j.jada.2010.03.017.

  PMID: 20497782 BACKGROUND

• Garaulet M, Corbalan MD, Madrid JA, Morales E, Baraza JC, Lee YC, Ordovas JM. CLOCK gene is implicated in weight reduction in obese patients participating in a dietary programme based on the Mediterranean diet. Int J Obes (Lond). 2010 Mar;34(3):516-23. doi: 10.1038/ijo.2009.255. Epub 2010 Jan 12.

  PMID: 20065968 BACKGROUND

• Garaulet M, Lee YC, Shen J, Parnell LD, Arnett DK, Tsai MY, Lai CQ, Ordovas JM. CLOCK genetic variation and metabolic syndrome risk: modulation by monounsaturated fatty acids. Am J Clin Nutr. 2009 Dec;90(6):1466-75. doi: 10.3945/ajcn.2009.27536. Epub 2009 Oct 21.

  PMID: 19846548 BACKGROUND

• Gomez-Abellan P, Hernandez-Morante JJ, Lujan JA, Madrid JA, Garaulet M. Clock genes are implicated in the human metabolic syndrome. Int J Obes (Lond). 2008 Jan;32(1):121-8. doi: 10.1038/sj.ijo.0803689. Epub 2007 Jul 24.

  PMID: 17653067 BACKGROUND

• Lo MT, Bandin C, Yang HW, Scheer FAJL, Hu K, Garaulet M. CLOCK 3111T/C genetic variant influences the daily rhythm of autonomic nervous function: relevance to body weight control. Int J Obes (Lond). 2018 Feb;42(2):190-197. doi: 10.1038/ijo.2017.168. Epub 2017 Jul 24.

  PMID: 28736443 BACKGROUND

• Bonnet G, Gomez-Abellan P, Vera B, Sanchez-Romera JF, Hernandez-Martinez AM, Sookoian S, Pirola CJ, Garaulet M. Serotonin-transporter promoter polymorphism modulates the ability to control food intake: Effect on total weight loss. Mol Nutr Food Res. 2017 Nov;61(11). doi: 10.1002/mnfr.201700494. Epub 2017 Sep 1.

  PMID: 28766852 BACKGROUND

• Vera B, Dashti HS, Gomez-Abellan P, Hernandez-Martinez AM, Esteban A, Scheer FAJL, Saxena R, Garaulet M. Modifiable lifestyle behaviors, but not a genetic risk score, associate with metabolic syndrome in evening chronotypes. Sci Rep. 2018 Jan 17;8(1):945. doi: 10.1038/s41598-017-18268-z.

  PMID: 29343740 BACKGROUND

• Dashti HS, Gomez-Abellan P, Qian J, Esteban A, Morales E, Scheer FAJL, Garaulet M. Late eating is associated with cardiometabolic risk traits, obesogenic behaviors, and impaired weight loss. Am J Clin Nutr. 2021 Jan 4;113(1):154-161. doi: 10.1093/ajcn/nqaa264.

  PMID: 33022698 BACKGROUND

• Garaulet M, Vizmanos B, Muela T, Betancourt-Nunez A, Bonmati-Carrion MA, Vetter C, Dashti HS, Saxena R, Scheer FAJL. Evening types as determined by subjective and objective measures are more emotional eaters. Obesity (Silver Spring). 2023 May;31(5):1192-1203. doi: 10.1002/oby.23749.

  PMID: 37140408 BACKGROUND

• Vizmanos B, Cascales AI, Rodriguez-Martin M, Salmeron D, Morales E, Aragon-Alonso A, Scheer FAJL, Garaulet M. Lifestyle mediators of associations among siestas, obesity, and metabolic health. Obesity (Silver Spring). 2023 May;31(5):1227-1239. doi: 10.1002/oby.23765.

  PMID: 37140401 BACKGROUND

• De la Pena-Armada R, Longo-Silva G, Rodriguez-Martin M, Yang HW, Garaulet M. Key Determinants of Weight Loss Trajectory Across Different Periods of a Behavioral Weight Loss Intervention. Obesity (Silver Spring). 2026 Feb;34(2):357-371. doi: 10.1002/oby.70113. Epub 2026 Jan 20.

  PMID: 41559528 DERIVED

• Rodriguez-Martin M, Szczerbinski L, Garaulet M, Dashti HS. The Effect of Habitual Sleep Duration on Weight Loss during a Behavioral Weight Loss Intervention in a Mediterranean Population. J Nutr. 2025 Nov;155(11):4060-4064. doi: 10.1016/j.tjnut.2025.09.010. Epub 2025 Sep 19.

  PMID: 40976481 DERIVED

• Yang HW, De la Pena-Armada R, Sun H, Peng YQ, Lo MT, Scheer FAJL, Hu K, Garaulet M. Uncovering key factors in weight loss effectiveness through machine learning. Int J Obes (Lond). 2025 Jun;49(6):1189-1199. doi: 10.1038/s41366-025-01766-w. Epub 2025 May 6.

  PMID: 40328924 DERIVED

• Dashti HS, Scheer FAJL, Saxena R, Garaulet M. Impact of polygenic score for BMI on weight loss effectiveness and genome-wide association analysis. Int J Obes (Lond). 2024 May;48(5):694-701. doi: 10.1038/s41366-024-01470-1. Epub 2024 Jan 24.

  PMID: 38267484 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, saliva

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Marta Garaulet, PHD

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Garaulet, PHD

CONTACT

+34-678996368; garaulet@um.es

Purificacion Gomez-Abellan, PHD

CONTACT

+34-968221990; puriki4@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: July 12, 2016
• Study Start: January 1, 2008
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2032
• Last Updated: May 6, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)