Glucose Tolerance, Meal Timing and MTNR1B

NCT03003936 | Completed DMC

• 1 other identifier: 15123/PI/10
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigation is to assess in a community-based cohort of late-night eaters the effect of coincident food intake and endogenous melatonin on glycemic control, and the putative interaction effect of melatonin receptor 1B (MTNR1B) genetic variation on this relationship. With the results from this study, the investigators expect to advance in the understanding of the role of endogenous melatonin on glucose metabolism in late night eaters and carriers of the MTNR1B risk allele, with potential implications on the guidelines to mitigate risk of type 2 diabetes in late night eaters and carriers of the MTNR1B risk allele.

Conditions

Non-Diabetic Disorder of Endocrine Pancreas

Keywords

Glucose tolerance; MTNR1B; nutrigenomics; Food timing

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) glucose

  Investigators will measure glucose levels for 120 minutes at day time and night time visits, and compare the results by genotype at selected loci.

  between 0-120 minutes, Visit 2 and 3

Secondary Outcomes (2)

• Fasting glucose

  between 0-120 minutes, Visit 2 and 3

• Saliva Melatonin

  between 0-120 minutes, Visit 2 and 3

Other Outcomes (6)

• Sleep Duration

  total of 2 weeks between Visit 1 and 3

• Light Exposure

  total of 2 weeks between Visit 1 and 3

• Total Energy Intake

  total of 2 weeks between Visit 1 and 3

Study Arms (2)

Early Dinner Timing

EXPERIMENTAL

Test the lack of concurrence of meal timing with endogenous melatonin concentrations

Behavioral: Dinner timing

Late Dinner Timing

EXPERIMENTAL

Test the concurrence of meal timing with elevated endogenous melatonin concentrations

Behavioral: Dinner timing

Interventions

Dinner timing BEHAVIORAL

Glucose tolerance after a late diner (1 hour before habitual bedtime) differs from early dinner (4 hours before habitual bedtime) due to the concurrence of meal timing with different levels of endogenous melatonin. This effect can be different among risk allele carriers (G) or non-rick allele carriers (C) of the MTNR1B.

Early Dinner Timing; Late Dinner Timing

Eligibility Criteria

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

You may qualify if:

• Body Mass Index: \>19 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, 30100, Spain

Location

Related Publications (1)

• Lopez-Minguez J, Saxena R, Bandin C, Scheer FA, Garaulet M. Late dinner impairs glucose tolerance in MTNR1B risk allele carriers: A randomized, cross-over study. Clin Nutr. 2018 Aug;37(4):1133-1140. doi: 10.1016/j.clnu.2017.04.003. Epub 2017 Apr 10.

  PMID: 28455106 DERIVED

Study Officials

• Marta Garaulet, PHD

  Universidad de Murcia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Proffesor

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 28, 2016
• Study Start: December 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)