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Completed

NCT Number: NCT03003936

Glucose Tolerance, Meal Timing and MTNR1B

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.

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Key information

Conditions

Non-Diabetic Disorder of Endocrine Pancreas

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Murcia

Murcia, 30100, Spain

About this study

Late-night dinner eating is associated with increased risk for type-2-diabetes. The underlying mechanism is unclear. One explanatory hypothesis is that the concurrence of elevated circulating melatonin and high glucose concentrations (characterizing late-eating) leads to impaired glucose-tolerance. However, to date, no study has tested the influence of physiological melatonin concentrations on glucose tolerance. The discovery of melatonin receptor MTNR1B as a diabetes risk gene provides evidence for a role of physiological levels of melatonin in glucose control.

The aim of the current study is to test the hypothesis that the concurrence of meal timing with elevated endogenous melatonin concentrations results in impaired glucose control and that this effect is stronger in homozygous MTNR1B risk carriers than in non-carriers. To do so we will test glucose tolerance using identical mixed meals under two dinner conditions: a) delayed dinner or Late Eating (LE): starting1 hour before usual bed time, b) advanced dinner or Early Eating (EE): starting 4 hours before habitual bed time, in a randomized, cross-over study design.

These findings could support a clinical application for the screening of this single nucleotide polymorphism (SNP) and the possibility of implementing tailored and cost-effective behavioral interventions to prevent type 2 diabetes in vulnerable populations.

These goals will be achieved through a specific approach:

  • Interventional (randomized, cross-over controlled trials) (Aim 1): To study the potential interaction between meal timing (dinner) and genetic variants MTNR1B for glucose tolerance.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index: >19 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

Treatment and study plan

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.

Primary outcomes

  1. Area Under the Curve (AUC) glucose

    Time frame: between 0-120 minutes, Visit 2 and 3

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

Secondary outcomes

  1. Fasting glucose

    Time frame: between 0-120 minutes, Visit 2 and 3

  2. Saliva Melatonin

    Time frame: between 0-120 minutes, Visit 2 and 3

Other outcomes

  1. Sleep Duration

    Time frame: total of 2 weeks between Visit 1 and 3

    Sleep duration will be computed from self-reported.

  2. Light Exposure

    Time frame: total of 2 weeks between Visit 1 and 3

    Measured using Pendant G Acceleration Data Logger.

  3. Total Energy Intake

    Time frame: total of 2 weeks between Visit 1 and 3

    Total energy intake in kcal/day will be computed from 14-day 24-hr dietary record.

  4. Dietary Composition

    Time frame: total of 2 weeks between Visit 1 and 3

    Macronutrient and micronutrient intake will be computed from 14-days of self-reported 24-hr dietary record.

  5. Dietary Intake Timing

    Time frame: total of 2 weeks between Visit 1 and 3

    Food timing will be self-reported and averaged across 14-days of 24-hr dietary record.

  6. Chronotype

    Time frame: at baseline

    Assessed using the Morningness-Eveningness Questionnaire (MEQ).

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

Glucose Tolerance, Meal Timing and MTNR1B in a Mediterranean Population

Acronym: ONTIME-DINE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 28, 2016
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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