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Glucose Tolerance, Meal Timing and MTNR1B

Glucose Tolerance, Meal Timing and MTNR1B in a Mediterranean Population

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03003936
Acronym
ONTIME-DINE
Enrollment
280
Registered
2016-12-28
Start date
2014-12-31
Completion date
2017-06-30
Last updated
2017-10-27

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

Conditions

Non-Diabetic Disorder of Endocrine Pancreas

Keywords

Glucose tolerance, MTNR1B, nutrigenomics, Food timing

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.

Detailed description

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.

Interventions

BEHAVIORALDinner timing

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.

Sponsors

Universidad de Murcia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Area Under the Curve (AUC) glucosebetween 0-120 minutes, Visit 2 and 3Investigators will measure glucose levels for 120 minutes at day time and night time visits, and compare the results by genotype at selected loci.

Secondary

MeasureTime frame
Fasting glucosebetween 0-120 minutes, Visit 2 and 3
Saliva Melatoninbetween 0-120 minutes, Visit 2 and 3

Other

MeasureTime frameDescription
Dietary Compositiontotal of 2 weeks between Visit 1 and 3Macronutrient and micronutrient intake will be computed from 14-days of self-reported 24-hr dietary record.
Sleep Durationtotal of 2 weeks between Visit 1 and 3Sleep duration will be computed from self-reported.
Chronotypeat baselineAssessed using the Morningness-Eveningness Questionnaire (MEQ).
Dietary Intake Timingtotal of 2 weeks between Visit 1 and 3Food timing will be self-reported and averaged across 14-days of 24-hr dietary record.
Light Exposuretotal of 2 weeks between Visit 1 and 3Measured using Pendant G Acceleration Data Logger.
Total Energy Intaketotal of 2 weeks between Visit 1 and 3Total energy intake in kcal/day will be computed from 14-day 24-hr dietary record.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026