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Trial record 55 of 750 for:    Area Under Curve AND meal

Glucose Tolerance, Meal Timing and MTNR1B (ONTIME-DINE)

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ClinicalTrials.gov Identifier: NCT03003936
Recruitment Status : Completed
First Posted : December 28, 2016
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
PROF. MARTA GARAULET AZA, Universidad de Murcia

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.

Condition or disease Intervention/treatment Phase
Non-Diabetic Disorder of Endocrine Pancreas Behavioral: Dinner timing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Glucose Tolerance, Meal Timing and MTNR1B in a Mediterranean Population
Study Start Date : December 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: Early Dinner Timing
Test the lack of concurrence of meal timing with endogenous melatonin concentrations
Behavioral: Dinner 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.

Experimental: Late Dinner Timing
Test the concurrence of meal timing with elevated endogenous melatonin concentrations
Behavioral: Dinner 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003936


Locations
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Spain
University of Murcia
Murcia, Spain, 30100
Sponsors and Collaborators
Universidad de Murcia
Investigators
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Study Director: Marta Garaulet, PHD Universidad de Murcia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PROF. MARTA GARAULET AZA, Full Proffesor, Universidad de Murcia
ClinicalTrials.gov Identifier: NCT03003936     History of Changes
Other Study ID Numbers: 15123/PI/10
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by PROF. MARTA GARAULET AZA, Universidad de Murcia:
Glucose tolerance
MTNR1B
nutrigenomics
Food timing
Additional relevant MeSH terms:
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Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants