Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes

NCT02248272 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2017-10-04

No results posted yet for this study

Summary

This study investigated any potential associations between two isocaloric diets with different meal frequency (3 meals versus 6 meals) and glycemic control in people at high diabetes risk (lean and overweight/obese women with PCOS, individuals with hyperinsulinemia, individuals with impaired glucose tolerance) and diagnosed with diabetes.

Conditions

  • Impaired Glucose Tolerance
  • Hyperinsulinism
  • Poor Glycemic Control
  • Hyperglycemia
  • Insulin Sensitivity

Interventions

OTHER

Isocaloric diet with 3 meals

Isocaloric diet with 3 meals in order to maintain volunteers' weight, tailored to individual energy needs, with the same macronutrient composition. The volunteers were free to choose the foods they used to consume before. However, in order to assist them to adapt to the different meal frequency, individualized instructions were given to all volunteers before their entry to the study. An example of a 7-day diet menu was prescribed for both diet programs and analytical food exchange lists of different food groups were also provided.

OTHER

Isocaloric diet with 6 meals

Isocaloric diet with 6 meals in order to maintain volunteers' weight, tailored to individual energy needs, with the same macronutrient composition. The volunteers were free to choose the foods they used to consume before. However, in order to assist them to adapt to the different meal frequency, individualized instructions were given to all volunteers before their entry to the study. An example of a 7-day diet menu was prescribed for both diet programs and analytical food exchange lists of different food groups were also provided.

Sponsors & Collaborators

  • Agricultural University of Athens

    collaborator OTHER
  • National and Kapodistrian University of Athens

    collaborator OTHER
  • Meropi Kontogianni

    lead OTHER

Principal Investigators

  • Aimilia Papakonstantinou, PhD · Agricultural University of Athens

  • Meropi Kontogianni, PhD · Harokopio University of Athens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-09-30
Completion
2013-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02248272 on ClinicalTrials.gov