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40 women with PCOS followed one of two isocaloric weight maintenance diets (isocaloric diet with 3 meals or isocaloric diet with 6 meals), tailored to individual energy needs, with the same macronutrient composition (40% carbohydrates, 25% protein, 35% fat). The energy and carbohydrate contribution for the 3 meals' diet was 20% at breakfast, 50% at lunch, 30% at dinner, whereas for the 6 meals' diet was 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 20% at dinner, 10% at before bedtime snack. Each intervention lasted 12 weeks and there was no wash out period.

35 individuals with Impaired Glucose Tolerance (IGT) followed one of two isocaloric weight maintenance diets (isocaloric diet with 3 meals or isocaloric diet with 6 meals), tailored to individual energy needs, with the same macronutrient composition (45% carbohydrates, 20% protein, 35% fat). The energy and carbohydrate contribution for the 3 meals' diet was 20% at breakfast, 50% at lunch, 30% at dinner, whereas for the 6 meals' diet was 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 20% at dinner, 10% at before bedtime snack. Each intervention lasted 12 weeks and there was no wash out period.

12 individuals diagnosed with type 2 diabetes followed one of two isocaloric weight maintenance diets (isocaloric diet with 3 meals or isocaloric diet with 6 meals), tailored to individual energy needs, with the same macronutrient composition (45% carbohydrates, 20% protein, 35% fat). The energy and carbohydrate contribution for the 3 meals' diet was 20% at breakfast, 50% at lunch, 30% at dinner, whereas for the 6 meals' diet was 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 20% at dinner, 10% at before bedtime snack. Each intervention lasted 12 weeks and there was no wash out period.

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.

Isocaloric diet with 3 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.

Isocaloric diet with 6 meals

Aimilia Papakonstantinou, PhD

Meropi Kontogianni, PhD

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.

The effect of meal frequency on diabetes risk markers (e.g. glucose and insulin metabolism) has been studied in several studies so far, both in healthy individuals and in individuals being at risk for diabetes mellitus, with or without concurrent weight loss. In addition, few studies have investigated the effect of different meal frequency on glycemic control in patients with diabetes mellitus under conditions of weight maintenance. However, the results regarding the ideal number of meals remain controversial.

To our best knowledge, there is no study available that has investigated the effect of meal frequency on glucose and insulin metabolism in lean and obese women with PCOS, in lean and obese individuals with hyperinsulinemia and impaired glucose tolerance, and in obese individuals with type 2 diabetes, independently of weight loss.

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

The Effects of Meal Frequency on Glucose, Insulin, and Insulin Sensitivity in Women With Polycystic Ovary Syndrome (PCOS), People at High Risk for Developing Type 2 Diabetes and People With Type 2 Diabetes

Clinically useful change in serum glucose, defined as the restoration of glucose within normal limits during the 2-hour oral glucose tolerance test.

Clinically useful change in serum insulin, defined as the restoration of insulin within normal limits during the 2-hour oral glucose tolerance test. Improved insulin sensitivity.

Normal serum levels of cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides.

Agricultural University of Athens

National and Kapodistrian University of Athens

Meropi Kontogianni

Assistant Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes	NCT02248272	Impaired Glucos... Hyperinsulinism Poor Glycemic C... Hyperglycemia Insulin Sensiti...	Isocaloric diet... Isocaloric diet...	-	Harokopio University
Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes	NCT02248272	Impaired Glucos... Hyperinsulinism Poor Glycemic C... Hyperglycemia Insulin Sensiti...	Isocaloric diet... Isocaloric diet...	-	Harokopio University
Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes	NCT02248272	Impaired Glucos... Hyperinsulinism Poor Glycemic C... Hyperglycemia Insulin Sensiti...	Isocaloric diet... Isocaloric diet...	-	Harokopio University
Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes	NCT02248272	Impaired Glucos... Hyperinsulinism Poor Glycemic C... Hyperglycemia Insulin Sensiti...	Isocaloric diet... Isocaloric diet...	-	Harokopio University

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