Clinical trial · Interventional

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

NCT02248272CI-TRIAL-00029770completedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Hyperglycemia	—	UNRESOLVED	—
Hyperinsulinism	—	UNRESOLVED	—
Impaired Glucose Tolerance	—	UNRESOLVED	—
Insulin Sensitivity	—	UNRESOLVED	—
Poor Glycemic Control	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Isocaloric diet with 3 meals	Other	—	UNRESOLVED
Isocaloric diet with 6 meals	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
Polycystic Ovary Syndrome
description
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.
interventionNames
1. Other: Isocaloric diet with 3 meals
2. Other: Isocaloric diet with 6 meals
type
EXPERIMENTAL
label
Impaired Glucose Tolerance
description
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.

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

Inclusion Criteria:

* The presence of type 2 diabetes was defined according to the current diagnostic criteria: (a) HbA1c ≥ 6.5%, (b) fasting plasma glucose ≥126 mg/dl (7.0 mmol/l). (c) 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test (OGTT), using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water, or (d) a random plasma glucose ≥ 200 mg/dl (11.1 mmol/l) in patients with classic symptoms of hyperglycemia or hyperglycemic crisis.
* PCOS was defined according to the Rotterdam criteria (Rotterdam 2004) which include the presence of two or more of the following features: chronic oligoovulation or anovulation (fewer than six menstrual periods in the previous year), androgen excess (serum total testosterone \>70 mg/dl) and polycystic ovaries.

Exclusion Criteria:

* Insulin sensitizers, i.e. metformin, contraceptives, steroids or any medications known to affect glucose, insulin or reproductive hormones for at least the last 6 months.
* Serious health problems like cardiovascular, liver or kidney diseases.
* Volunteers who were on diet, using medications affecting body mass or who had experienced a change in body weight ≥ 4.5 kg or a change in physical activity within the 6 months preceding the study onset were excluded.

References

Publications (0)

Data not yet available

No reference posted for this study.