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OpenTrials
Completed

NCT Number: NCT01456754

Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men

The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning in impaired glucose tolerant (IGT) men.

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Key information

Conditions

Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Maastricht

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI: 20-35 kg/m2
  • Gender: Male
  • Age: subjects has to be older than 18 and younger than 70 years old
  • Impaired Glucose Tolerant (IGT) = plasma glucose, two hours after consuming 75g glucose, appears to be superior to 7.8mmol/l (normal level) but remains inferior to 11.1mmol/l (diabetes level) and fasting plasma glucose is less than 7.0mmol/l.
  • Caucasian

Exclusion criteria

  • Lactose intolerant
  • Diabetes Mellitus
  • Cardiovascular diseases
  • Stomach and intestinal diseases
  • Normal glucose levels after 2 hours
  • Anticoagulants
  • Medication that has a effect on energy and glucose homeostasis and absorption of foods
  • Conditions or situations when subjects can't lose 500 ml blood

Treatment and study plan

low feeding frequency (3x)

Dietary Supplement

3 meals a day

High feeding frequency (14x)

Dietary Supplement

14 meals a day

Primary outcomes

  1. Glucose metabolism

    Time frame: 24 hour profile

  2. Insulin metabolism

    Time frame: 24 hour profile

Secondary outcomes

  1. Change in substrate partitioning (fat, carbohydrate and protein oxidation) between the two intervention diets

    Time frame: 24 hour profiles

  2. Metabolic markers (FFA and TG metabolism)

    Time frame: 24 hour profile

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Nederlandse Zuivel Organisatie

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 21, 2011
Registry last updated
Dec 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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