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

Glucose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456754
• Other study ID #: MEC 10-3-057
• Status: Completed
• Phase: N/A
• First received: September 26, 2011
• Last updated: December 14, 2011
• Start date: December 2010
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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:

1. Lactose intolerant

2. Diabetes Mellitus

3. Cardiovascular diseases

4. Stomach and intestinal diseases

5. Normal glucose levels after 2 hours

6. Anticoagulants

7. Medication that has a effect on energy and glucose homeostasis and absorption of foods

8. Conditions or situations when subjects can't lose 500 ml blood

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance

Intervention

Dietary Supplement:
• low feeding frequency (3x)
3 meals a day
• High feeding frequency (14x)
14 meals a day

Locations

Country	Name	City	State
Netherlands	University of Maastricht	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Nederlandse Zuivel Organisatie

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose metabolism		24 hour profile	No
Primary	Insulin metabolism		24 hour profile	No
Secondary	Change in substrate partitioning (fat, carbohydrate and protein oxidation) between the two intervention diets		24 hour profiles	No
Secondary	Metabolic markers (FFA and TG metabolism)		24 hour profile	No