Gut Hormones After Meal Ingestion in Males Versus Females

Normal Non-fluency Clinical Trial

Official title:

Effects of Varying Meal Size on Gut Hormone and Islet Hormone Secretion in Males Versus Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366781
• Other study ID #: 004
• Status: Completed
• Phase: N/A
• First received: May 31, 2011
• Last updated: September 29, 2014
• Start date: May 2011
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The study hypothesis is that the release of gut hormones is increased proportionally to caloric load in each meal. Three different meals with different meal size will therefore be served and gut hormones determined.

Description:

In healthy males and females, meals with 511, 743 and 1034 kcal will be given orally. Samples will be taken during the following 300 min and gut hormones (glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1) will be determined along with insulin and glucagon levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• Healthy status

Exclusion Criteria:

• Diabetes

• Liver disease

• kidney disease

• thyroid disease

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Normal Non-fluency

Intervention

Other:
• Meal ingestion
Meal 511 kcal, meal 743 kcal or meal 1034 kcal

Locations

Country	Name	City	State
Sweden	Department of Clinical Sciences Lund, Lund University	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Release of gut hormones		300 min	No
Secondary	Insulin secretion		300 min	No