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Gut Hormones After Meal Ingestion in Males Versus Females

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bo Ahren, Lund University
ClinicalTrials.gov Identifier:
NCT01366781
First received: May 31, 2011
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Normal Non-fluency
 Other: Meal ingestion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Effects of Varying Meal Size on Gut Hormone and Islet Hormone Secretion in Males Versus Females

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lund University:

Primary Outcome Measures:
  • Release of gut hormones [ Time Frame: 300 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin secretion [ Time Frame: 300 min ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2011
Estimated Study Completion Date: March 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy males
Meal ingestion in healthy males
 Other: Meal ingestion
Meal 511 kcal, meal 743 kcal or meal 1034 kcal
Other Name: Meal ingestion
Experimental: Healthy females
Meal ingestion in healthy females
 Other: Meal ingestion
Meal 511 kcal, meal 743 kcal or meal 1034 kcal
Other Name: Meal ingestion

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy status

Exclusion Criteria:

  • Diabetes
  • Liver disease
  • kidney disease
  • thyroid disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366781

Locations
Sweden
Department of Clinical Sciences Lund, Lund University
Lund, Sweden, 221 84
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Bo Ahrén, PhD Lund University
  More Information

No publications provided

Responsible Party: Bo Ahren, Professor, Lund University
ClinicalTrials.gov Identifier: NCT01366781     History of Changes
Other Study ID Numbers: 004
Study First Received: May 31, 2011
Last Updated: October 9, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Lund University:
Gut hormones
Insulin secretion

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013