- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01366781
Gut Hormones After Meal Ingestion in Males Versus Females
September 29, 2014 updated by: Bo Ahren, Lund University
Effects of Varying Meal Size on Gut Hormone and Islet Hormone Secretion in Males Versus Females
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lund, Sweden, 221 84
- Department of Clinical Sciences Lund, Lund University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy status
Exclusion Criteria:
- Diabetes
- Liver disease
- kidney disease
- thyroid disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NON_RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Healthy males
Meal ingestion in healthy males
|
Meal 511 kcal, meal 743 kcal or meal 1034 kcal
|
EXPERIMENTAL: Healthy females
Meal ingestion in healthy females
|
Meal 511 kcal, meal 743 kcal or meal 1034 kcal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Release of gut hormones
Time Frame: 300 min
|
300 min
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insulin secretion
Time Frame: 300 min
|
300 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (ACTUAL)
February 1, 2014
Study Completion (ACTUAL)
June 1, 2014
Study Registration Dates
First Submitted
May 31, 2011
First Submitted That Met QC Criteria
June 2, 2011
First Posted (ESTIMATE)
June 6, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
September 30, 2014
Last Update Submitted That Met QC Criteria
September 29, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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