Skip to main content
Delfa

← All trials/NCT01561235

Protein

CompletedPhase NA

Protein Dose-repsonse Effect on GLP-1, PYY and Appetite in Male Subjects

The Contribution of Gastrointestinal Appetite Hormones to Protein-induced

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

-

Actual enrollment

25

Study population

Obesity / overweight

Eligibility highlights

•BMI 18.5-40•Male•Healthy volunteers

Primary endpoint

•Acute 4-h changes from baseline in the postprandial concentration of GLP-1

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01561235
Org study IDB243

Timeline

Milestones

Study first posted2012-03-22estimated
Last update posted2012-06-21estimated
Study start2008-02 (month precision)
Primary completion2008-07actual (month precision)
Study completion2008-07actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
Maximum age50 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

•Healthy,
•BMI: 18.5-40 kg/m2,
•Weight stable (within +/- 3 kg) two months prior to study inclusion,
•Non-smoking,
•Nonathletic,

Exclusion criteria

•BMI > 40 kg/m2,
•Change in smoking status,
•Daily or frequent use of medication,
•Suffering from metabolic diseases,
•Suffering from psychiatric diseases,
•Suffering from any other clinical condition, which would make the subject unfit to participate in the study,
•Blood pressure was above 150/90 mmHg,
•Hemoglobin < 8 mmol/l.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
9
Glycemic / diabetes
2
Cardiometabolic biomarkers
1

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Acute 4-h changes from baseline in the postprandial concentration of glucose

Time frame:Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes post intake.

concentration, descriptive

Secondary/protocol endpoint

Acute 4-h changes from baseline in the postprandial concentration of insulin

Time frame:Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes post intake.

concentration, descriptive

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Acute 4-h changes from baseline in the postprandial concentrations of lipids

Time frame:Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake.

concentration, descriptive

Other (unclassified)

9 endpoints
Primary/protocol endpoint/low confidence

Acute 4-h changes from baseline in the postprandial concentration of GLP-1

Time frame:Measured on 3 seperate test days in a crossover design. Each test day was seperated by >4 weeks. On each test day GLP-1 was measured prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake

concentration, descriptive

Secondary/protocol endpoint/low confidence

Acute 4-h changes from baseline in subjective appetite sensations using visual analogue scales

Time frame:Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day appetite sensations were measured prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 210, 240 minutes post intake.

descriptive

Secondary/protocol endpoint/low confidence

Acute 4-h changes from baseline in the postprandial concentration of appetite regulating hormones/peptides

Time frame:Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake.

concentration, descriptive

Secondary/protocol endpoint/low confidence

Acute 4-h changes from baseline in the body temperature

Time frame:Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day temperature was measured prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 210, 240 minutes post intake.

descriptive

Secondary/protocol endpoint/low confidence

Rate of gastric emptying (4-h change from baseline in postprandial concentration of paracetamol)

Time frame:Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Rating of the organoleptic quality of the test meals

Time frame:Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day after completion of the test meal (approximately) time 15 minutes post intake) subjects rated the test meals

descriptive

Secondary/protocol endpoint/low confidence

Rating of the organoleptic quality of the ad libitum meal

Time frame:Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day after completion of the ad libitum meal subjects rated the meal

descriptive

Secondary/protocol endpoint/low confidence

Subjective appetite sensations (visual analogue scales) after ad libitum meal

Time frame:Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day after completion of the ad libitum meal subjects rated their subjective sensation of appetite (approximately 4.5-h post intake of the test meal)

descriptive

Secondary/protocol endpoint/low confidence

ad libitum energy intake (EI)

Time frame:Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. EI was measured 240 min after intake of the test meal

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.