Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01823822|
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : April 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa||Dietary Supplement: Oral protein supplement (Tested product) Dietary Supplement: Iso-caloric supplement (Control product)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||April 2009|
|Experimental: Oral protein supplement (Tested product)||
Dietary Supplement: Oral protein supplement (Tested product)
Test product: oral protein supplement, sweetened flavoured dairy product, type fresh cheese rich in milk protein (15 g/150 grams). Dosage is 2 pots daily, at least 5 days/week for 4 consecutive weeks.
|Active Comparator: Iso-caloric supplement (Control product)||
Dietary Supplement: Iso-caloric supplement (Control product)
Control product: sweetened flavoured fresh cheese, with low milk protein content (3 g/150 grams). Dosage is 2 pots daily, at least 5 days/week for 4 consecutive weeks.
- Serum insulin like growth factor-1 (IGF-I) level [ Time Frame: 4-week ]The main study product effect criterion is the IGF-I level over the 4-week consumption period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823822
|Bone Diseases Service, Geneva University Hospitals|
|Principal Investigator:||René Rizzoli, MD||Bone Diseases Service, Department of Internal Medicine Specialties, University Hospitals and Faculty of Medicine of Geneva|