Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823822
• Other study ID #: 07-182
• Secondary ID: NU185
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 29, 2013
• Last updated: April 2, 2013
• Start date: June 2008
• Est. completion date: April 2009

Study information

• Verified date: March 2013
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

This multicentre, randomised, double-blind, 2-parallel group, controlled trial aims to investigate whether oral milk protein supplements led to increase in serum Insulin-like Growth Factor-I levels (IGF-I) as compared with a control group fed with an iso-caloric supplement, in women with anorexia nervosa. Subjects receive either 150g/day of tested product or control product for 4-week, followed by a 4-week follow-up.

Description:

Study centres: 4 active centres in France and 2 active centres in Switzerland

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women aged between 18 to 40 years (bounds included).

• Women with a serum IGF-I level below the 25th percentile of the reference value according to the age (bounds included).

• Women who had given written inform consent.

• Women with DSM-IV-confirmed anorexia nervosa lasting for at least 6 months. Women with concomitant binge eating and purging type are also included.

• Women admitted in-hospital for weight and nutritional rehabilitation. It is anticipated that the patient will stay in-hospital during the full duration of the 4-week supplementation phase, and at least 5 weeks within the study.

• Women being already regular consumers of dairy products.

• For women with childbearing potential, use of a contraceptive method.

• Discontinuation of any mineral and vitamin supplements containing calcium and vitamin D, 1 week before starting the product consumption and during the study.

Exclusion Criteria:

• Women with primary amenorrhea;

• Women with lactose intolerance;

• Women with any other metabolic disease that could affect bone metabolism:

osteogenesis imperfecta, Paget's disease of bone, hyperthyroidism, primary hyperparathyroidism;

• Women with current or past neoplasm;

• Women with any other severe comorbidity;

• Pregnant or breast feeding women;

• Women with epilepsy;

• Women with any current or past use of the following treatments: bisphosphonates, calcitonin, steroids;

• Patients enrolled in another clinical study within the last 4 weeks;

• Patients having already received oral nutritional supplements or who need to receive other oral or intravenous (IV) supplements during the follow-up;

• Patients having received oral or IV nutritional supplements within two weeks before the inclusion;

• Patients having willed to participate in another clinical study during the present study phase and 4 weeks after the end of their participation in the present study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Bone Diseases Service, Geneva University Hospitals	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Danone Research

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum insulin like growth factor-1 (IGF-I) level	The main study product effect criterion is the IGF-I level over the 4-week consumption period.	4-week	No