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

Phase 2

Completed

• Conditions: Anorexia Nervosa
• Interventions: Dietary Supplement: Oral protein supplement (Tested product); Dietary Supplement: Iso-caloric supplement (Control product)

• Registration Number: NCT01823822
• Lead Sponsor: University Hospital, Geneva

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Status Verified: 2013-03
• Study First Submitted: 2013-03-29
• Study First Submitted QC: 2013-04-02
• Last Update Submitted: 2013-04-02
• Study First Posted: 2013-04-04
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral protein supplement (Tested product)	Oral protein supplement (Tested product)	-
Iso-caloric supplement (Control product)	Iso-caloric supplement (Control product)	-

Primary Outcome Measures

Name	Time	Method
Serum insulin like growth factor-1 (IGF-I) level	4-week	The main study product effect criterion is the IGF-I level over the 4-week consumption period.

Trial Locations

Locations (1)

Bone Diseases Service, Geneva University Hospitals; 🇨🇭 Geneva, Switzerland