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

Study Overview
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Brief Summary
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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
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Study centres: 4 active centres in France and 2 active centres in Switzerland

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

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Dietary Supplement: Oral protein supplement (Tested product)
* Dietary Supplement: Iso-caloric supplement (Control product)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral protein supplement (Tested product)<br> | Dietary Supplement: Oral protein supplement (Tested product)<br>* 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.<br>|
| Active Comparator: Iso-caloric supplement (Control product)<br> | Dietary Supplement: Iso-caloric supplement (Control product)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorexia nervosa, Protein supplements, IGF-I