Clinical trial NCT01823822: Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa
Official title: Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Anorexia Nervosa
Keywords: Anorexia nervosa
Protein supplements
IGF-I
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Danone Global Research & Innovation Center
First posted: 2013-04-04
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Serum insulin like growth factor-1 (IGF-I) level
timeFrame: 4-week
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Bone Diseases Service, Geneva University Hospitals
Study officials:
affiliation: Bone Diseases Service, Department of Internal Medicine Specialties, University Hospitals and Faculty of Medicine of Geneva
name: René Rizzoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trombetti A, Carrier E, Perroud A, Lang F, Herrmann FR, Rizzoli R. Influence of a fermented protein-fortified dairy product on serum insulin-like growth factor-I in women with anorexia nervosa: A randomized controlled trial. Clin Nutr. 2016 Oct;35(5):1032-8. doi: 10.1016/j.clnu.2015.10.014. Epub 2015 Nov 5.