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

University Hospitals (UH)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Anorexia Nervosa

Treatments

Dietary Supplement: Iso-caloric supplement (Control product)

Dietary Supplement: Oral protein supplement (Tested product)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01823822

07-182

NU185 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment

62 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.