Anorexia Nervosa
Conditions
Keywords
Anorexia nervosa, Protein supplements, IGF-I
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
Interventions
DIETARY_SUPPLEMENTOral 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.
DIETARY_SUPPLEMENTIso-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.
Sponsors
Danone Global Research & Innovation Center
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Switzerland
Outcome results
None listed