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

Purpose

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.

Condition	Intervention	Phase
Anorexia Nervosa	Dietary Supplement: Oral protein supplement (Tested product) Dietary Supplement: Iso-caloric supplement (Control product)	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Dietary Supplements

Drug Information available for: Insulin-like growth factor I Mecasermin rinfabate

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

Serum insulin like growth factor-1 (IGF-I) level [ Time Frame: 4-week ] [ Designated as safety issue: No ]
The main study product effect criterion is the IGF-I level over the 4-week consumption period.


Enrollment:	62
Study Start Date:	June 2008
Study Completion Date:	April 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Oral protein supplement (Tested product)	Dietary Supplement: Oral 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.
Active Comparator: Iso-caloric supplement (Control product)	Dietary Supplement: Iso-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.

Detailed Description:

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

Eligibility


Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823822

Locations


Switzerland
Bone Diseases Service, Geneva University Hospitals
Geneva, Switzerland

Sponsors and Collaborators

University Hospital, Geneva

Danone Research

Investigators


Principal Investigator:	René Rizzoli, MD	Bone Diseases Service, Department of Internal Medicine Specialties, University Hospitals and Faculty of Medicine of Geneva

More Information

No publications provided


Responsible Party:	Rene Rizzoli, René Rizzoli, MD (Principal Investigator), University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT01823822 History of Changes
Other Study ID Numbers:	07-182, NU185
Study First Received:	March 29, 2013
Last Updated:	April 2, 2013
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:


Anorexia nervosa Protein supplements IGF-I

Additional relevant MeSH terms:


Anorexia Anorexia Nervosa Eating Disorders	Mental Disorders Signs and Symptoms Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on February 27, 2015