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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01823822
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : April 4, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : June 2008
Primary Completion Date : March 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Serum insulin like growth factor-1 (IGF-I) level [ Time Frame: 4-week ]
    The main study product effect criterion is the IGF-I level over the 4-week consumption period.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( Other Identifier: Danone Research )
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: March 2013

Keywords provided by Rene Rizzoli, University Hospital, Geneva:
Anorexia nervosa
Protein supplements
IGF-I

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action