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

April 2, 2013 updated by: Rene Rizzoli, University Hospital, Geneva
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland
        • Bone Diseases Service, Geneva University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

Danone Research

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

March 29, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (Estimate)

April 4, 2013

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 2, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-182
  • NU185 (Other Identifier: Danone Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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