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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Oral protein supplement (Tested product)
Iso-caloric supplement (Control product)
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia nervosa, Protein supplements, IGF-I

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Bone Diseases Service, Geneva University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral protein supplement (Tested product)

Iso-caloric supplement (Control product)

Arm Description

Outcomes

Primary Outcome Measures

Serum insulin like growth factor-1 (IGF-I) level
The main study product effect criterion is the IGF-I level over the 4-week consumption period.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2013
Last Updated
April 2, 2013
Sponsor
University Hospital, Geneva
Collaborators
Danone Research
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1. Study Identification

Unique Protocol Identification Number
NCT01823822
Brief Title
Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa
Official Title
Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
Collaborators
Danone Research

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
Study centres: 4 active centres in France and 2 active centres in Switzerland

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Anorexia nervosa, Protein supplements, IGF-I

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral protein supplement (Tested product)
Arm Type
Experimental
Arm Title
Iso-caloric supplement (Control product)
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral protein supplement (Tested product)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Iso-caloric supplement (Control product)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum insulin like growth factor-1 (IGF-I) level
Description
The main study product effect criterion is the IGF-I level over the 4-week consumption period.
Time Frame
4-week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
René Rizzoli, MD
Organizational Affiliation
Bone Diseases Service, Department of Internal Medicine Specialties, University Hospitals and Faculty of Medicine of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bone Diseases Service, Geneva University Hospitals
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
26602423
Citation
Trombetti A, Carrier E, Perroud A, Lang F, Herrmann FR, Rizzoli R. Influence of a fermented protein-fortified dairy product on serum insulin-like growth factor-I in women with anorexia nervosa: A randomized controlled trial. Clin Nutr. 2016 Oct;35(5):1032-8. doi: 10.1016/j.clnu.2015.10.014. Epub 2015 Nov 5.
Results Reference
derived

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

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