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

Study Description

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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

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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
Actual Primary Completion Date :	March 2009
Actual Study Completion Date :	April 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
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