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

NCT ID: NCT01823822

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-04-30

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

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oral protein supplement (Tested product)

Group Type: EXPERIMENTAL

Oral protein supplement (Tested product)

Intervention Type: DIETARY_SUPPLEMENT

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.

Iso-caloric supplement (Control product)

Group Type: ACTIVE_COMPARATOR

Iso-caloric supplement (Control product)

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Rene Rizzoli

René Rizzoli, MD (Principal Investigator)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

René Rizzoli, MD

Role: PRINCIPAL_INVESTIGATOR

Bone Diseases Service, Department of Internal Medicine Specialties, University Hospitals and Faculty of Medicine of Geneva

Locations

Bone Diseases Service, Geneva University Hospitals

Geneva, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 26602423 (View on PubMed)

Other Identifiers

NU185

Identifier Type: OTHER

Identifier Source: secondary_id

07-182

Identifier Type: -

Identifier Source: org_study_id