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

NCT01823822 | Completed Phase 2

• 2 other identifiers: 07-182NU185
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosa; Protein supplements; IGF-I

Outcome Measures

Primary Outcomes (1)

• 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.

  4-week

Study Arms (2)

Oral protein supplement (Tested product)

EXPERIMENTAL

Dietary Supplement: Oral protein supplement (Tested product)

Iso-caloric supplement (Control product)

ACTIVE COMPARATOR

Dietary Supplement: Iso-caloric supplement (Control product)

Interventions

Oral protein supplement (Tested product) 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.

Oral protein supplement (Tested product)

Iso-caloric supplement (Control product) 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.

Iso-caloric supplement (Control product)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

Bone Diseases Service, Geneva University Hospitals

Geneva, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 26602423 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• René Rizzoli, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: René Rizzoli, MD (Principal Investigator)

Study Record Dates

• First Submitted: March 29, 2013
• First Posted: April 4, 2013
• Study Start: June 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 4, 2013

Record last verified: 2013-03

Locations

CH (1)