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Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa
This study has been completed.
Sponsor:
University Hospital, Geneva
Collaborator:
Danone Research
Information provided by (Responsible Party):
Rene Rizzoli, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01823822
First received: March 29, 2013
Last updated: April 2, 2013
Last verified: March 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Anorexia Nervosa | Dietary Supplement: Oral protein supplement (Tested product) Dietary Supplement: Iso-caloric supplement (Control product) | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
Further study details as provided by Rene Rizzoli, University Hospital, Geneva:
Primary Outcome Measures:
- 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.
| Enrollment: | 62 |
| Study Start Date: | June 2008 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Detailed Description:
Study centres: 4 active centres in France and 2 active centres in Switzerland
Eligibility| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01823822
Please refer to this study by its ClinicalTrials.gov identifier: NCT01823822
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 ) |
| Study First Received: | March 29, 2013 |
| Last Updated: | April 2, 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 |
ClinicalTrials.gov processed this record on July 19, 2017