Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa
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ClinicalTrials.gov Identifier: NCT01823822 |
Recruitment Status
:
Completed
First Posted
: April 4, 2013
Last Update Posted
: April 4, 2013
|
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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 |
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 |

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.
|
- 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.

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823822
Switzerland | |
Bone Diseases Service, Geneva University Hospitals | |
Geneva, Switzerland |
Principal Investigator: | René Rizzoli, MD | Bone Diseases Service, Department of Internal Medicine Specialties, University Hospitals and Faculty of Medicine of Geneva |
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 ) |
First Posted: | April 4, 2013 Key Record Dates |
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 |