Anorexia NervosaPhase 2/3NCT01823822
Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa
A Phase 2/3 study testing Oral protein supplement (Tested product) in people with Anorexia Nervosa, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Oral protein supplement (Tested product)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2008to Apr 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Bone Diseases Service, Geneva University Hospitals
Geneva
About this study
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.
Read the detailed description
Study centres: 4 active centres in France and 2 active centres in Switzerland
- Conditions
- Anorexia Nervosa
- Being tested
- Oral protein supplement (Tested product), Iso-caloric supplement (Control product)
- Keywords
- Anorexia nervosa, Protein supplements, IGF-I
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral protein supplement (Tested product) | Experimental | Not described Receives: Dietary Supplement: Oral protein supplement (Tested product) |
| Iso-caloric supplement (Control product) | Active comparator | Not described Receives: Dietary Supplement: Iso-caloric supplement (Control product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startJun 2008
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Responsible party
- Principal investigator, Rene Rizzoli, University Hospital, Geneva
- Investigators
- René Rizzoli, MD, Principal investigator, Bone Diseases Service, Department of Internal Medicine Specialties, University Hospitals and Faculty of Medicine of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823822
- Sponsor's protocol ID
- 07-182
- Other IDs
- NU185
- Status last verified
- Mar 2013
- First submitted
- 29 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26602423
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Protein Supplements on Serum Insulin-like Growth Factor-I Levels in Women With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT01823822
- Acronym / sponsor ID
- 07-182
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, Protein supplements, IGF-I
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Study start
- Jun 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Oral protein supplement (Tested product) |
| 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. | Dietary supplement | Iso-caloric supplement (Control product) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- Derived from this study: PubMed 26602423Trombetti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René Rizzoli, MD principal investigator
Bone Diseases Service, Department of Internal Medicine Specialties, University Hospitals and Faculty of Medicine of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oral protein supplement (Tested product) in people with Anorexia Nervosa, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum insulin like growth factor-1 (IGF-I) level (time frame: 4-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01823822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.