SarcopeniaIRISNCT03120026
Improving Rehabilitation In Sarcopenia (IRIS)
A study testing Experimental product in people with Sarcopenia, run by Azienda di Servizi alla Persona di Pavia at 2 sites in Italy.
Trial summary
This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Experimental product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 2 sitesItaly
- Study dates
- 10 May 2017to 19 Dec 2018
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age 65 years or older
- admission for physical rehabilitation
- sarcopenia, measured with bioelectrical impedance assessment (BIA) + handgrip strength and gait speed
- Mini Mental State Examination ≥18
- Informed consent
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Refusal
Who cannot join
- Any malignant disease during the last five years
- Known kidney failure (previous glomerular filtration rate <30 ml/min);
- Known liver failure (Child B or C)
- Psychiatric disease
- Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
- Indications related to the study product:
Show all 9Show fewer
- More than 10 µg (400 IU) of daily Vitamin D intake from medical sources More than 500 mg of daily calcium intake from medical sources. Adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.
- Known allergy to milk, milk products or other components of the proposed interventions
- Indication to or ongoing artificial nutrition support
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia
Pavia, 27100
Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita, Azienda di Servizi alla Persona di Pavia
Pavia, 27100
About this study
Official title: A Whey Protein-based Nutritional Supplement Enriched in Vitamin D, Leucine and Calcium for Sarcopenia in Older Adults Undergoing Physical Rehabilitation the IRIS (Improving Rehabilitation In Sarcopenia) Study: a Randomized, Double-blind, Placebo-controlled Trial.
This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia
Read the detailed description
This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with whey protein, essential amino acids - mainly leucine - vitamin D and calcium concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia
- Conditions
- Sarcopenia
- Being tested
- Experimental product, Isocaloric placebo
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental productDietary supplement
Two servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.
Isocaloric placeboDietary supplement
Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Product | Experimental | Two servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers. Receives: Dietary Supplement: Experimental product |
| Isocaloric Placebo | Placebo comparator | Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water. Receives: Dietary Supplement: Isocaloric placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Change in gait speed (4-meter walking test)/month
Measured: 8 weeks
Secondary outcomes (13)
Physical performance - Tinetti
Change in Tinetti scale
Measured: 8 weeks
Physical performance - Timed Up and Go test
Change in timed up and go test
Measured: 8 weeks
Physical performance - chair-stand
chair-stand test
Measured: 8 weeks
Functional status - Barthel
Change in Barthel index score
Measured: 8 weeks
Functional status - ADL
Change in activities of daily living (ADL) score
Measured: 8 weeks
Functional status - handgrip strength
Change in handgrip strength
Measured: 8 weeks
Body weight
Change in body weight
Measured: 8 weeks
Muscle mass
Change in appendicular muscle mass
Measured: 8 weeks
Cognitive function - trail making test
Change in trail making test
Measured: 8 weeks
Cognitive function - Mini Mental State Examination
Change in Mini Mental State Examination
Measured: 8 weeks
Quality of life
Change in 12-item Short-Form Health Survey score (physical/mental components)
Measured: 8 weeks
Costs
Difference in costs of care (using lenght of stay and duration of rehabilitation as surrogate measures)
Measured: 8 weeks
Adverse events
Difference in rate of adverse events related to gastrointestinal intolerance
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start10 May 2017
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
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 SarcopeniaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariangela Rondanelli, Azienda di Servizi alla Persona di Pavia
- Investigators
- Mariangela Rondanelli, MD, PhD, Study director, Azienda di Servizi alla Persona di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120026
- Sponsor's protocol ID
- 20170011726
- Acronym
- IRIS
- Status last verified
- Jan 2019
- First submitted
- 14 Apr 2017
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rondanelli M, Cereda E, Klersy C, Faliva MA, Peroni G, Nichetti M, Gasparri C, Iannello G, Spadaccini D, Infantino V, Caccialanza R, Perna S. Improving rehabilitation in sarcopenia: a randomized-controlled trial utilizing a muscle-targeted food for special medical purposes. J Cachexia Sarcopenia Muscle. 2020 Dec;11(6):1535-1547. doi: 10.1002/jcsm.12532. Epub 2020 Sep 22.
PubMed 32961041
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Whey Protein-based Nutritional Supplement Enriched in Vitamin D, Leucine and Calcium for Sarcopenia in Older Adults Undergoing Physical Rehabilitation the IRIS (Improving Rehabilitation In Sarcopenia) Study: a Randomized, Double-blind, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT03120026
- Acronym / sponsor ID
- IRIS / 20170011726
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 19 Apr 2017 (actual)
- 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 randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia
Detailed description
This randomized, double-blind, placebo-controlled supplementation trial tested the hypothesis that nutritional supplementation with whey protein, essential amino acids - mainly leucine - vitamin D and calcium concurrent with regular, controlled physical activity would increase the efficacy of physical rehabilitation in old adults suffering from sarcopenia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Product | Experimental | Dietary Supplement: Experimental productTwo servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers. |
| Isocaloric Placebo | Placebo comparator | Dietary Supplement: Isocaloric placeboTwo servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- age 65 years or older
- admission for physical rehabilitation
- sarcopenia, measured with bioelectrical impedance assessment (BIA) + handgrip strength and gait speed
- Mini Mental State Examination ≥18
- Informed consent
Key exclusion criteria (9 listed)
- Any malignant disease during the last five years
- Known kidney failure (previous glomerular filtration rate <30 ml/min);
- Known liver failure (Child B or C)
- Psychiatric disease
- Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
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 |
|---|---|---|
| Experimental productTwo servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers. | Dietary supplement | Experimental Product |
| Isocaloric placeboTwo servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water. | Dietary supplement | Isocaloric Placebo |
Primary outcome
Gait speed
Time frame: 8 weeks
Change in gait speed (4-meter walking test)/month
13 secondary outcomes
Physical performance - Tinetti
Time frame: 8 weeks
Physical performance - Timed Up and Go test
Time frame: 8 weeks
Physical performance - chair-stand
Time frame: 8 weeks
Functional status - Barthel
Time frame: 8 weeks
Functional status - ADL
Time frame: 8 weeks
Functional status - handgrip strength
Time frame: 8 weeks
Body weight
Time frame: 8 weeks
Muscle mass
Time frame: 8 weeks
Cognitive function - trail making test
Time frame: 8 weeks
Cognitive function - Mini Mental State Examination
Time frame: 8 weeks
Quality of life
Time frame: 8 weeks
Costs
Time frame: 8 weeks
Adverse events
Time frame: 8 weeks
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 31 Jan 2019.
- Derived from this study: PubMed 32961041Rondanelli M, Cereda E, Klersy C, Faliva MA, Peroni G, Nichetti M, Gasparri C, Iannello G, Spadaccini D, Infantino V, Caccialanza R, Perna S. Improving rehabilitation in sarcopenia: a randomized-controlled trial utilizing a muscle-targeted food for special medical purposes. J Cachexia Sarcopenia Muscle. 2020 Dec;11(6):1535-1547. doi: 10.1002/jcsm.12532. Epub 2020 Sep 22.
- Individual participant dataSharing planned: Undecided
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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.
Mariangela Rondanelli, MD, PhD study director
Azienda di Servizi alla Persona di Pavia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental product in people with Sarcopenia, run by Azienda di Servizi alla Persona di Pavia at 2 sites in Italy.
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 7 inclusion and 9 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Gait speed (time frame: 8 weeks). 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 NCT03120026, 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 31 Jan 2019.