MalnutritionProMONCT02683720
Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly
A study testing ONS in people with Malnutrition and Muscle Health, run by Wageningen University at 1 site in Netherlands.
Trial summary
ProMO aims to investigate the effectiveness of a newly developed ONS in increasing body weight, muscle mass and function in malnourished elderly compared to standard care. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Muscle Health
- What is being tested?
- ONS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2016to Dec 2017
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 65+
- at risk of malnutrition/ malnourished
Who cannot join
- • Mental status that is incompatible with the proper conduct of the study
- Illness of such severity that life expectancy is considered to be less than 12 months
- Use of diabetes medication (e.g. insulin, methformin)
- Use of an oral nutritional supplement in the previous three months
- Participating in any regular exercise training program (≥2h/w)
- Renal insufficiency (eGFR <30 mL/min/1.73 m2)
Show all 19Show fewer
- Unstable organ failure or organ failure necessitating a special diet
- Chronic corticosteroids use
- Recent (previous 2 months) use of antibiotics
- Recent (previous 3 months) change in habitual medication use (e.g statins and thyroxin)
- Recent blood donation (<1 month prior to Day 01 of the study)
- Not willing or afraid to give blood during the study
- Allergic or sensitive for milk proteins
- Reported vegan or macrobiotic life-style
- Drug and/or alcohol abuse (current consumption of more than 21 alcoholic drinks per week)
- Individual unable to give informed consent
- Current participation in other research from the Division of Human Nutrition
- Not having a general practitioner
- Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Wageningen University
Wageningen
Pol Grootswagers, Msc, pol.grootswagers@wur.nl
Lisette de Groot, Prof. Dr.
About this study
ProMO aims to investigate the effectiveness of a newly developed ONS in increasing body weight, muscle mass and function in malnourished elderly compared to standard care.
- Conditions
- Malnutrition, Muscle Health
- Being tested
- ONS
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONSDietary supplement
randomized clinical trial involving different ONS strategies
| Study group | Role | What they receive |
|---|---|---|
| ONS1 | Experimental | new product Receives: Dietary Supplement: ONS |
| ONS2 | Active comparator | usual care Receives: Dietary Supplement: ONS |
What is being measured
The primary outcome is the main question the study is designed to answer.
lean body mass
Measured: 12 weeks
Secondary outcomes (1)
body weight
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
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 MalnutritionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Vitalnext
- Responsible party
- Principal investigator, Lisette de Groot, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683720
- Sponsor's protocol ID
- NL56873.081.16
- Acronym
- ProMO
- Status last verified
- Jul 2016
- First submitted
- 12 Feb 2016
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Grootswagers P, Smeets E, Oteng AB, Groot L. A novel oral nutritional supplement improves gait speed and mitochondrial functioning compared to standard care in older adults with (or at risk of) undernutrition: results from a randomized controlled trial. Aging (Albany NY). 2021 Apr 2;13(7):9398-9418. doi: 10.18632/aging.202912. Epub 2021 Apr 2.
PubMed 33799307
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly
- ClinicalTrials.gov ID
- NCT02683720
- Acronym / sponsor ID
- ProMO / NL56873.081.16
- Conditions
- Malnutrition, Muscle Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Vitalnext
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Feb 2016 (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.
ProMO aims to investigate the effectiveness of a newly developed ONS in increasing body weight, muscle mass and function in malnourished elderly compared to standard care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONS1 | Experimental | Dietary Supplement: ONSnew product |
| ONS2 | Active comparator | Dietary Supplement: ONSusual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- age 65+
- at risk of malnutrition/ malnourished
Key exclusion criteria (19 listed)
- • Mental status that is incompatible with the proper conduct of the study
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 |
|---|---|---|
| ONSrandomized clinical trial involving different ONS strategies | Dietary supplement | ONS1, ONS2 |
Primary outcome
lean body mass
Time frame: 12 weeks
1 secondary outcome
body weight
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- Derived from this study: PubMed 33799307Grootswagers P, Smeets E, Oteng AB, Groot L. A novel oral nutritional supplement improves gait speed and mitochondrial functioning compared to standard care in older adults with (or at risk of) undernutrition: results from a randomized controlled trial. Aging (Albany NY). 2021 Apr 2;13(7):9398-9418. doi: 10.18632/aging.202912. Epub 2021 Apr 2.
- Individual participant dataSharing planned: No
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONS in people with Malnutrition and Muscle Health, run by Wageningen University at 1 site in Netherlands.
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 2 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 21 Jul 2016. 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 Netherlands. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lean body mass (time frame: 12 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 NCT02683720, 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 21 Jul 2016.