Nutrition Disorders in Old AgePhase 3NCT03588897
The Impact of Oral Nutritional Supplements on the Nutritional Status of Elderly Patients
A Phase 3 study testing Nutridrink Multi Fibre in people with Nutrition Disorders in Old Age and Nutritional Supplement Toxicity, run by Radoslaw Pach, MD, Ph D.
Trial summary
The study compares nutritional status of two groups elderly patient aged 65 and more. One group of the patients received nutritional support (Nutridrink Multi Fibre) for 14 days. Nutritional status of the patients were compared 2 months after the start of the intervention. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nutrition Disorders in Old Age, Nutritional Supplement Toxicity, Elderly Infection
- What is being tested?
- Nutridrink Multi Fibre
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2018
- Phase
- Phase 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age > 65 and general status which enables compliance with study requirements
- Barthel's scale (Barthel scale = Barthel ADL index - an ordinal scale used to measure performance in activities of daily living) points 21-100
- MMSE (Mini Mental State Examination) points 24-30
- no use of laxatives
Who cannot join
- lack of consent
- neoplasms
- previous enteral nutrition
- Barthel's scale 0-20
- MMSE points 0-23
- BMI > 25
- laxatives
About this study
Official title: The Impact of Oral Nutritional Supplements on the Nutritional Status of the Elderly - Randomised Clinical Trial.
The study compares nutritional status of two groups elderly patient aged 65 and more. One group of the patients received nutritional support (Nutridrink Multi Fibre) for 14 days. Nutritional status of the patients were compared 2 months after the start of the intervention.
Read the detailed description
The aim of the study was to compare nutritional status of two groups of elderly patients (> 65 years old). Total of 120 patients were randomly assigned into two groups. One group received normal diet whereas the second group received 300 kcal nutritional support (Nutridrink Multi Fibre 2x100 ml) between meals for 14 days. Two months after start of the intervention following examinations were performed:
- functional status of the patient (Barthel's scale, MMSE scale)
- nutritional status based on: weight, height, BMI; Mini Nutritional Assessment, plasma concentration of prealbumin, albumin, transferrin, total lymphocyte count.
The clinical status of the patient was evaluated based on clinical data on different organ infections. In addition costs of supplementary nutrition were taken into consideration.
- Being tested
- Nutridrink Multi Fibre
- Keywords
- nutritional status, Nutridrink, elderly nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutridrink Multi FibreDietary supplement
Dietary supplementation of 300 kcal for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Normal Diet | No intervention | Elderly patients receiving normal diet |
| Nutritional Support | Experimental | Elderly patients receiving normal diet with nutritional support (Nutridrink Multi Fibre 2x100 ml per day) Receives: Dietary Supplement: Nutridrink Multi Fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI of the elderly patients
BMI two months after start of the intervention
Measured: 2 months
Prealbumin plasma concentration
Prealbumin concentration two months after start of the intervention
Measured: 2 months
Albumin plasma concentration
Albumin concentration two months after start of the intervention
Measured: 2months
Transferrin plasma concentration
Transferrin concentration two months after start of the intervention
Measured: 2 months
TLC
Total lymphocyte count two months after start of the intervention
Measured: 2 months
Secondary outcomes (4)
Organ infections
Infection in any organ based on clinical data
Measured: 2 months
Complications
Any complications associated with nutritional support
Measured: 2 months
Functional status of the patient - Barthel's scale
Scores in Barthel's scale two months after start of the intervention
Measured: 2 months
Functional status of the patient - MMSE scale
Scores in MMSE scale two months after start of the intervention
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study startJan 2014
- Primary completionDec 2016
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition Disorders in Old AgeStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Normal diet versus normal diet + nutritional support in elderly patients
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radoslaw Pach, MD, Ph D
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Radoslaw Pach, MD, Ph D, Jagiellonian University
- Investigators
- Lucyna Scislo, MD PhD, Principal investigator, Department of Clinical Nursery, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588897
- Sponsor's protocol ID
- Nutrition in Elderly RCT
- Status last verified
- Jul 2018
- First submitted
- 1 Jul 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Oral Nutritional Supplements on the Nutritional Status of the Elderly - Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT03588897
- Acronym / sponsor ID
- Nutrition in Elderly RCT
- Keywords
- nutritional status, Nutridrink, elderly nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Radoslaw Pach, MD, Ph DUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 17 Jul 2018 (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.
The study compares nutritional status of two groups elderly patient aged 65 and more. One group of the patients received nutritional support (Nutridrink Multi Fibre) for 14 days. Nutritional status of the patients were compared 2 months after the start of the intervention.
Detailed description
The aim of the study was to compare nutritional status of two groups of elderly patients (> 65 years old). Total of 120 patients were randomly assigned into two groups. One group received normal diet whereas the second group received 300 kcal nutritional support (Nutridrink Multi Fibre 2x100 ml) between meals for 14 days. Two months after start of the intervention following examinations were performed:
- functional status of the patient (Barthel's scale, MMSE scale)
- nutritional status based on: weight, height, BMI; Mini Nutritional Assessment, plasma concentration of prealbumin, albumin, transferrin, total lymphocyte count.
The clinical status of the patient was evaluated based on clinical data on different organ infections. In addition costs of supplementary nutrition were taken into consideration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Normal diet versus normal diet + nutritional support in elderly patients
| Arm | Type | Receives |
|---|---|---|
| Normal Diet | No intervention | –Elderly patients receiving normal diet |
| Nutritional Support | Experimental | Dietary Supplement: Nutridrink Multi FibreElderly patients receiving normal diet with nutritional support (Nutridrink Multi Fibre 2x100 ml per day) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- age > 65 and general status which enables compliance with study requirements
- Barthel's scale (Barthel scale = Barthel ADL index - an ordinal scale used to measure performance in activities of daily living) points 21-100
- MMSE (Mini Mental State Examination) points 24-30
- no use of laxatives
Key exclusion criteria (7 listed)
- lack of consent
- neoplasms
- previous enteral nutrition
- Barthel's scale 0-20
- MMSE points 0-23
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 |
|---|---|---|
| Nutridrink Multi FibreDietary supplementation of 300 kcal for 14 days | Dietary supplement | Nutritional Support |
Primary outcome
BMI of the elderly patients
Time frame: 2 months
BMI two months after start of the intervention
Prealbumin plasma concentration
Time frame: 2 months
Prealbumin concentration two months after start of the intervention
Albumin plasma concentration
Time frame: 2months
Albumin concentration two months after start of the intervention
Transferrin plasma concentration
Time frame: 2 months
Transferrin concentration two months after start of the intervention
TLC
Time frame: 2 months
Total lymphocyte count two months after start of the intervention
4 secondary outcomes
Organ infections
Time frame: 2 months
Complications
Time frame: 2 months
Functional status of the patient - Barthel's scale
Time frame: 2 months
Functional status of the patient - MMSE scale
Time frame: 2 months
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 17 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Lucyna Scislo, MD PhD principal investigator
Department of Clinical Nursery, Jagiellonian University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nutridrink Multi Fibre in people with Nutrition Disorders in Old Age and Nutritional Supplement Toxicity, run by Radoslaw Pach, MD, Ph D.
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 4 inclusion and 7 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
BMI of the elderly patients (time frame: 2 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2018.