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Protein-Energy MalnutritionPRO-PULSéNCT00135590

Evaluation of the Effectiveness of a Protein Pulse-Feeding Pattern in Elderly Patients

A study testing Protein pulse-feeding and Spread diet in people with Protein-Energy Malnutrition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The researchers tested the hypothesis that a protein pulse-feeding pattern was more efficient in improving muscle mass and immune functions than was a protein spread-feeding pattern, after 45 days, in elderly malnourished patients. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Protein-Energy Malnutrition
What is being tested?
Protein pulse-feeding and Spread diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteFrance
Study dates
Nov 2004to Oct 2007
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Must be malnourished
  • Hospitalization into a geriatric rehabilitation care unit
  • Age > 70 years
  • C-reactive protein (CRP) < 50 mg/l

Who cannot join

  • Enteral or parenteral nutrition
  • Renal, cardiac or digestive insufficiency
  • Diabetes
  • Pacemaker
  • Mini-Mental State (MMS) < 15

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Emile-Roux (AP-HP)

    Limeil-Brévannes, 94456

Other trials in France

About this study

The researchers tested the hypothesis that a protein pulse-feeding pattern was more efficient in improving muscle mass and immune functions than was a protein spread-feeding pattern, after 45 days, in elderly malnourished patients.

Read the detailed description

To estimate the amelioration of the accretion in protein and the immunizing deficit thanks to a nutrition "PULSEE" ( to hold on 80 % of the proteic by day in on meal) with a proteic distributed all along the day for old subjects having a denutrition

To also estimate that the diminution of the morbidity decrease (infections, bedsores) the average during the stay and the mortality according to 2 modalities of grip nutritional

Being tested
Protein pulse-feeding, Spread diet
Keywords
Protein pulse-feeding, Nutritional supplementation, Protein-energy malnutrition, Elderly subjects, Body composition
Medical subject headings
Protein-Energy Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Protein pulse-feedingDietary supplement

    Dietary protein (80% of daily intake) was consumed in one meal (12.00h)

  • Spread dietDietary supplement

    Dietary protein was spread over the four meals.

Study groups in NCT00135590
Study groupRoleWhat they receive
1ExperimentalProtein pulse-feeding
Receives: Dietary Supplement: Protein pulse-feeding
2Active comparatorSpread diet
Receives: Dietary Supplement: Spread diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA])

    Measured: 42 days

Secondary outcomes (6)

  1. Immune functions

    Measured: 42 days

  2. Hand-grip strength

    Measured: 42 days

  3. Biological nutritional parameters

    Measured: 42 days

  4. Mortality and morbidity (infections and bedsores)

    Measured: 42 days

  5. Activity of Daily Living (ADL)

    Measured: 42 days

  6. Plasmatic amino acid levels

    Measured: 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2005 (estimated)
  2. Study startNov 2004
  3. Study completionOct 2007

Resources

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
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00135590
Sponsor's protocol ID
PO30418
Other IDs
AOR03003
Acronym
PRO-PULSé
Status last verified
Nov 2004
First submitted
24 Aug 2005
Last updated
22 Nov 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • Bouillanne O, Neveux N, Nicolis I, Curis E, Cynober L, Aussel C. Long-lasting improved amino acid bioavailability associated with protein pulse feeding in hospitalized elderly patients: a randomized controlled trial. Nutrition. 2014 May;30(5):544-50. doi: 10.1016/j.nut.2013.10.006. Epub 2013 Oct 14.

    PubMed 24355438

  • Bouillanne O, Curis E, Hamon-Vilcot B, Nicolis I, Chretien P, Schauer N, Vincent JP, Cynober L, Aussel C. Impact of protein pulse feeding on lean mass in malnourished and at-risk hospitalized elderly patients: a randomized controlled trial. Clin Nutr. 2013 Apr;32(2):186-92. doi: 10.1016/j.clnu.2012.08.015. Epub 2012 Aug 30.

    PubMed 22992307

Questions about this trial

What is this clinical trial studying?

A study testing Protein pulse-feeding and Spread diet in people with Protein-Energy Malnutrition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 5 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 22 Nov 2007. 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 France. 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?

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?

Lean mass (dual energy X-ray absorptiometry [DEXA] and bioelectrical-impedance analysis [BIA]) (time frame: 42 days). 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 NCT00135590, which also lists 2 linked publications.

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 22 Nov 2007.

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