MalnutritionNCT00523900
Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults
A study testing Quaker Complete Nutrition Supplements in people with Malnutrition, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
Intervention study in malnourished adults to assess whether a nutritional supplement given for 8 weeks in addition to the subject's usual diet improves body weight, body composition, biochemical and immune parameters. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Quaker Complete Nutrition Supplements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2008
- 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 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI (Body Mass Index) under 19
- Adult
Who cannot join
- HIV/AIDS
- Cancer
- malabsorption disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Public Health 615 N. Wolfe St Room: E2537
Baltimore, Maryland, 21205
About this study
Intervention study in malnourished adults to assess whether a nutritional supplement given for 8 weeks in addition to the subject's usual diet improves body weight, body composition, biochemical and immune parameters.
Read the detailed description
Criteria to be included in this study include:
BMI (Body Mass Index) under 19 Free of cancer, HIV/AIDS, bulimia/anorexia and any malabsorption disorders
Description:
We are studying whether adding nutritional shakes will help participants gain weight and improve their health and immunity. This study lasts about 8 weeks and has a total of 7 visits.
- Conditions
- Malnutrition
- Being tested
- Quaker Complete Nutrition Supplements
- Keywords
- malnutrition, underweight, low body weight, BMI under 19, under nourished, malnourished
- Medical subject headings
- Malnutrition, Thinness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quaker Complete Nutrition SupplementsDietary supplement
3-6 250ml cans of Quaker Complete Nutrition Supplements per day
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Malnourished adults who will be given a dietary supplement. Receives: Dietary Supplement: Quaker Complete Nutrition Supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess weight-gain efficacy following 8 weeks of dietary supplementation among malnourished adults.
Measured: 8 weeks
Secondary outcomes (1)
To compare biochemical and immune markers before and following 8 weeks of treatment with dietary supplements.
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 posted3 Sep 2007 (estimated)
- Study startAug 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Quaker Oats Company
- Responsible party
- Sponsor
- Investigators
- Lawrence Cheskin, M.D, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523900
- Sponsor's protocol ID
- IRB00000428
- Status last verified
- Mar 2018
- First submitted
- 31 Aug 2007
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults
- ClinicalTrials.gov ID
- NCT00523900
- Acronym / sponsor ID
- IRB00000428
- Conditions
- Malnutrition
- Keywords
- malnutrition, underweight, low body weight, BMI under 19, under nourished, malnourished
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Quaker Oats Company
- Study start
- Aug 2007
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Sep 2007 (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.
Intervention study in malnourished adults to assess whether a nutritional supplement given for 8 weeks in addition to the subject's usual diet improves body weight, body composition, biochemical and immune parameters.
Detailed description
Criteria to be included in this study include:
BMI (Body Mass Index) under 19 Free of cancer, HIV/AIDS, bulimia/anorexia and any malabsorption disorders
Description:
We are studying whether adding nutritional shakes will help participants gain weight and improve their health and immunity. This study lasts about 8 weeks and has a total of 7 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Quaker Complete Nutrition SupplementsMalnourished adults who will be given a dietary supplement. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI (Body Mass Index) under 19
- Adult
Key exclusion criteria (3 listed)
- HIV/AIDS
- Cancer
- malabsorption disorder
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 |
|---|---|---|
| Quaker Complete Nutrition Supplements3-6 250ml cans of Quaker Complete Nutrition Supplements per day | Dietary supplement | Experimental |
Primary outcome
To assess weight-gain efficacy following 8 weeks of dietary supplementation among malnourished adults.
Time frame: 8 weeks
1 secondary outcome
To compare biochemical and immune markers before and following 8 weeks of treatment with dietary supplements.
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 3 Apr 2018.
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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.
Lawrence Cheskin, M.D principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quaker Complete Nutrition Supplements in people with Malnutrition, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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 3 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 3 Apr 2018. 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 United States. 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?
To assess weight-gain efficacy following 8 weeks of dietary supplementation among malnourished adults. (time frame: 8 weeks). 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 3 Apr 2018.