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Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults

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ClinicalTrials.gov Identifier: NCT00523900
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Quaker Oats Company
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief 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.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: Quaker Complete Nutrition Supplements Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults
Study Start Date : August 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
Malnourished adults who will be given a dietary supplement.
Dietary Supplement: Quaker Complete Nutrition Supplements
3-6 250ml cans of Quaker Complete Nutrition Supplements per day




Primary Outcome Measures :
  1. To assess weight-gain efficacy following 8 weeks of dietary supplementation among malnourished adults. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. To compare biochemical and immune markers before and following 8 weeks of treatment with dietary supplements. [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI (Body Mass Index) under 19
  • Adult

Exclusion Criteria:

  • HIV/AIDS
  • Cancer
  • malabsorption disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523900


Locations
United States, Maryland
Johns Hopkins School of Public Health 615 N. Wolfe St Room: E2537
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Quaker Oats Company
Investigators
Principal Investigator: Lawrence Cheskin, M.D Johns Hopkins Bloomberg School of Public Health

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00523900     History of Changes
Other Study ID Numbers: IRB00000428
First Posted: September 3, 2007    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
malnutrition
underweight
low body weight
BMI under 19
under nourished
malnourished

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders