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Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults

This study is currently recruiting participants.
Verified by Johns Hopkins Bloomberg School of Public Health, August 2007

Sponsors and Collaborators: Johns Hopkins Bloomberg School of Public Health
Standard Food Incorporated and Quaker Oats
Information provided by: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00523900
  Purpose

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 Intervention
Malnutrition
Dietary Supplement: Quaker Complete Nutrition Supplements

MedlinePlus related topics:   Dietary Supplements   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

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

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

Estimated Enrollment:   40
Study Start Date:   August 2007
Estimated Study Completion Date:   June 2008

Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • BMI (Body Mass Index) under 19
  • Adult

Exclusion Criteria:

  • HIV/AIDS
  • Cancer
  • malabsorption disorder
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523900

Contacts
Contact: Jennifer Noll, R.D     440-241-7878410     jnoll@jhsph.edu    
Contact: Lawrence Cheskin, M.D     410-583-2868     lcheski1@jhmi.edu    

Locations
United States, Maryland
Johns Hopkins School of Public Health 615 N. Wolfe St Room: E2537     Recruiting
      Baltimore, Maryland, United States, 21205
      Principal Investigator: Lawrence Cheskin, M.D            

Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Standard Food Incorporated and Quaker Oats

Investigators
Principal Investigator:     Lawrence Cheskin, M.D     Johns Hopkins Bloomberg School of Public Health    
  More Information


Study ID Numbers:   IRB00000428
First Received:   August 31, 2007
Last Updated:   August 31, 2007
ClinicalTrials.gov Identifier:   NCT00523900
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Body Weight
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on October 10, 2008




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