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Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults

This study has been completed.
Sponsor:
Collaborator:
Standard Food Incorporated and Quaker Oats
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00523900
First received: August 31, 2007
Last updated: October 19, 2009
Last verified: August 2007
  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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare biochemical and immune markers before and following 8 weeks of treatment with dietary supplements. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2007
Study Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Standard Food Incorporated and Quaker Oats
Investigators
Principal Investigator: Lawrence Cheskin, M.D Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: Johns Hopkins School of Public Health
ClinicalTrials.gov Identifier: NCT00523900     History of Changes
Other Study ID Numbers: IRB00000428
Study First Received: August 31, 2007
Last Updated: October 19, 2009
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

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on November 25, 2014