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
Study 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 January 16, 2009