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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00523900
Other study ID # IRB00000428
Secondary ID
Status Completed
Phase N/A
First received August 31, 2007
Last updated March 30, 2018
Start date August 2007
Est. completion date December 2008

Study information

Verified date March 2018
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria:

- BMI (Body Mass Index) under 19

- Adult

Exclusion Criteria:

- HIV/AIDS

- Cancer

- malabsorption disorder

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Quaker Complete Nutrition Supplements
3-6 250ml cans of Quaker Complete Nutrition Supplements per day

Locations

Country Name City State
United States Johns Hopkins School of Public Health 615 N. Wolfe St Room: E2537 Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health Quaker Oats Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess weight-gain efficacy following 8 weeks of dietary supplementation among malnourished adults. 8 weeks
Secondary To compare biochemical and immune markers before and following 8 weeks of treatment with dietary supplements. 8 weeks
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