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Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quaker Complete Nutrition Supplements
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring malnutrition, underweight, low body weight, BMI under 19, under nourished, malnourished

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI (Body Mass Index) under 19
  • Adult

Exclusion Criteria:

  • HIV/AIDS
  • Cancer
  • malabsorption disorder

Sites / Locations

  • Johns Hopkins School of Public Health 615 N. Wolfe St Room: E2537

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Malnourished adults who will be given a dietary supplement.

Outcomes

Primary Outcome Measures

To assess weight-gain efficacy following 8 weeks of dietary supplementation among malnourished adults.

Secondary Outcome Measures

To compare biochemical and immune markers before and following 8 weeks of treatment with dietary supplements.

Full Information

First Posted
August 31, 2007
Last Updated
March 30, 2018
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Quaker Oats Company
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1. Study Identification

Unique Protocol Identification Number
NCT00523900
Brief Title
Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults
Official Title
Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Quaker Oats Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
malnutrition, underweight, low body weight, BMI under 19, under nourished, malnourished

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Malnourished adults who will be given a dietary supplement.
Intervention Type
Dietary Supplement
Intervention Name(s)
Quaker Complete Nutrition Supplements
Intervention Description
3-6 250ml cans of Quaker Complete Nutrition Supplements per day
Primary Outcome Measure Information:
Title
To assess weight-gain efficacy following 8 weeks of dietary supplementation among malnourished adults.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
To compare biochemical and immune markers before and following 8 weeks of treatment with dietary supplements.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI (Body Mass Index) under 19 Adult Exclusion Criteria: HIV/AIDS Cancer malabsorption disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Cheskin, M.D
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Public Health 615 N. Wolfe St Room: E2537
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

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