Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults

March 30, 2018 updated by: Johns Hopkins Bloomberg School of Public Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins School of Public Health 615 N. Wolfe St Room: E2537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI (Body Mass Index) under 19
  • Adult

Exclusion Criteria:

  • HIV/AIDS
  • Cancer
  • malabsorption disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess weight-gain efficacy following 8 weeks of dietary supplementation among malnourished adults.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare biochemical and immune markers before and following 8 weeks of treatment with dietary supplements.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Quaker Oats Company

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

August 31, 2007

First Submitted That Met QC Criteria

August 31, 2007

First Posted (Estimate)

September 3, 2007

Study Record Updates

Last Update Posted (Actual)

April 3, 2018

Last Update Submitted That Met QC Criteria

March 30, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00000428

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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