Effectiveness of Quaker Complete Nutrition Supplements fo... | NCT00523900

Studies
Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults

NCT00523900

Sponsor

Johns Hopkins Bloomberg School of Public Health

Status

Completed

Last Update Posted

Apr 3, 2018Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Malnutrition

Interventions

Quaker Complete Nutrition Supplements

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Not provided

Completion Date

Dec 2008Actual

First Submitted Date

Aug 31, 2007

First Submission Date that Met QC Criteria

Aug 31, 2007

First Posted Date

Sep 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2018

Last Update Posted Date

Apr 3, 2018Actual

Name	Class
Quaker Oats Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Malnourished adults who will be given a dietary supplement.	Dietary Supplement: Quaker Complete Nutrition Supplements

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quaker Complete Nutrition Supplements	Dietary Supplement	3-6 250ml cans of Quaker Complete Nutrition Supplements per day	Experimental

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI (Body Mass Index) under 19
Adult

Exclusion Criteria:

HIV/AIDS
Cancer
malabsorption disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lawrence Cheskin, M.D	Johns Hopkins Bloomberg School of Public Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins School of Public Health 615 N. Wolfe St Room: E2537		Baltimore	Maryland	21205	United States

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition
D013851	Thinness

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided