NCT00523900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

First QC Date

August 31, 2007

Last Update Submit

March 30, 2018

Conditions

Malnutrition

Keywords

malnutritionunderweightlow body weightBMI under 19under nourishedmalnourished

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (1)

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

    8 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

Malnourished adults who will be given a dietary supplement.

Dietary Supplement: Quaker Complete Nutrition Supplements

Interventions

Quaker Complete Nutrition SupplementsDIETARY_SUPPLEMENT

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

Experimental

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI (Body Mass Index) under 19
  • Adult

You may not qualify if:

  • HIV/AIDS
  • Cancer
  • malabsorption disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

MalnutritionThinness

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lawrence Cheskin, M.D

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2007

First Posted

September 3, 2007

Study Start

August 1, 2007

Study Completion

December 1, 2008

Last Updated

April 3, 2018

Record last verified: 2018-03

Locations

US(1)