NCT02257593

Brief Summary

The purpose of this study was to evaluate whether birth weight is related to the demand for dietary protein in adult survivors of severe acute malnutrition (Kwashiorkor and Marasmus), and that leveraging of protein intake is associated with total energy intake and weight change in the survivors consuming foods with different percentages of energy as protein (PEP).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2009

Typical duration for not_applicable obesity

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2014

Completed
Last Updated

October 6, 2014

Status Verified

October 1, 2014

Enrollment Period

3.1 years

First QC Date

October 1, 2014

Last Update Submit

October 3, 2014

Conditions

Keywords

macronutrientmalnutritionbirth weightprotein leverage

Outcome Measures

Primary Outcomes (1)

  • Energy intake (Protein leverage)

    Total energy intake when placed on 10, 15 or 25% protein energy diet

    5 days

Secondary Outcomes (1)

  • Weight change

    5 days

Other Outcomes (1)

  • Protein intake (protein target)

    3 days

Study Arms (3)

10 % Protein

EXPERIMENTAL

10% Dietary protein energy

Other: Dietary protein

15% Protein

EXPERIMENTAL

15% Dietary protein energy

Other: Dietary protein

25% Protein

EXPERIMENTAL

25% Dietary protein energy

Other: Dietary protein

Interventions

Persons were fed Participants were randomized to one of three arms, each of which received 10%, 15% or 25% of total energy derived from protein

Also known as: macronutrient
10 % Protein15% Protein25% Protein

Eligibility Criteria

Age17 Years - 46 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adults who were treated for severe childhood malnutrition at the Tropical Metabolism Research Unit

You may not qualify if:

  • Diabetes, hypertension, pregnancy,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Gosby AK, Soares-Wynter S, Campbell C, Badaloo A, Antonelli M, Hall RM, Martinez-Cordero C, Jebb SA, Brand-Miller J, Caterson ID, Conigrave AD, Forrester TG, Raubenheimer D, Simpson SJ. Design and testing of foods differing in protein to energy ratios. Appetite. 2010 Oct;55(2):367-70. doi: 10.1016/j.appet.2010.06.009. Epub 2010 Jun 19.

    PMID: 20600416BACKGROUND
  • Forrester TE, Badaloo AV, Boyne MS, Osmond C, Thompson D, Green C, Taylor-Bryan C, Barnett A, Soares-Wynter S, Hanson MA, Beedle AS, Gluckman PD. Prenatal factors contribute to the emergence of kwashiorkor or marasmus in severe undernutrition: evidence for the predictive adaptation model. PLoS One. 2012;7(4):e35907. doi: 10.1371/journal.pone.0035907. Epub 2012 Apr 30.

    PMID: 22558267BACKGROUND

MeSH Terms

Conditions

ObesityMalnutritionBirth Weight

Interventions

Dietary ProteinsNutrients

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Terrence G Forrester, MBBS, PhD

    University of the West Indies, Mona

    STUDY DIRECTOR
  • David Raubenheimer, PhD

    University of Aukland

    PRINCIPAL INVESTIGATOR
  • Claudia P Campbell, PhD

    University of the West Indies, Mona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Claudia Patricia Campbell

Study Record Dates

First Submitted

October 1, 2014

First Posted

October 6, 2014

Study Start

May 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

October 6, 2014

Record last verified: 2014-10