Developmental Adaptation to an Obesogenic Environment

October 3, 2014 updated by: Claudia Campbell, The University of The West Indies

Developmental Contribution to Macronutrient Selection and Appetite Control in Adult Survivors of Kwashiorkor and Marasmus

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Differences in birth weight between children with kwashiorkor (K) and marasmus (M) suggest that intrauterine factors influence the development of these two syndromes of severe acute malnutrition (SAM). Such an effect could play a role in setting specific targets for dietary protein that has been proposed to influence total energy intake (TEI), body weight and risk of obesity.

We recruited 63 adult survivors of SAM, aged 17 to 46 years, who in childhood had been treated at the Tropical Metabolism Research Unit (TMRU) Metabolic Ward. Data on birth weight, age, weight and length at admission were abstracted from TMRU records. Subjects provided written informed consent. The study was approved by the Faculty of Medical Sciences Ethics Committee, University of the West Indies.

Measurements were conducted in two phases. All subjects were seen in single-sex pairs and stayed in a dedicated metabolic suite for 9 consecutive days. During phase 1 (days 1 to 3- choice experiment) they ate freely at each mealtime from menus comprising a combination of foods containing different percentages of energy as protein (PEP), set at 10%, 15% or 25% (26). During phase 2 (days 4 to 8), pairs were randomized to one of three groups each of which received only foods that contained 10%, 15% or 25% PEP. The participants were blinded to the treatment. Participants were taken for a 1-hour supervised walk each day at 4 pm.

Thirty-one local recipes of 10 sweet and 21 savoury foods were selected. Each was modified into three recipes containing 10, 15 or 25% energy as protein through the addition of food ingredients, a protein mix and/or maltodextrin (Ross Nutrition). Carbohydrate was adjusted to be 60, 55 or 45% energy and dietary fat was kept constant at 30%. The PEP versions of each food/recipe were taste tested for the ability to determine the protein concentration of any dish due to appearance, smell or texture as well as for pleasantness. If taste testers were able to detect any difference, the recipes were adjusted and retested until no difference was detected. Up to 11 foods were provided on each day during the 8-day period, giving participants both variety and choice at all times as indicated in table 1. During the first three days (phase 1), three food items other than fruit and vegetable salads and tea were offered at breakfast, lunch and dinner to all the participants. These three food items at each of these meal times included foods containing 10%, 15% or 25% protein energy. From days 4 to 8 (phase 2), these same daily food types were repeated every three days but the foods contained 10 PEP in one group, in another group they all contained 15 PEP, and in the third group they all contained 25 PEP protein.

Breakfast was provided at 8 am, lunch at 12:30 pm and dinner at 6 pm. During both phases snack items were made freely available at all times. The amount eaten was determined by weighing each food item before consumption and any not eaten to the nearest gram. The foods were served in weighed quantities on tared containers. Plates were of a single design and neutral (white) color. The same size, style and color plates were used for the 10, 15 and 25 PEP version of each food. Participants were offered optional foods including 100g fruit salad, and decaffeinated tea sweetened with a measured amount of brown sugar with breakfast, and 100g vegetable salad with lunch and dinner. A three-day food diary completed prior to the 8 day ad libitum test period and foods consumed during the test period were analysed for total energy, protein, carbohydrate and fat content.

The weight of the subjects without shoes and in light clothing was measured daily to the nearest 0.1 kg; height was measured to the nearest 0.1 cm. Fat and fat-free mass were obtained from DEXA measurements. Weight gain was calculated from day 1 to 4 in phase 1 and from day 4 to 8 in phase 2.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

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

17 years to 46 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes, hypertension, pregnancy,

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 % Protein
10% Dietary protein energy

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

Other Names:
  • macronutrient
Experimental: 15% Protein
15% Dietary protein energy

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

Other Names:
  • macronutrient
Experimental: 25% Protein
25% Dietary protein energy

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

Other Names:
  • macronutrient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy intake (Protein leverage)
Time Frame: 5 days
Total energy intake when placed on 10, 15 or 25% protein energy diet
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change
Time Frame: 5 days
over 5 days of consuming diets containing either 10, 15 or 25% protein energy
5 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protein intake (protein target)
Time Frame: 3 days
protein intake when participants ate freely from menus comprising a combination of foods containing 10, 15 and 25% protein energy
3 days

Collaborators and Investigators

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

Investigators

  • Study Director: Terrence G Forrester, MBBS, PhD, University of the West Indies, mona
  • Principal Investigator: David Raubenheimer, PhD, University of Aukland
  • Principal Investigator: Claudia P Campbell, PhD, University of the West Indies, mona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

May 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 1, 2014

First Submitted That Met QC Criteria

October 3, 2014

First Posted (Estimate)

October 6, 2014

Study Record Updates

Last Update Posted (Estimate)

October 6, 2014

Last Update Submitted That Met QC Criteria

October 3, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • ECP 71, 2008/2009

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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