<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02257593</url>
  </required_header>
  <id_info>
    <org_study_id>ECP 71, 2008/2009</org_study_id>
    <nct_id>NCT02257593</nct_id>
  </id_info>
  <brief_title>Developmental Adaptation to an Obesogenic Environment</brief_title>
  <official_title>Developmental Contribution to Macronutrient Selection and Appetite Control in Adult Survivors of Kwashiorkor and Marasmus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of The West Indies</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Auckland, New Zealand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of The West Indies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate whether birth weight is related to the demand for&#xD;
      dietary protein in adult survivors of severe acute malnutrition (Kwashiorkor and Marasmus),&#xD;
      and that leveraging of protein intake is associated with total energy intake and weight&#xD;
      change in the survivors consuming foods with different percentages of energy as protein&#xD;
      (PEP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Differences in birth weight between children with kwashiorkor (K) and marasmus (M) suggest&#xD;
      that intrauterine factors influence the development of these two syndromes of severe acute&#xD;
      malnutrition (SAM). Such an effect could play a role in setting specific targets for dietary&#xD;
      protein that has been proposed to influence total energy intake (TEI), body weight and risk&#xD;
      of obesity.&#xD;
&#xD;
      We recruited 63 adult survivors of SAM, aged 17 to 46 years, who in childhood had been&#xD;
      treated at the Tropical Metabolism Research Unit (TMRU) Metabolic Ward. Data on birth weight,&#xD;
      age, weight and length at admission were abstracted from TMRU records. Subjects provided&#xD;
      written informed consent. The study was approved by the Faculty of Medical Sciences Ethics&#xD;
      Committee, University of the West Indies.&#xD;
&#xD;
      Measurements were conducted in two phases. All subjects were seen in single-sex pairs and&#xD;
      stayed in a dedicated metabolic suite for 9 consecutive days. During phase 1 (days 1 to 3-&#xD;
      choice experiment) they ate freely at each mealtime from menus comprising a combination of&#xD;
      foods containing different percentages of energy as protein (PEP), set at 10%, 15% or 25%&#xD;
      (26). During phase 2 (days 4 to 8), pairs were randomized to one of three groups each of&#xD;
      which received only foods that contained 10%, 15% or 25% PEP. The participants were blinded&#xD;
      to the treatment. Participants were taken for a 1-hour supervised walk each day at 4 pm.&#xD;
&#xD;
      Thirty-one local recipes of 10 sweet and 21 savoury foods were selected. Each was modified&#xD;
      into three recipes containing 10, 15 or 25% energy as protein through the addition of food&#xD;
      ingredients, a protein mix and/or maltodextrin (Ross Nutrition). Carbohydrate was adjusted to&#xD;
      be 60, 55 or 45% energy and dietary fat was kept constant at 30%. The PEP versions of each&#xD;
      food/recipe were taste tested for the ability to determine the protein concentration of any&#xD;
      dish due to appearance, smell or texture as well as for pleasantness. If taste testers were&#xD;
      able to detect any difference, the recipes were adjusted and retested until no difference was&#xD;
      detected. Up to 11 foods were provided on each day during the 8-day period, giving&#xD;
      participants both variety and choice at all times as indicated in table 1. During the first&#xD;
      three days (phase 1), three food items other than fruit and vegetable salads and tea were&#xD;
      offered at breakfast, lunch and dinner to all the participants. These three food items at&#xD;
      each of these meal times included foods containing 10%, 15% or 25% protein energy. From days&#xD;
      4 to 8 (phase 2), these same daily food types were repeated every three days but the foods&#xD;
      contained 10 PEP in one group, in another group they all contained 15 PEP, and in the third&#xD;
      group they all contained 25 PEP protein.&#xD;
&#xD;
      Breakfast was provided at 8 am, lunch at 12:30 pm and dinner at 6 pm. During both phases&#xD;
      snack items were made freely available at all times. The amount eaten was determined by&#xD;
      weighing each food item before consumption and any not eaten to the nearest gram. The foods&#xD;
      were served in weighed quantities on tared containers. Plates were of a single design and&#xD;
      neutral (white) color. The same size, style and color plates were used for the 10, 15 and 25&#xD;
      PEP version of each food. Participants were offered optional foods including 100g fruit&#xD;
      salad, and decaffeinated tea sweetened with a measured amount of brown sugar with breakfast,&#xD;
      and 100g vegetable salad with lunch and dinner. A three-day food diary completed prior to the&#xD;
      8 day ad libitum test period and foods consumed during the test period were analysed for&#xD;
      total energy, protein, carbohydrate and fat content.&#xD;
&#xD;
      The weight of the subjects without shoes and in light clothing was measured daily to the&#xD;
      nearest 0.1 kg; height was measured to the nearest 0.1 cm. Fat and fat-free mass were&#xD;
      obtained from DEXA measurements. Weight gain was calculated from day 1 to 4 in phase 1 and&#xD;
      from day 4 to 8 in phase 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Energy intake (Protein leverage)</measure>
    <time_frame>5 days</time_frame>
    <description>Total energy intake when placed on 10, 15 or 25% protein energy diet</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight change</measure>
    <time_frame>5 days</time_frame>
    <description>over 5 days of consuming diets containing either 10, 15 or 25% protein energy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Protein intake (protein target)</measure>
    <time_frame>3 days</time_frame>
    <description>protein intake when participants ate freely from menus comprising a combination of foods containing 10, 15 and 25% protein energy</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>10 % Protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10% Dietary protein energy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>15% Protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15% Dietary protein energy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>25% Protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25% Dietary protein energy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary protein</intervention_name>
    <description>Persons were fed&#xD;
Participants were randomized to one of three arms, each of which received 10%, 15% or 25% of total energy derived from protein</description>
    <arm_group_label>10 % Protein</arm_group_label>
    <arm_group_label>15% Protein</arm_group_label>
    <arm_group_label>25% Protein</arm_group_label>
    <other_name>macronutrient</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults who were treated for severe childhood malnutrition at the Tropical Metabolism&#xD;
             Research Unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes, hypertension, pregnancy,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>46 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Terrence G Forrester, MBBS, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of the West Indies, Mona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Raubenheimer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aukland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Claudia P Campbell, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of the West Indies, Mona</affiliation>
  </overall_official>
  <reference>
    <citation>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.</citation>
    <PMID>20600416</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22558267</PMID>
  </reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>October 3, 2014</last_update_submitted>
  <last_update_submitted_qc>October 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of The West Indies</investigator_affiliation>
    <investigator_full_name>Claudia Campbell</investigator_full_name>
    <investigator_title>Dr. Claudia Patricia Campbell</investigator_title>
  </responsible_party>
  <keyword>macronutrient</keyword>
  <keyword>malnutrition</keyword>
  <keyword>birth weight</keyword>
  <keyword>protein leverage</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02257593
org study id: ECP 71, 2008/2009
nct id: NCT02257593
lead sponsor: 
collaborator: 
has dmc: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Energy intake (Protein leverage)
time frame: 5 days
description: Total energy intake when placed on 10, 15 or 25% protein energy diet
measure: Weight change
time frame: 5 days
description: over 5 days of consuming diets containing either 10, 15 or 25% protein energy
measure: Protein intake (protein target)
time frame: 3 days
description: protein intake when participants ate freely from menus comprising a combination of foods containing 10, 15 and 25% protein energy
arm group label: 10 % Protein
arm group type: Experimental
description: 10% Dietary protein energy
arm group label: 15% Protein
arm group type: Experimental
description: 15% Dietary protein energy
arm group label: 25% Protein
arm group type: Experimental
description: 25% Dietary protein energy
intervention type: Other
intervention name: Dietary protein
description: 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
arm group label: 10 % Protein
arm group label: 15% Protein
arm group label: 25% Protein
other name: macronutrient
criteria: 
gender: All
minimum age: 17 Years
maximum age: 46 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Terrence G Forrester, MBBS, PhD
role: Study Director
affiliation: University of the West Indies, Mona
last name: David Raubenheimer, PhD
role: Principal Investigator
affiliation: University of Aukland
last name: Claudia P Campbell, PhD
role: Principal Investigator
affiliation: University of the West Indies, Mona
citation: 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: 20600416
citation: 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: 22558267
responsible party type: Principal Investigator
investigator affiliation: The University of The West Indies
investigator full name: Claudia Campbell
investigator title: Dr. Claudia Patricia Campbell