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ObesityNCT02257593

Developmental Adaptation to an Obesogenic Environment

A study testing Dietary protein in people with Obesity, run by The University of The West Indies.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 17 to 46 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Dietary protein
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
No sites listed yet
Study dates
May 2009to Jun 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 46 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • Diabetes, hypertension, pregnancy,

About this study

Official title: 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).

Read the 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.

Conditions
Obesity
Being tested
Dietary protein
Keywords
macronutrient, malnutrition, birth weight, protein leverage
Medical subject headings
Obesity, Malnutrition, Birth Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary proteinOther

    Also called macronutrient

    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

Study groups in NCT02257593
Study groupRoleWhat they receive
10 % ProteinExperimental10% Dietary protein energy
Receives: Other: Dietary protein
15% ProteinExperimental15% Dietary protein energy
Receives: Other: Dietary protein
25% ProteinExperimental25% Dietary protein energy
Receives: Other: Dietary protein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Energy intake (Protein leverage)

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

    Measured: 5 days

Secondary outcomes (1)
  1. Weight change

    over 5 days of consuming diets containing either 10, 15 or 25% protein energy

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2014 (estimated)
  2. Study startMay 2009
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02257593
Sponsor's protocol ID
ECP 71, 2008/2009
Status last verified
Oct 2014
First submitted
1 Oct 2014
Last updated
6 Oct 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20600416
  • 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.

    PubMed 22558267

Questions about this trial

What is this clinical trial studying?

A study testing Dietary protein in people with Obesity, run by The University of The West Indies.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Energy intake (Protein leverage) (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02257593, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2014.

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Developmental Adaptation to an Obesogenic Environment | AzTrials