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Intervening to Repair Cognitive and Behavioural Problems in Adults Exposed to Childhood Malnutrition

Sponsored by The University of The West Indies

About this trial

Last updated 6 years ago

Study ID

ECP235,15/16

Status

Unknown status

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
20 to 55 Years
All
All

Trial Timing

Ended 5 years ago

What is this trial about?

Globally, in 2011, 52 million children under 5 years old suffered from acute malnutrition, and a further 165 million children showed evidence of chronic undernutrition or stunting. It was also estimated that 3.1 million children died in 2011 of malnutrition related causes. The survivors, due to deprivation of critical nutrients in the most important period of development and growth, are left with permanent damage, including an increased risk of cardio-metabolic disease, poorer educational achievement and diminished earning potential. In Jamaica in 2012, 2.5% of children were moderately or severely underweight (more than two standard deviations below weight-for-age by international reference populations), falling from as high as 8.9% in 1993. Though there have been modest reductions in the incidence of acute malnutrition in Jamaica over the past 20 years, the risk remains high in poor families and among children who are being weaned. Hence, the problem is an ongoing one and we have a significant pool of survivors of childhood malnutrition who have now reached adulthood and face the consequences of early nutrient deprivation. The brain is particularly vulnerable to the effects of malnutrition and studies have demonstrated both structural (brain atrophy) and functional (cognitive impairment and poor academic achievement) changes. This evidence, however, has been mainly in later childhood and adolescence. In addition, there is local data that suggests that cardio-metabolic risk factors are increased in these adult survivors, which are well-described precursors of cerebrovascular disease and cognitive impairment. Therefore, in adulthood there may be accelerated cognitive decline due to a poor cardio-metabolic profile superimposed on pre-existing brain injury. We hypothesise that there are differences in cognitive function (poorer memory and executive function)and emotional responses in adult survivors of childhood malnutrition compared to those not exposed to early childhood malnutrition. There is evidence suggesting that aerobic exercise and omega-3 supplementation have some benefit in reversing cognitive decline in older adults, but they have not been investigated in survivors of childhood malnutrition.Hence, we propose to introduce a six month intervention of supervised aerobic exercise and omega-3 supplementation, and will compare cognitive function pre and post intervention/placebo between malnutrition survivors and controls.

What are the participation requirements?

Yes

Inclusion Criteria

- SAM survivors, both males and females and between the ages of 20 and 50 years

- Community controls will be identified from the same street address as the cases and matched for sex, age ±5 years.

No

Exclusion Criteria

- Pregnancy

- Unstable angina or myocardial infarction diagnosed within 3 months;

- Heart failure (New York Heart Association category 2) or significant valvular dysfunction;

- Peripheral arterial disease with claudication, major orthopaedic, chronic pain, or neuromuscular disorders restricting exercise;

- Pulmonary or renal failure;

- Poorly controlled hypertension (>190/110 mmHg) on two separate occasions, or type 2 diabetes mellitus, or type 1 diabetes mellitus regardless of control;

- Recent hospitalisation for severe disease or surgery;

- Regularly exercises at moderate or vigorous intensity for more than 30 minutes three times or more per week;

- Is currently taking daily omega-3 supplements for over two weeks.