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

NCT04053218 | Unknown Phase 3

• 1 other identifier: ECP235,15/16
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Acute Malnutrition; Cognitive Impairment; Emotional Disturbances

Keywords

Adult survivors of severe acute malnutrition; Cognition

Outcome Measures

Primary Outcomes (1)

• Cognition

  NIH Toolbox Computerized Cognitive Battery

  Six months

Secondary Outcomes (1)

• Emotional disturbances

  Six months

Other Outcomes (4)

• Glucose impairment

  Six months

• Lipid metabolism

  Six months

• Body fat changes

  Six months

Study Arms (2)

Exercise and supplement

ACTIVE COMPARATOR

Supervised aerobic exercise three times weekly and daily omega-3 supplements

Combination Product: Exercise plus omega-3 supplement

Placebo

PLACEBO COMPARATOR

Olive oil capsules. No supervised exercise but written recommendations for daily physical activity from the American Heart Association

Dietary Supplement: Placebo

Interventions

Exercise plus omega-3 supplement COMBINATION_PRODUCT

Supervised aerobic exercise and omega-3 supplement

Exercise and supplement

Placebo DIETARY_SUPPLEMENT

Olive oil placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

University of the West Indies

Kingston, Jamaica

RECRUITING

Related Publications (4)

• Francis-Emmanuel PM, Thompson DS, Barnett AT, Osmond C, Byrne CD, Hanson MA, Gluckman PD, Forrester TE, Boyne MS. Glucose metabolism in adult survivors of severe acute malnutrition. J Clin Endocrinol Metab. 2014 Jun;99(6):2233-40. doi: 10.1210/jc.2013-3511. Epub 2014 Feb 11.

  PMID: 24517147 BACKGROUND

• Tennant IA, Barnett AT, Thompson DS, Kips J, Boyne MS, Chung EE, Chung AP, Osmond C, Hanson MA, Gluckman PD, Segers P, Cruickshank JK, Forrester TE. Impaired cardiovascular structure and function in adult survivors of severe acute malnutrition. Hypertension. 2014 Sep;64(3):664-71. doi: 10.1161/HYPERTENSIONAHA.114.03230. Epub 2014 Jun 30.

  PMID: 24980666 BACKGROUND

• Angevaren M, Aufdemkampe G, Verhaar HJ, Aleman A, Vanhees L. Physical activity and enhanced fitness to improve cognitive function in older people without known cognitive impairment. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005381. doi: 10.1002/14651858.CD005381.pub3.

  PMID: 18646126 BACKGROUND

• Dangour AD, Allen E, Elbourne D, Fletcher A, Richards M, Uauy R. Fish consumption and cognitive function among older people in the UK: baseline data from the OPAL study. J Nutr Health Aging. 2009 Mar;13(3):198-202. doi: 10.1007/s12603-009-0057-2.

  PMID: 19262951 BACKGROUND

MeSH Terms

Conditions

Severe Acute Malnutrition; Cognitive Dysfunction; Affective Symptoms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Terrence E Forrester, DM, PhD

  University of the West Indies, Mona Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dean, Faculty of Medicine

CONTACT

876-927-1289; medsci@uwimona.edu.jm

Terrence E Forrester, DM, PhD

CONTACT

876-977-6803; terrence.forrester@uwimona.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will be unaware of whether the capsules are supplement or placebo. The investigators will know that all persons in the exercise group will receive omega-3 supplements and that those not exercising will be receiving placebo capsules.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be enrolled in one of two groups, exercise and omega-3 supplementation or placebo group. Subjects and controls in the first group will receive supervised aerobic exercise on a treadmill, targeting 75-85% heart rate reserve for 45 minutes per session, three days per week. Each participant's heart rate reserve will be calculated using the formula: Heart rate reserve=maximal heart rate - resting heart rate. Each participant in this group will also receive an omega-3 supplement containing 2 grams /day. The placebo group will receive 2 grams of olive oil (mainly oleic acid, a monounsaturated fatty acid) and standardised health education, face-to-face and written (American Heart Association educational materials), including recommendations for regular physical activity and nutrition.

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 12, 2019
• Study Start: January 15, 2018
• Primary Completion: September 7, 2020
• Study Completion: December 14, 2020
• Last Updated: August 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

JA (1)