Lymphatic Filariasis
Conditions
Interventions
This is a randomized, double-blind, controlled, three-arm clinical trial. Convenience sampling was used. A total of 38 people who met the eligibility criteria were randomly allocated, via lottery, to
Sponsors
Universidade Federal de Pernambuco
Instituto Aggeu Magalhães - Fiocruz Pernambuco
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patients registered at the National Reference Service for Filariasis (Fiocruz-PE); residents in an endemic area for lymphatic filariasis; of both genders; aged between 18 and 85 years old, who had lymphedema of the lower limbs
Exclusion criteria
Exclusion criteria: Patients with edema or lymphedema due to liver diseases, neoplasms, congenital lymphatic alterations, cardiac and/or vascular insufficiencies, who, after medical screening, have no indication for follow-up at the Serviço de Referência Nacional em Filarioses (Fiocruz Pernambuco); patients who were already undergoing nutritional monitoring outside Fiocruz Pernambuco, or who had neurological and/or psychiatric diseases that could make it difficult to understand dietary guidelines; pregnant and/or lactating patients; patients who reported rejections, intolerances or allergies to the use of medium chain triglyceride oil as well as coconut oil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: To evaluate the effect of using source oils of medium-chain fatty acids (extra virgin coconut oil and medium-chain triglyceride oil - TCM oil) on the evolution of lymphedema, verified by perimetry of the affected limb, of lower limbs of resident patients in endemic areas for lymphatic filariasis;Outcome found 1: Extra virgin coconut oil was effective in the involution of lymphedema in the study patients. Monitoring the perimetry of the affected limb (over the 70 days of intervention) showed a reduction in measurements that measure the magnitude of lymphedema at different points (foot, leg, knee and thigh). TCM oil did not promote a significant reduction in lymphedema | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: Evaluate the effect of the intervention on the participants' nutritional status and adiposity, using anthropometric parameters (weight, body mass index (BMI), waist circumference, waist-to-height ratio and hip circumference) and body composition (water, mass lean, fat percentage, body fat index (FMI) and android to gynoid fat ratio);Outcome found 2: In participants who received extra virgin coconut oil: there was a reduction in BMI, waist circumference, waist-to-height ratio, hip circumference, body fat percentage and body fat index. In addition, there was an increase in the percentage of fat-free mass. In participants who received TCM oil: there was a reduction in body weight, BMI values, waist circumference, waist-to-height ratio, hip circumference and body fat percentage. In addition, there was an increase in the percentage of fat-free mass;Expected outcome 3: Evaluate the effect of supplementation on the biochemical parameters of metabolism and inflammation in the evaluated patients, using the following dosages: complete blood count, fasting blood glucose, total cholesterol and fractions, triglycerides, albumin, total proteins, ferritin, vitamin B12, vitamin D, protein C-reactive, TNF alpha, IL-2, IL-4, IL-6, IL-10 and IL-17;Outcome found 3: No unfavorable changes in lipoproteins associated with atherogenesis and increased cardiometabolic risk were identified in any study group. On the contrary, TCM oil led to a reduction in VLDL and TG levels. And, the modulation exerted on inflammatory markers was due to the elevation of IL-2 and IL-4 levels in patients who received TCM oil. There was a probable trend towards the reduction of pro-inflammatory markers such as TNF-alpha and CRP in all groups;Expected outcome 4: Evaluate the influence of the intervention on the participants' perception of quality of life, using the abbreviated instrument for assessing quality of life - WHOQOL-bref, developed by the World Health Organization. The WHOQOL-bref co | — |
Countries
Brazil
Contacts
Public ContactJacqueline da Silva
Universidade Federal de Pernambuco
Outcome results
None listed