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The impact of an oral nutritional supplement on body weight gain in older adults with malnutrition: an open-label randomized controlled trial.
Jayawardena, R, Wickramawardhane, P, Dalpatadu, C, Hills, AP, Ranasinghe, P
Trials. 2023;(1):625
Abstract
BACKGROUND The global aging population is expanding rapidly and many individuals have a particularly higher risk of malnutrition. Malnutrition can lead to impaired body function, morbidity, and mortality. Meeting nutritional requirements is a key strategy to minimize multiple debilitating adverse outcomes associated with malnutrition in the elderly. Oral nutritional supplements (ONS) have been widely used as a dietary intervention for malnutrition in older adults. These supplements provide additional nutrients and calories to support nutritional requirements and have been shown to improve nutritional status, physical function, and quality of life in malnourished older adults. METHODS This is an open-label, randomized controlled, parallel-group study including 50 institutionalized older adults (aged > 60 years) with malnutrition or at risk of malnutrition, living in a selected elderly care institution in Colombo, Sri Lanka. The aim is to assess improvement in healthy body weight gain and body composition in older adults with malnutrition at risk of malnutrition by using an ONS. Older adults will be screened for malnutrition using the Mini Nutrition Assessment (MNA) tool and eligible participants randomized using the simple random sampling technique to intervention and control groups (1:1 allocation ratio). The intervention group will consume 200 mL of ONS before bed continuously for 12 weeks. The primary outcome is the percentage who achieved at least 5% weight gain in the intervention group compared to the control group. Nutritional status (anthropometric, biochemical, clinical, and dietary), body composition (dual-energy X-ray absorptiometry), frailty, functional capacity (hand grip strength, knee extension, and Barthel index) cognitive status (Montreal Cognitive Assessment), and physical activity will be assessed as secondary outcomes at baseline and at the end of the 12-week intervention. Some measurements (anthropometry, dietary, and functional assessments) will also be performed at the end of the 4th week. Data will be analyzed using SPSS V-23. DISCUSSION This study will determine whether the use of an ONS is effective in promoting healthy weight gain in older adults with malnutrition or at risk of malnutrition. In addition, investigating the impact of an ONS on multiple outcomes via clinical, nutritional, functional, and cognitive function will provide a more comprehensive understanding of the potential benefits of these supplements. TRIAL REGISTRATION Sri Lanka Clinical Trail Registry SLCTR/2022/021. Oct. 6, 2022.
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Coconut oil consumption and bodyweight reduction: a systematic review and meta-analysis.
Swarnamali, H, Ranasinghe, P, Hills, AP, Jayawardena, R
Minerva endocrinology. 2023;(1):76-87
Abstract
INTRODUCTION Due to the composition and biological properties of coconut oil, there is still considerable debate regarding potential benefits for the management of obesity, including the specific impact on body weight (BW) reduction. This systematic review and meta-analysis of clinical trials aims to assess the impact of coconut oil on BW reduction in comparison to other oils and fats. EVIDENCE ACQUISITION The databases, PubMed®, Web of Science®, EMBASE®, and SciVerse Scopus® were systematically searched. A combination of medical subject headings and words linked to coconut oil and obesity parameters were utilized. Any clinical trials comparing coconut oil to any other form of oil or fat, with more than one month feeding period among adults were considered. EVIDENCE SYNTHESIS From the 540 potentially relevant papers, 9 were included. The period of coconut oil intake varied from four to twelve weeks, apart from one long-term trial where coconut oil was consumed for two years. When compared to other oils and fats, coconut oil substantially decreased BW (N.=546), Body Mass Index (BMI) (N.=551), and percentage of fat mass (FM%) (N.=491) by 0.75 kg (P=0.04), 0.28 kg/m2 (P=0.03), and 0.35% (P=0.008), respectively. Coconut oil consumption did not result in any significant alteration in waist circumference (WC) (N.=385) (-0.61 cm; P=0.30), waist-to-hip ratio (WHR) (N.=330) (-0.01; P=0.39) and FM (N.=86) (-0.25 kg; P=0.29). CONCLUSIONS Results indicate a small statistically significant reduction in BW, BMI, and FM% in the coconut oil group. In contrast, consumption of coconut oil had no statistically significant effect on WC, WHR, or FM.
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Gestational obesity: An unconventional endocrine disruptor for the fetus.
Barrea, L, Vetrani, C, Verde, L, Frias-Toral, E, Garcia-Velasquez, E, Ranasinghe, P, Mendez, V, Jayawardena, R, Savastano, S, Colao, A, et al
Biochemical pharmacology. 2022;:114974
Abstract
Obesity has reached pandemic proportions and is a growing concern throughout the world. A parallel trend has also been observed among women in reproductive age, leading to the increasing global prevalence of gestational obesity (GO). The well-known obesity-related health problems also extend to pregnancy, where they are responsible for giving rise to a variety of medical and obstetrical complications, resulting in an increased incidence of adverse maternal and fetal outcomes. In this context, several epidemiological and clinical studies have shown that nutritional changes through different stages of gestation can have a substantial impact on the future health and development of the child. Therefore, it is clear that GO is a modifiable endocrine disruptor that negatively influences the health of the fetus and the newborn, with long-term metabolic implications. This review aims to describe the impact of GO on maternal and fetal outcomes using the available scientific literature and highlighting the evidence-based nutritional approaches currently recommended for the management of GO.
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Prognostic and Therapeutic Role of Vitamin D in COVID-19: Systematic Review and Meta-analysis.
Dissanayake, HA, de Silva, NL, Sumanatilleke, M, de Silva, SDN, Gamage, KKK, Dematapitiya, C, Kuruppu, DC, Ranasinghe, P, Pathmanathan, S, Katulanda, P
The Journal of clinical endocrinology and metabolism. 2022;107(5):1484-1502
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Vitamin D is implicated in optimum function of the immune system. Its deficiency has been linked to susceptibility to respiratory infections. It is postulated that vitamin D deficiency/insufficiency is also associated with COVID-19. The aim of this study was to determine the association between vitamin D deficiency/insufficiency and susceptibility to COVID-19, its severity, mortality and role of vitamin D in its treatment. This study is a systematic review and meta-analysis of seventy-six publications. Results show increased odds of developing COVID-19, progression to severe COVID-19 and death in people with vitamin D deficiency/insufficiency. In fact, people who developed COVID-19, severe COVID-19 and fatal disease had lower 25-hydroxy vitamin D concentration compared to people without COVID-19 or non-severe COVID-19 or non-fatal COVID-19 respectively. Authors conclude that Vitamin D deficiency/insufficiency may increase the risk of developing COVID-19 infection and susceptibility to more severe disease.
Abstract
PURPOSE Vitamin D deficiency/insufficiency may increase the susceptibility to coronavirus disease 2019 (COVID-19). We aimed to determine the association between vitamin D deficiency/insufficiency and susceptibility to COVID-19, its severity, mortality, and role of vitamin D in its treatment. METHODS We searched CINAHL, Cochrane library, EMBASE, PubMED, Scopus, and Web of Science up to May 30, 2021, for observational studies on association between vitamin D deficiency/insufficiency and susceptibility to COVID-19, severe disease, and death among adults, and, randomized controlled trials (RCTs) comparing vitamin D treatment against standard care or placebo, in improving severity or mortality among adults with COVID-19. Risk of bias was assessed using Newcastle-Ottawa scale for observational studies and AUB-KQ1 Cochrane tool for RCTs. Study-level data were analyzed using RevMan 5.3 and R (v4.1.0). Heterogeneity was determined by I2 and sources were explored through prespecified sensitivity analyses, subgroup analyses, and meta-regressions. RESULTS Of 1877 search results, 76 studies satisfying eligibility criteria were included. Seventy-two observational studies were included in the meta-analysis (n = 1 976 099). Vitamin D deficiency/insufficiency increased the odds of developing COVID-19 (odds ratio [OR] 1.46; 95% CI, 1.28-1.65; P < 0.0001; I2 = 92%), severe disease (OR 1.90; 95% CI, 1.52-2.38; P < 0.0001; I2 = 81%), and death (OR 2.07; 95% CI, 1.28-3.35; P = 0.003; I2 = 73%). The 25-hydroxy vitamin D concentrations were lower in individuals with COVID-19 compared with controls (mean difference [MD] -3.85 ng/mL; 95% CI, -5.44 to -2.26; P ≤ 0.0001), in patients with severe COVID-19 compared with controls with nonsevere COVID-19 (MD -4.84 ng/mL; 95% CI, -7.32 to -2.35; P = 0.0001) and in nonsurvivors compared with survivors (MD -4.80 ng/mL; 95% CI, -7.89 to -1.71; P = 0.002). The association between vitamin D deficiency/insufficiency and death was insignificant when studies with high risk of bias or studies reporting unadjusted effect estimates were excluded. Risk of bias and heterogeneity were high across all analyses. Discrepancies in timing of vitamin D testing, definitions of severe COVID-19, and vitamin D deficiency/insufficiency partly explained the heterogeneity. Four RCTs were widely heterogeneous precluding meta-analysis. CONCLUSION Multiple observational studies involving nearly 2 million adults suggest vitamin D deficiency/insufficiency increases susceptibility to COVID-19 and severe COVID-19, although with a high risk of bias and heterogeneity. Association with mortality was less robust. Heterogeneity in RCTs precluded their meta-analysis.
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Health effects of coconut oil: Summary of evidence from systematic reviews and meta-analysis of interventional studies.
Jayawardena, R, Swarnamali, H, Ranasinghe, P, Misra, A
Diabetes & metabolic syndrome. 2021;(2):549-555
Abstract
BACKGROUND AND AIMS Systemic review (SR) and meta-analysis (MA) of interventional studies are considered as the highest level of evidence for clinical decision making. Therefore, we systematically summarized all high-quality evidence on the usage of coconut oil for health-related benefits from SRs and MA. METHODS PubMed®, Web of science®, SciVerse Scopus®, and EMBASE® databases were systematically searched to select SRs and SRs with MA of interventional studies reporting health-related clinical outcomes of coconut oil. Similar studies were grouped based on their respective clinical areas. A methodological quality appraisal was conducted for all included SRs and SRs with MA using the Critical Appraisal Checklist for Systematic Reviews. RESULTS A total of seven papers were selected for inclusion in this review, consisting of three MA and one SR on cardio-metabolic health, one SR on oral health, and one SR and one MA each on skin health. Coconut oil significantly increases serum total cholesterol, low-density- and high-density- lipoprotein cholesterol levels compared to poly- and mono-unsaturated oils. Limited studies showed that topical use of coconut oil helps in the prevention and treatment of atopic dermatitis and oil pulling for the prevention of dental caries. All four studies on cardiometabolic health and the SR on oral health had a high score in the quality assessment, SR with MA on skin health fulfilled high-quality scoring whereas the SR on the same topic had a low-quality scoring. CONCLUSIONS In summary, consistent and strong evidence shows that coconut oil has an adverse effect on the lipids parameters associated with cardio-metabolic health, with limited studies to conclude the effects of atopic dermatitis and oil pulling.
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Impact of portion-control plates (PCP) on weight reduction: A systematic review and meta-analysis of intervention studies.
Jayawardena, R, Swarnamali, H, Ranasinghe, P, Hills, AP
Obesity research & clinical practice. 2021;(2):106-113
Abstract
BACKGROUND The purpose of this systematic review and meta-analysis was to assess whether the available research to date supports the use of portion-controlled plate (PCP) and leads to reductions in body weight and improvements in other anthropometric and biochemical parameters. The systematic review summarizes existing PCPs and their impact on anthropometric and metabolic changes. METHODS A systematic search was conducted in the following databases: PubMed®, Web of Science®, Scopus®. Data were pooled using random or fixed effects meta-analysis. RESULTS From 426 potentially relevant articles, 5 publications were included in this review, and 4 of which reported four different PCPs. All five studies reported a positive effect of PCP on obesity and metabolic parameters. PCP significantly reduced body weight (BW) by 2.02 kg (95% CI, -3.03 to -1.01, p < 0.0001), body mass index (BMI) by 0.87 kg m-2 (95% CI, -1.28 to -0.47, p < 0.0001) and waist circumference (WC) by 2.28 cm (95% CI, -4.57 to 0.01, p = 0.05). A non-significant reduction was observed for waist-to-hip ratio (WHR) (-0.01, 95% CI, -0.03 to 0.01, p = 0.35) during the three-month intervention period. PCP significantly decreased both BW (-1.66 kg; 95% CI, -2.69 to -0.62, p = 0.002) and percentage body weight (% BW) (-1.64%; 95% CI, -2.69 to -0.58, p = 0.002) when the intervention was undertaken for a 6-month period. CONCLUSIONS Overall, results showed that portion control intervention significantly reduced BW, BMI and WC, along with a positive trend for WHR, plus biochemical and blood pressure reduction.
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The use of Caralluma fimbriata as an appetite suppressant and weight loss supplement: a systematic review and meta-analysis of clinical trials.
Jayawardena, R, Francis, TV, Abhayaratna, S, Ranasinghe, P
BMC complementary medicine and therapies. 2021;(1):279
Abstract
BACKGROUND Obesity prevalence has increased during the past few decades, causing a pandemic with an influx in other co-morbidities. Many factors influence weight gain in an obesogenic environment therefore strategies for treating obesity may vary from conventional dietary and physical activity interventions to pharamacotherapy. A shift in unconventional strategies as herbal products for treating obesity have been investigated and one such plant extract is Caralluma fimbriata (C. fimbriata). Further, the studies included were systematically reviewed to gather evidence on potential effects of C. fimbriata as an appetite suppressant and weight loss supplement. METHODS A systematic review of clinical trials reporting the effects of C. fimbriata as appetite suppression and anti-obesity supplement was reported according to PRISMA guidelines. Data were obtained by searching three databases: PubMed®, Web of Science® and SciVerse Scopus® for studies published until 30th April 2020. RESULTS A total of 7 articles studying C. fimbriata satisfied the inclusion and exclusion criteria and were sourced from various countries including Australia (3), Cuba (1), India (2) and Spain (1). Almost all studies recruited adults who were overweight or obese with a BMI > 25 kg/m2 (n = 5), with the exception of two studies, one that recruited healthy adults with a BMI average of 26.5 kg/m2 and the second one utilised a population of children and adolescents with Prader-Willis Syndrome (PWS). Parameters assessing obesity, biochemical and appetite factors were analysed by carrying out a meta-analysis. Compared to placebo controlled group, C. fimbriata extract significantly reduced WC by 1.59 cm (95% CI, - 3.07 to - 0.10, p = 0.041) and WHR by 0.06 (95% CI, - 0.12 to - 0.01, p = 0.05) although no significant effects were seen on BW, BMI and HC. Biochemical and appetite parameters outcome on C. fimbriata consumption had no significant changes. Any side effects of individuals who ingested the extract were reported by few studies of which most common effects were constipation, diarrhoea, nausea and rashes. CONCLUSION Appetite parameters showed no significant changes and metabolic parameters did not improve with C.fimbriata supplementation therefore it is unlikely to recommend C. fimbriata as a weight loss supplement and an appetite suppressant.
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Enhancing immunity in viral infections, with special emphasis on COVID-19: A review.
Jayawardena, R, Sooriyaarachchi, P, Chourdakis, M, Jeewandara, C, Ranasinghe, P
Diabetes & metabolic syndrome. 2020;14(4):367-382
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A healthy immune system is one of the most important weapons in relation to the current pandemic of COVID-19 where no effective preventive and curative medicine is available. The main aim of this study was to evaluate the evidence on enhancing immunity in viral infections. This review focuses on influenza-like viral infections; however, other studies on viral infections have also been included. It included 43 articles of which 13 were on vitamins, 8 on minerals, 18 on nutraceuticals and 4 on probiotics. Results indicate that: - vitamin supplementation, especially vitamin D may be beneficial in people who are either deficient or insufficient. - adverse effects of vitamin E supplementation on the immune response have been reported. - there are several beneficial nutraceuticals, however their efficacy and safety depend on their ingredients, as well as various other factors including, methods of extraction. - in addition to basic hygienic practices, proper dietary and lifestyle behaviours are essential for prevention and treatment of respiratory viral diseases. Authors conclude that achieving recommended amounts of calories and micronutrient will be a challenge and elective micronutrient supplementations may be beneficial especially for vulnerable populations such as the elderly.
Abstract
BACKGROUND AND AIMS Balanced nutrition which can help in maintaining immunity is essential for prevention and management of viral infections. While data regarding nutrition in coronavirus infection (COVID-19) are not available, in this review, we aimed to evaluate evidence from previous clinical trials that studied nutrition-based interventions for viral diseases (with special emphasis on respiratory infections), and summarise our observations. METHODS A systematic search strategy was employed using keywords to search the literature in 3 key medical databases: PubMed®, Web of Science® and SciVerse Scopus®. Studies were considered eligible if they were controlled trials in humans, measuring immunological parameters, on viral and respiratory infections. Clinical trials on vitamins, minerals, nutraceuticals and probiotics were included. RESULTS A total of 640 records were identified initially and 22 studies were included from other sources. After excluding duplicates and articles that did not meet the inclusion criteria, 43 studies were obtained (vitamins: 13; minerals: 8; nutraceuticals: 18 and probiotics: 4). Among vitamins, A and D showed a potential benefit, especially in deficient populations. Among trace elements, selenium and zinc have also shown favourable immune-modulatory effects in viral respiratory infections. Several nutraceuticals and probiotics may also have some role in enhancing immune functions. Micronutrients may be beneficial in nutritionally depleted elderly population. CONCLUSIONS We summaries possible benefits of some vitamins, trace elements, nutraceuticals and probiotics in viral infections. Nutrition principles based on these data could be useful in possible prevention and management of COVID-19.
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Exploring the Therapeutic Benefits of Pranayama (Yogic Breathing): A Systematic Review.
Jayawardena, R, Ranasinghe, P, Ranawaka, H, Gamage, N, Dissanayake, D, Misra, A
International journal of yoga. 2020;(2):99-110
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BACKGROUND Pranayama (yogic breathing) has demonstrated numerous beneficial health effects. At present, there are no systematic reviews evaluating the beneficial health effects of pranayama alone as a practice. AIM: The aim of this study is to perform a systematic review about the beneficial health effects of pranayama. METHODS Data were obtained using a stepwise search process by searching the online PubMed, Web of Science, and SciVerse Scopus databases using keywords. Controlled clinical trials in humans, using "Pranayama" as an intervention with an appropriate control group and evaluating health-related outcomes were selected for inclusion. RESULTS Initial database searching indicated 669 potentially eligible articles, of which 18 studies satisfying the inclusion/exclusion criteria were selected. All were controlled trials, of which 13 were randomized and 1 was a crossover study. Number of participants ranged from 16 to 160, and the duration of pranayama practice varied from 4 days to 6 months. Studies demonstrated a significant effect on cardiorespiratory functions, in patients with bronchial asthma, with the improvement of pulse rate, systolic blood pressure, and respiratory function measurements. Furthermore, reduction in the frequency of attacks, severity, and medication requirement was also observed, with improved quality of life (QOL). In patients with chronic obstructive pulmonary disease, symptom, activity, and impact scores were improved. QOL improvement was also noted in cancer patients. CONCLUSIONS Available evidence on pranayama indicates physiological and psychological benefits. Beneficial effects were mostly observed in patients with respiratory diseases such as bronchial asthma. It also helped those with cancer and cardiovascular disease. However, further high-quality randomized trials are required to provide definitive evidence.
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Effects of the Lysulin™ supplementation on pre-diabetes: A randomized double-blind, placebo-controlled clinical trial.
Ranasinghe, P, Jayawardena, R, Chandrasena, L
Diabetes & metabolic syndrome. 2020;(5):1479-1486
Abstract
BACKGROUND AND AIMS Diabetes is a leading cause of morbidity and mortality worldwide. Recent studies have demonstrated that nutraceutical products have beneficial effects in diabetes. Present study aims to investigate whether a product (Lysulin™) containing amino acid lysine, micronutrient zinc and vitamin C will have beneficial effects in pre-diabetes. METHODS A randomized, double-blind, placebo-controlled trial was conducted for a period of 6 months. The two parallel groups (1:1) were Lysulin™ (Interventional group-IG) and placebo (control group-CG). Evaluations were done at baseline, 1, 3 and 6 months. Primary outcome was defined as change in glycaemic control measured by HbA1c from baseline. Other outcomes included change in; fasting plasma glucose (FPG), 2-h OGTT plasma glucose and lipid profile from baseline. Three multiple regression analyses were performed, where change in FPG, 2-h OGTT, and HbA1c post intervention from baseline respectively were the continuous dependent variable with other independent variables. RESULTS One hundred and ten participants were recruited, 50% (n = 55) were males and mean age (±SD) was 46.7 ± 9.9 years. A significantly higher percentage of participants in CG (25.4%, n = 14) developed diabetes in comparison to IG (7.3%, n = 4) (p = 0.018). FPG, 2-h OGTT and HbA1c significantly reduced in the IG only. Both total cholesterol and LDL cholesterol decreased significantly from baseline only in the IG. In all three regression models the best predictor of respective dependent variable was Lysulin™ treatment. CONCLUSIONS Lysulin™ improved glycaemic control, with reduced progression to diabetes, in those with pre-diabetes. Treatment also showed a beneficial reduction in total and LDL cholesterol levels. TRIAL REGISTRATION Sri Lanka Clinical Trials Registry, identifier: SLCTR/2018/022 (http://slctr.lk/trials/1290). Registered on 13th July 2018; Study protocol version 2.0 (23rd March 2018).