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Efficacy and Safety of MED-01 Probiotics on Vaginal Health: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Park, SH, Lee, ES, Park, ST, Jeong, SY, Yun, Y, Kim, Y, Jeong, Y, Kang, CH, Choi, HJ
Nutrients. 2023;15(2)
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Bacterial vaginosis (BV) is characterised by the depletion of lactic acid bacteria and overgrowth of certain anaerobic and facultative bacteria leading to an imbalance in the vagina. The high recurrence rate of BV results in repeated exposure to antibiotics and the emergence of drug-resistant bacteria. The aim of this study to evaluate the efficacy of MED-01 [a complex that includes five probiotic strains] on vaginal health and safety This study was a 12-week, randomised, multicentre, double-blind, placebo-controlled clinical trial with two parallel groups receiving either MED-01 or placebo capsules. Results showed that MED-01 intake significantly reduces the Nugent score, a discriminant index of BV, and alleviates symptoms which may appear in BV without any adverse events. Additionally, MED-01 increased the proportion of beneficial Lactobacilli and diminished the harmful BV-causing pathogens. However, there was no significant change in vaginal microbiota. Authors conclude that their findings suggest the possibility of using MED-01 as a new and safe functional probiotic for women with symptoms of BV.
Abstract
Bacterial vaginosis (BV) is the most common disease in women of childbearing age and is caused by the growth of abnormal microbiota in the vagina. Probiotic consumption can be an effective alternative treatment to preserve or improve vaginal health. In the present study, MED-01, a complex of five strains of probiotic candidates isolated from the vagina of Korean women, was used. This study was designed as a 12-week, randomized, multicenter, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of MED-01 on vaginal health. A total of 101 reproductive-aged women with a Nugent score of 4-6 took MED-01 (5.0 × 109 CFU) or a placebo once a day, and 76 participants completed the procedure. MED-01 significantly reduced the Nugent score compared with the placebo. Quantitative PCR analysis confirmed that Lactobacillus plantarum was significantly increased in the vagina, whereas harmful bacteria such as Mobiluncus spp., Gardnerella vaginalis, and Atopobium vaginae were suppressed after 12 weeks of MED-01 ingestion. No adverse events to the test food supplements were observed in the participants. These results confirmed that MED-01 can be used as a probiotic for treating BV, as it improves the vaginal microbiota.
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Consumption of a Beverage Containing Aspartame and Acesulfame K for Two Weeks Does Not Adversely Influence Glucose Metabolism in Adult Males and Females: A Randomized Crossover Study.
Kim, Y, Keogh, JB, Clifton, PM
International journal of environmental research and public health. 2020;17(23)
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Artificial sweeteners gained popularity in the past decade, especially in the food industry. Up until recently, people generally considered it a better option to decrease sugar consumption and reduce obesity and Type 2 Diabetes. This randomised crossover study looked at the adverse effects of two commonly used artificial sweeteners on normal-weight subjects, overweight and obese subjects. A total of 39 healthy subjects without Type 2 Diabetes participated in this study. For two weeks, participants consumed 0.6 litres of a commercially branded soft drink containing acesulfame K and aspartame to assess the effects of the ingredients on glucose homeostasis. During the two-week treatment period, the healthy subjects did not show any significant detrimental impact of artificially sweetened beverages on glucose, insulin and insulin sensitivity. However, the study population was small, and the study was conducted only for a relatively short period. Therefore, further, longer-term robust studies are required to estimate the significance of the detrimental effect of artificially sweetened beverages on glucose homeostasis. Nevertheless, this study can help healthcare practitioners understand the short-term impact of artificial sweeteners, keeping in mind that further research is needed to investigate the effects.
Abstract
There is an association between the consumption of artificial sweeteners and Type 2 diabetes in cohort studies, but intervention studies do not show a clear elevation of blood glucose after the use of artificial sweeteners. The objective of this study was to examine whether two commonly used artificial sweeteners had an adverse effect on glucose control in normal-weight subjects, and in overweight and obese subjects when consumed for 2 weeks. In the study, 39 healthy subjects (body-mass index, kg/m2) (18-45) without Type 2 diabetes with an age of 18-75 years were randomly assigned to 0.6 L/day of an artificially sweetened soft drink containing acesulfame K (950) and aspartame (951) or 0.6 L/day of mineral water for 2 weeks each in a crossover study. There was a 4 week washout period with no drinks consumed. Glucose levels were read by a continuous glucose monitor (CGM) during each 2 week period. A 75 g oral glucose-tolerance test (OGTT) was performed at the beginning and end of each intervention period. Blood samples were collected at baseline, and 1 and 2 h for glucose and insulin. A 2 week intake of artificially sweetened beverage (ASB) did not alter concentrations of fasting glucose and fasting insulin, the area under the curve (AUC) for OGTT glucose and insulin, the incremental area under the curve (iAUC) for OGTT glucose and insulin, the homeostatic model assessment for insulin resistance (HOMA-IR), and the Matsuda index compared with the baseline and with the changes after a 2 week intake of mineral water. Continuous 2 week glucose concentrations were not significantly different after a 2 week intake of ASB compared with a 2 week intake of mineral water. This study found no harmful effect of the artificially sweetened soft drink containing acesulfame K (950) and aspartame (951) on glucose control when consumed for 2 weeks by people without Type 2 diabetes.
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Role of Calcium and Low-Fat Dairy Foods in Weight-Loss Outcomes Revisited: Results from the Randomized Trial of Effects on Bone and Body Composition in Overweight/Obese Postmenopausal Women.
Ilich, JZ, Kelly, OJ, Liu, PY, Shin, H, Kim, Y, Chi, Y, Wickrama, KKAS, Colic-Baric, I
Nutrients. 2019;11(5)
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A woman’s menopausal years are believed to bring about weight gain due to various biological mechanisms, such as depletion of oestrogen. Many women undertake weight loss diets, in an attempt to control the weight gain, and although weight loss can reduce the risk factors for metabolic and cardiovascular disease etc, it can also lead to accelerated loss bone density and muscle mass. The objective of this study was to investigate whether by complementing a low-calorie diet with 4 to 5 servings of low-fat dairy foods per day and/or supplementing with calcium and vitamin D supplements would aid weight loss and preserve either/both bone and muscle mass. The study was conducted on 189 early postmenopausal, obese women. It was a randomized, placebo-controlled clinical trial conducted over 6 months. Researchers found that results were better for the participants on the low-fat dairy foods and those supplementing with calcium and vitamin D when compared to the placebo group (who only had placebo pills). They suggest that when embarking on a weight loss program it is beneficial to include 4 to 5 servings of low-fat dairy foods each day and take calcium and vitamin D supplements will have a positive impact on weight loss, bone density and muscle mass in post-menopausal women.
Abstract
Several studies have investigated the possibility of dairy foods and calcium (Ca) mediating weight and body composition, but a consensus has not been reached. We aimed to investigate weight-loss-related outcomes during intervention with low-fat dairy foods or Ca + vitamin D supplements, both as complements to hypocaloric diets. Overweight/obese Caucasian, early-postmenopausal women (n = 135) were recruited for a 6 month energy-restricted weight loss study complemented with either low-fat dairy foods (D; 4-5 servings/day), or Ca + vitamin D supplements (S); both to amount a total of ~1500 mg/day and 600 IU/day of Ca and vitamin D, respectively, or placebo pills (C). Bone mineral density (BMD) and lean and fat tissue were measured by Lunar iDXA. Serum and urinary markers of bone turnover were analyzed. Diet and physical activity were assessed with 3-day records. Participants on average lost ~4%, ~3%, and ~2% of body weight, fat, and lean tissue, respectively. The significantly better outcomes were noticed in participants in the D group regarding body composition (fat loss/lean tissue preservation) and in participants in the S group regarding the BMD outcomes, compared to those in the C group. Therefore, increasing low-fat dairy foods to 4-5 servings/day and/or increasing Ca & vitamin D intake by supplements (in those who are at the borderline dietary intake) may be beneficial for weight loss/maintenance and may lead to more favorable bone and body composition outcomes in postmenopausal women during moderate weight loss.
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The Effect of a Multidisciplinary Lifestyle Intervention on Obesity Status, Body Composition, Physical Fitness, and Cardiometabolic Risk Markers in Children and Adolescents with Obesity.
Seo, YG, Lim, H, Kim, Y, Ju, YS, Lee, HJ, Jang, HB, Park, SI, Park, KH
Nutrients. 2019;11(1)
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Children and adolescents with obesity are at a high risk of being obese in adulthood. The aim of this study was to develop a multidisciplinary lifestyle intervention program targeted at children and adolescents with moderate to severe obesity. The study is based on the Intervention for Childhood and Adolescents Obesity via Activity and Nutrition (ICAAN) – quasi-experimental intervention trial - which recruited 103 participants aged between 6 and sixteen years (63 were boys and 40 girls). The study was based on 2 active treatment groups (usual care group vs exercise group) receiving a 16-week intervention program. Results indicate that children and adolescents with obesity can achieve positive effects on body composition, physical fitness, and cardiometabolic markers, particularly with the exercise intervention. Authors conclude that the moderate-intensity multidisciplinary lifestyle intervention program they developed, can be sustained in the real-world setting and it is applicable to both moderate and severe obesity.
Abstract
This study aimed to develop a multidisciplinary lifestyle intervention program targeted at children and adolescents with moderate to severe obesity, and assess the additional effects of exercise intervention when compared to usual care. Overall, the 103 enrolled participants were ≥85th percentile of age and sex-specific body mass index (BMI). Participants were divided into groups that received 16 weeks of either usual care or exercise intervention. The BMI z-score of the overall completers decreased by about 0.05 after the 16-week intervention (p = 0.02). After the intervention, only the exercise group had a significantly lower BMI z-score than the baseline score by about 0.1 (p = 0.03), but no significant group by time interaction effects were observed. At the 16-week follow-up, significant group by time interaction effects were observed in percentage body fat (%BF) (β = -1.52, 95%CI = -2.58⁻-0.45), lean body mass (LM) (β = 1.20, 95%CI = 0.12⁻2.29), diastolic blood pressure (β = -5.24, 95%CI = -9.66⁻-0.83), high-sensitivity C-reactive protein (β = -1.67, 95%CI = -2.77⁻-1.01), and wall sit test score (β = 50.74, 95%CI = 32.30⁻69.18). We developed a moderate-intensity intervention program that can be sustained in the real-world setting and is practically applicable to both moderate and severe obesity. After interventions, the exercise group had lower %BF and cardiometabolic risk markers, and higher LM and leg muscle strength compared to the usual care group.