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Human milk is the only source of iodine during early infancy and adequate iodine intake during lactation is necessary to assure optimal thyroid function in breastfed infants. However, the physiological requirement of iodine in lactating women is uncertain and recommendations for the daily dietary average requirement are poorly defined. WHO recommends iodine supplementation to lactating women in populations with incomplete coverage of iodized salt and deficient iodine intake, but the scientific evidence is weak and the optimal dose is uncertain. The primary objective is to assess the daily dietary average requirement for iodine in lactating women. Secondary objectives are to: - Estimate the daily average requirement for iodine in exclusively breastfed infants; - Assess the dose-response of dietary iodine supplements on breast milk iodine concentration in lactating women with adequate and inadequate habitual iodine intakes; - Estimate the maternal iodine intake required to provide exclusively breastfed infants with an adequate iodine intake via breast milk.
The main purpose of this study is to evaluate the safety and tolerability of LY3541105 in healthy and overweight participants. Blood tests will be performed to check how much LY3541105 gets into the bloodstream and how long it takes the body to eliminate it. The study will also evaluate the effects of LY3541105 on body weight. This is a 2-part study and may last up to 15 and 26 weeks for each participant and may include up to 7 and 15 visits in parts A and B, respectively.
Astaxanthin is recognized as a bioactive compound with potential benefits for human health. This study aims to evaluate a specific nutritional supplement impact on markers of oxidative stress, inflammation, lipid levels, blood flow, visual skin markers, measures of longevity, mood and skin condition.
The support for siblings of children with disabilities is scarce and fragmented, even though studies have shown that these siblings can benefit from support. Although some interventions for siblings have been developed, these are costly and time-consuming and the effects have not been researched thoroughly with randomized controlled trials. This study will investigate the effectiveness of the newly developed serious game 'Broodles' in improving the quality of life and psychosocial well-being of healthy siblings (aged 6-9 years) of children with intellectual disability (ID) and/or visual impairment (VI). The effectiveness of the serious game will be examined in a randomized controlled trial (RCT) with a pre-test (T0), post-test (T1) and follow-up (T2). There will be two groups, namely an experimental group playing the serious game and a waitlist control group. Quantitative and qualitative measures will be used including questionnaires, drawings and open-ended questions. Both the sibling and one parent will complete the assessments. The serious game, named 'Broodles', is a psychological intervention that addresses how to handle thoughts and emotions concerning several important issues in the lives of siblings. The game has 8 levels that take approximately 20 minutes to play. In addition to the serious game, children make offline worksheets and parents receive tips and information on how to support their child. The primary study parameters are quality of life and sibling adjustment to and perceptions of the disability of the brother or sister. Secondary study parameters are different aspects of psychosocial well-being, including self-esteem, experienced social support, sibling relationship, coping skills, parent-child relationship, and social validity. It is expected that the participants in the experimental conditions will benefit from playing the game, namely their quality of life and psychosocial well-being is expected to improve.
This is a randomised, double-blind, double-dummy, active-controlled, three-period crossover euglycemic clamp trial in healthy Chinese volunteers. Each subject will be randomly allocated to one of 6 treatment sequences. Each sequence comprises one single dose of BC Combo THDB0207, one single dose of Humalog® Mix25, or simultaneous administration of Humalog® and Lantus®. Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.
The project aims to evaluate the glycaemic index of breads from different types of flour. In particular, we aim to understand the glycaemic and insulin responses as well as satiety and sensory profiles of the products.
The use of probiotics is a widespread clinical practice to improve the composition of the microbiota in healthy and pathological patients. However, in recent years, inactivated microorganisms have begun to be used that can exert a certain anti-inflammatory effect at the intestinal level. Among them, Bifidobacterium longum (CECT 7347) has been used in various clinical trials with promising results. It has immunoregulatory properties and an excellent ability to attenuate the activity of epithelial cells at the intestinal level. However, it is necessary to carry out clinical trials to verify its effects, preferably in healthy patients who show certain gastrointestinal discomfort. For this reason, a parallel, randomized, double-blind, controlled pilot clinical trial with 2 study arms has been proposed to assess the effect of habitual consumption of B. longum CECT 7347 on mild-moderate functional digestive disorders in a group of healthy people.
This study is being done to measure real-world motions and forces in the spine during everyday activities. This information will be used to develop and validate a computer model of how the spine moves and determine injury risk.
This single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on pain thresholds.
Physical activity triggers complex molecular responses, including changes in immune-, stress-, and metabolic pathways. For example, autophagy is essential for energy and cellular homeostasis through protein catabolism, and dysregulation results in compromised proteostasis, reduced exercise performance, and excessive secretion of signaling molecules and inflammatory proteins. However, previous research has been limited by the extend of molecules measured and biological processes covered. A better understanding of these processes through multi-omic analysis can improve knowledge of molecular changes in response to exercise. The main purpose of the investigators study is to analyze the effects of acute exercise in correlation to autophagy and other signaling cascades. Specifically, the investigators plan to perform multi-level molecular profiling in a cohort of healthy male elite cyclists and male and female recreational athletes, before, during, and after a bicycle ergometer test. The results will be compared to a control cohort without intervention.