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Body Weight clinical trials

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NCT ID: NCT05939453 Recruiting - Body Weight Clinical Trials

Impact of Bright Light Therapy on Prader-Willi Syndrome

PWS-LT
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome

NCT ID: NCT05906771 Recruiting - Clinical trials for Cardiovascular Diseases

Study of the Effect of the Combined Extract of Lemon Verbena and Hibiscus on Health Indicators

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Plant polyphenols have demonstrated the ability to ameliorate metabolic alterations induced by overweight and obesity, both in cellular and animal models, where most therapeutic approaches have failed. These have demonstrated the ability to improve appetite sensation, leading to improved body weight control, in addition to reducing fat accumulation and improving plasma glycemic and lipid profiles, as well as inflammatory process and vascular dysfunction. The plant polyphenols on which the extract to be studied will be based will be hibiscus and lemon verbena. A randomized controlled trial will be carried out in overweight or obese subjects from the province of Alicante. An electronic randomization will be carried out based on a two-branch design, therefore, there will be a control group (no intervention) and an experimental group (nutraceutical intake). Participants will have to ingest the nutraceutical for 3 months, as well as attend the agreed visits. Different satiety questionnaires, circulating parameters measured in capillaries (cholesterol, triglycerides and glucose), blood pressure and body composition measured by bone densitometry (DXA) will be collected. All variables will be measured at 4 different time points (baseline, 30 days, 60 days and 90 days). All these will be analyzed as a function of time; at the beginning and end of each intervention (intra-group analysis), as well as comparing the control group with the experimental group (inter-group analysis). A multidisciplinary team formed by physicians, nurses and nutritionists will be involved.

NCT ID: NCT05899205 Recruiting - Cancer Clinical Trials

Patient Recorded Indexing Measurements

PRIMs
Start date: June 1, 2021
Phase:
Study type: Observational

Rationale: One of the greatest challenges in the field of cancer treatment is cachexia, a multifactorial syndrome characterized by substantial loss of body weight (muscle and fat mass), leading to progressive functional impairment. Cancer cachexia significantly impairs quality of life and survival as well as treatment outcome. Despite its considerable relevance for the prognosis of cancer patients, the diagnosis of cachexia is problematic. The current consensus definition of cancer cachexia is based on weight loss over the last six months. In practice, this is assessed by subjective reporting by the patient, which is subject to error and bias. Novel technologies enable accurate, standardized, and objective assessment of body weight and physical activity by newly diagnosed cancer patients in the home situation. Because of the increasing implementation of neo-adjuvant treatment strategies that offer an extended time-window for the collection of these data, there is a great opportunity to use this information in risk analyses by treating physicians, optimization of pre-habilitation programs, and in the shared-decision making process with the patient. Objective: The primary objective of this study is to obtain accurate data regarding physical activity, body composition, and body weight loss over time in patients with gastric, esophageal, rectal, pancreatic, or ovarian cancer in relation to treatment outcome, adverse events (chemotoxicity and/or surgical complications), and survival. Study design: Explorative pilot study Study population: Patients between 18 and 80 years old undergoing surgical resection or neo-adjuvant chemotherapy for the treatment of gastric, esophageal, rectal, ovarian, or pancreatic cancer. Main study parameters/endpoints: Objective data acquisition on activity (three axis acceleromotion using a wrist-worn accelerometer), body weight (at home measurement with memory integrated weight scale), and body composition in relation to treatment outcome, evaluated using RECIST, adverse events, assessed via chemotoxicity and surgical complications using the Clavien-Dindo classification, and length of hospital stay in gastric, esophageal, rectal, pancreatic, and ovarian cancer patients. Secondary endpoints: To assess body weight changes and physical activity in relation to survival.

NCT ID: NCT05890365 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals

Start date: December 14, 2023
Phase:
Study type: Observational

The investigators recently demonstrated a increase in liver fat in early middle-aged LBW compared to normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). Here the investigators will further examine the Increased risk of non-alcoholic fatty liver disease in low birth weight individuals by performing a validation study.

NCT ID: NCT05889767 Recruiting - Obesity Clinical Trials

Exercise-Induced Gut Permeability in Normal-weight Obesity

Start date: January 10, 2023
Phase: N/A
Study type: Interventional

Exercise acutely increases gut permeability and inflammation, even in healthy populations. However, whether this response differs in groups at-risk for CVD that present with low-grade inflammation (e.g., normal-weight obesity) has yet to be examined. The investigators aim to measure serum indicators of gut permeability in those with normal-weight obesity pre- and post-short, intense exercise and sustained, moderate exercise

NCT ID: NCT05869799 Recruiting - Overweight Clinical Trials

Effect of Vigiis 101 Lactic Acid Bacteria Powder on Body Weight and Body Fat in Overweight Participants

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (14 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)

NCT ID: NCT05855551 Recruiting - Clinical trials for Gestational Weight Gain

Improving Birth Outcomes in Bangladesh

Start date: May 25, 2023
Phase: N/A
Study type: Interventional

Maternal undernutrition is a global public health problem with far-reaching effects for both mothers and infants. Poor maternal nutrition negatively affects fetal growth and development. Both micro and macro-nutrients are required for the physiological changes and increased metabolic demands during pregnancy, including fetal growth and development. Women in Bangladesh have poor diets and are struggling to meet their nutrient requirements, especially during pregnancy and lactation when requirements are higher. Maternal undernutrition during pregnancy is associated with a range of adverse birth outcomes, including stillbirths, preterm births, low birthweight, and small-for-gestational-age (SGA) neonates, all of which remain unacceptably high in Bangladesh. Social protection provides a promising platform on which to leverage improvements in nutrition at scale, but current evidence on the impacts of social protection on birth outcomes is limited: few studies have been conducted and some of these studies suffer from methodological limitations. The planned study will contribute to filling this knowledge gap. An additional motivation for the study is provided by the recent WHO 2016 Antenatal Care Guidelines. The guidelines call for studies on the effectiveness of alternatives to providing energy and protein supplements to pregnant women (which is recommended in undernourished populations). Studying the effectiveness of providing combinations of food and cash will help build this evidence base. A third reason to conduct the study is that both food transfers and cash transfers are commonly used policy instruments in Bangladesh, and the choice of intervention components to scale up in the CBP will be guided by the findings from this pilot study. The study findings will thus be highly policy relevant. A three-arm cluster-randomized, non-masked, community-based, longitudinal trial will be used. Groups of pregnant women will be randomly assigned to one of three study arms providing different combinations of cash and food transfers.

NCT ID: NCT05845866 Recruiting - Clinical trials for Overweight and Obesity

Targeting Weight and Shape Concern Among Women With High Body Weight

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial to evaluate the effect of an adapted version of the Body Project program among adult women of higher body weight who want to lose weight. The study will evaluate treatment effects on weight and shape concern and explore the impact of intervention on weight loss outcomes.

NCT ID: NCT05842954 Recruiting - Clinical trials for Uncomplicated Plasmodium Falciparum Malaria

Efficacy, Safety and Tolerability of KLU156 in Adults and Children ≥ 5 kg Body Weight With Uncomplicated P. Falciparum Malaria

KALUMA
Start date: March 7, 2024
Phase: Phase 3
Study type: Interventional

This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection). In the Extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure (ETF), who did not experience any study treatment-related SAE (Serious Adverse Event) previously and who gave informed consent to participate in the Extension phase.

NCT ID: NCT05826184 Recruiting - Weight, Body Clinical Trials

Time Restricted Eating With or Without a Fiber Supplement for Weight Management in Pediatric Cancer Survivors

Start date: November 17, 2023
Phase: N/A
Study type: Interventional

This study aims to address a critical gap in pediatric oncology survivorship care by exploring innovative solutions to addressing obesity and its comorbidities in pediatric cancer survivors. The majority (99%) of pediatric cancer survivors will develop severe chronic health conditions by age 50, with 96% developing at least one severe/disabling, life threating or fatal chronic health condition. Obesity, cardiovascular, and metabolic diseases are the most common treatment-related late effects among pediatric cancer survivors. Improving diet and reducing obesity has the potential to dramatically improve the quality of life and long-term health of pediatric cancer survivors. Utilization of a prebiotic fiber supplement along with TRE amy improve the gut microbiome, short-chain fatty acid synthesis, and hunger hormones to further improve weight loss with TRE and a greater decrease in cardiometabolic risk. The aims of this study are to test the safety, feasibility, and acceptability of 8-h TRE or 8-h TRE with a fiber supplement among young adult (YA) pediatric cancer survivors. The investigators further strive to examine the preliminary efficacy of TRE on body weight, body composition, glucose regulation, and cardiovascular risk markers. Data obtained will be used to inform a larger efficacy trial of TRE among adolescent and young adult pediatric cancer survivors. Given that a majority of pediatric cancer survivors will develop severe chronic health conditions by age 50, with 96% developing at least one severe/disabling, life threating or fatal chronic health condition exploring accessible nutritional strategies to improve long term health trajectory of 70,000+ AYA diagnosed with cancer each year in the United States. This study of TRE will provide important preliminary evidence of the benefits of this nutrition therapy for YA pediatric cancer survivors. The long-term goal of this line of inquiry is to improve both short and long-term outcomes for YA pediatric cancer survivors.