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Body Weight clinical trials

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NCT ID: NCT04910620 Not yet recruiting - Weight Reduction Clinical Trials

The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults

Start date: June 15, 2021
Phase: Phase 4
Study type: Interventional

Obesity is a serious global public health issue. Many reports have showed that the use of appropriate probiotics can bring benefits to the health of the host and promote the balance of gut microbiota. Clinical experimental data show that the supplement of probiotics can help regulate gut function and weight control, and etc. TCI378 (Lactobacillus plantarum TCI378) is a probiotic extracted from Korean kimchi, and TCI507 (Lactobacillus plantarum TCI507) is a probiotic extracted from the oranges peels. These two strains of probiotics have been verified by in vitro experiments to have the effect of hydrolyzing bile salts, inhibition of the production of fat cells. Therefore, we want to evaluate whether the probiotics TCI308 and TCI507 have effects on reduction of body weight.

NCT ID: NCT04898439 Not yet recruiting - Cognitive Change Clinical Trials

GReen And Healthy Schools

GRAS
Start date: March 15, 2022
Phase: N/A
Study type: Interventional

This project aims to investigate the health effects of making schools greener and more biodiverse. We will mainly focus on cognitive effects, well-being, and BMI. The research hypothesis is that greening schools positively influences the health of children through more exercise and cleaner air.

NCT ID: NCT04793113 Not yet recruiting - Weight Loss Clinical Trials

A Study to Assess the Effects of Freshly Fit Meals on Body Weight and Wellness in Overweight and Obese Adults

Start date: March 15, 2021
Phase: N/A
Study type: Interventional

The primary objective of this trial is to examine the weight-loss efficacy of Freshly Fit meals, as well as body composition, waist/hip circumference, metabolic markers, and quality of life in overweight and obese adults.

NCT ID: NCT04674176 Not yet recruiting - Weight Loss Clinical Trials

Weight Loss Benefits of Rifaximin in an Intermittent Fasting Diet

Start date: January 1, 2021
Phase: Phase 4
Study type: Interventional

The epidemic of overweight and obese patients presents a major challenge in chronic disease prevention and overall health across the world. Since the beginning of this century, it is considered the third most important hazard attributable to burden of disease with approximately 350 million obese people (BMI ≥30.0) and over 1 billion overweight people (BMI ≥ 25) in the world. Mechanistic studies have indicated that the microbiota influences energy utilization from the diet and influences host genes that regulate energy expenditure and storage. Thus, it is proposed that alterations in gut microbiota may play a significant role in weight loss potential. This study seeks to expand on this idea by evaluating whether the incorporation of Rifaximin in an intermittent fasting (IF) diet plays a significant role in weight loss. Rifaximin is a nonsystemic antibiotic that works primarily in the gut to inhibit bacterial growth. It portrays unique eubiotic properties that induces a positive modulation of gut microbiota, favoring the growth of bacteria beneficial to the host without altering overall composition. Thus we propose an agent such as rifaximin would be essential in developing a positively altered gut microbiome. Based on studies evaluating Rifaximin's role in positive gut modification, we propose that this can play a critical role in weight loss. Rifaximin may be associated with weight loss as it exerts effects that increases the concentration of bacteria more prominent in lean individuals. The choice of incorporating an intermittent fasting (IF) diet, stems from its success in prior studies. By incorporating periods of voluntary abstinence from food and drink, an IF diet has shown short term weight loss among overweight and obese people. We propose that an IF diet with an antibiotic, like Rifaximin, will create more positive alteration in gut microbiota that creates a greater potential for weight loss overall. A group of subjects with BMI's ranging from 30-35 will be randomly selected and assigned to an experimental and control group. Each subject will be given clear instructions on how to follow a 14:10 intermittent fasting diet, in which they will fast for 14 hours and be able to eat for 10 hours a day. Patients in the experiment group will additionally receive a short-term low dosage of Rifaximin at the start of their diet. Patients will be evaluated with weekly weigh-ins and basic blood work performed at the start and at the completion of the study. The current hypothesis does not incorporate microbiome evaluation due to cost of the kits and limited funding available for the study.

NCT ID: NCT04526847 Not yet recruiting - Clinical trials for Overweight and Obesity

Intermittent Fasting Compared to Continuous Energy Restriction on Body Weight Loss

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

Obesity remains a major public health challenge. Intermittent fasting continues to gain popularity compared to continuous energy restriction as a weight-loss approach for cardiometabolic health. Studies to date comparing intermittent energy restriction (IER) and continuous energy restriction (CER) have not been investigated on weight loss and cardiometabolic risk markers in low-income countries like Nepal. The main objective of this study is to compare the effectiveness of IER versus CER diet on weight loss and cardiometabolic risk markers over the course of six months among overweight/obese Nepalese population. This study will adopt a parallel arm, open-label, randomized control trial design. The study duration will be six months from baseline to endline. A total of 112 overweight and obese participants, aged 18-64 years, with waist circumference >90 cm (men) and >80 cm (women) will be enrolled in the study. Interested participants will be approached through social media and consecutively enrolled and assigned to either IER group (n=56) or CER group (n=56) randomly. Participants will be provided Mediterranean pattern dietary intervention including two groups: IER group will receive 5:2 diet pattern (5 day without energy restriction and 2 days with 75% energy restriction, net weekly energy deficit ~25%), and CER group with a low-calorie diet (daily energy deficit ~25%) over the course of six months. Both IER and CER group will be provided personalized diet plan, portion size, nutrition counseling focus on dietary guidance, motivational strategies, and personal goal setting for behavior change with educational materials. Baseline data will be collected using a structured questionnaire and the biochemical tests will be done. Baseline data will be collected at the time of enrollment, midline in three months, and end-line data collection in six months. The primary outcome of this study will be the change in weight loss between IER and CER groups. The secondary outcome measure will be to evaluate changes in nutritional composition, eating behavior, and cardiometabolic risk markers between IER and CER group over six months. Data will be entered using Epidata Software and transferred to the Stata/MP version 14.1 for further analysis. Data will be analyzed using an intention-to-treat basis. Independent t-test and, repeated measures ANOVA will be used to estimate changes between-group comparisons. The significance level will be assumed at p<0.05

NCT ID: NCT04464278 Not yet recruiting - Body Weight Changes Clinical Trials

Variation in Body Composition on the Fate of Older Subjects During SSR Hospitalization

VALCOR
Start date: July 2020
Phase:
Study type: Observational

The aim of this study is to correlate weight variation as well as body composition with mortality and unscheduled readmission of geriatric population

NCT ID: NCT04458493 Not yet recruiting - Weight Loss Clinical Trials

Does Meal Replacement With a Carbohydrates and Protein Supplement Induce Weight Loss in Overweight and/or Obese Adults?

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

Participants will be randomized into two groups, one group will be the control (no intervention at all) and the other will be CHO-PRO (meal replacement, Generation UCAN supplement, 400ml, 20% solution). Prior to the start of the experiment, all participants will be asked to record their satiety ratings, appetite and desire to eat (10-point visual analogue scale) 30, 60 and 120 minutes after their regular dinner for 3 days. On the first day of the experiment, all participants will be asked to measure their waist and hip circumferences, fasting blood glucose level, maximal number of pushups and body weight using a scale at home prior to breakfast. Instructions on how to do the measurements properly will be recorded in a video and distributed to the participants. Participants in the control group will not receive any intervention. Participants in the CHO-PRO group will be provided with the supplement and they will be asked to consume the CHO - protein supplement (Generation UCAN supplement, 250ml, 10% solution) 6 to 7 hours after lunch, in place of their dinner for 6 weeks. They will also be asked to record their satiety ratings, appetite and desire to eat (10-point visual analogue scale) 30, 60 and 120 minutes after each meal replacement drink. All participants will be required to complete a dietary record, prior to, and during (at weeks 2 and 4) intervention. To track adherence of the CHO-PRO group, participants will be asked to check off the calendar that they did not consume the meal replacement due to various reasons. On day 43, all participants will be asked measure again waist and hip circumferences, fasting blood glucose level, maximal number of pushups and body weight using a scale at home prior to breakfast again.

NCT ID: NCT04173559 Not yet recruiting - Pregnancy Related Clinical Trials

Sleep and Tracking Effects in Pregnancy Study

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

Purpose: The investigators hypothesize that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women reduce their stress during pregnancy. Participants: Pregnant women enrolled in prenatal care at the University of North Carolina who have a documented moderate or high level of perceived stress ( ≥ 14) and are at high risk for adverse pregnancy outcomes due to body mass index of ≥ 30 kg/m2 or history of gestational hypertension, preeclampsia, intrauterine growth restriction, or preterm birth <37 weeks' in a prior pregnancy. Procedures: Women meeting inclusion criteria will be recruited through the University of North Carolina prenatal care clinics. They will be contacted for possible participation at regularly scheduled prenatal visits and/or ultrasound. They may also be contacted for possible participation by remote methods (e.g., Telehealth). Women who are enrolled will complete validated dietary, stress, sleep, and body image questionnaires. Enrolled women will then be randomized to receive standard obstetrical care or enhanced counseling. All participants will receive a wrist-based activity tracker. Maternal blood sample for biochemical markers of stress and gene expression will be obtained at the initial visit; a followup blood sample will be obtained later in pregnancy, and a small portion of the placenta saved at delivery. Maternal and neonatal outcomes will be compared between groups.

NCT ID: NCT03996356 Not yet recruiting - Weight Gain Clinical Trials

Clozapine Induced Weight Gain

Start date: March 2020
Phase:
Study type: Observational

Clozapine is prescribed to patients with psychosis in whom other treatments have not worked. Research has shown, however, that clozapine may be associated with weight gain and abnormal blood sugar levels in some patients. There is strong evidence to suggest that genetic variation between individuals plays an important role in the development of these side effects in response to the medication. Our research aims to evaluate the effects of two genes and the blood level of clozapine on side-effects such as weight changes and blood sugar levels in patients receiving clozapine treatment. From out-patient clinics in Cwm Taf UHB, the investigators aim to recruit 160 patients who are taking clozapine; collect information/ measurements from recruits relating to size/ weight/ BMI, risk of diabetes and blood samples to measure markers of blood sugar, fat/lipids, clozapine and its breakdown products, blood cells and variants of two specific genes. From this information the investigators will be particularly interested to understand if there is any association between the variation in these two genes with weight gain or changes in blood sugar, in patients taking clozapine.

NCT ID: NCT03872245 Not yet recruiting - Weight Loss Clinical Trials

Association of Probiotics With Neurostimulation of Dermatome T6: Effect on Weight Loss in Obese Patients

Start date: March 11, 2019
Phase: Phase 3
Study type: Interventional

Patients will be randomized into 2 groups: - Group 1:Patients undergoing PENS T6, who also received Probiotics, during 10 weeks. - Group 2: Patients undergoing PENS T6 during 10 weeks. They will not received Probiotics Weight loss after 10 weeks of treatmente will be assessed.