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Overweight clinical trials

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NCT ID: NCT03813381 Completed - Clinical trials for Overweight and Obesity

CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO).

CARE-PRO
Start date: November 2015
Phase: N/A
Study type: Interventional

The increasing incidence of Esophageal Adenocarcinoma (EAC) in several Western countries can be primarily ascribed to risk factors such as obesity, chronic gastroesophageal reflux, dietary habits and alcohol intake. Nevertheless, Barrett's Esophagus (BE), remains the main risk factor for EAC. Several studies supports the role played by the gut microbiota on the modulation of metabolic and immunological pathways. An abnormal state of the microbial ecosystem seems to be involved in the promotion and onset of various diseases, including cancer. Recent studies have shown that diet and lifestyle have an important modulatory role as protective or risk factors for oncological diseases. The World Cancer Research Fund (WCRF) and the American Institute for Cancer Research (AICR) released a review of the evidence that emerged from published studies in the field of nutrition and cancer prevention and summarized their findings into 10 recommendations. Several studies have also shown that a moderate caloric and/or protein restriction seems to be able to reduce the risk of neoplastic disease development. The primary aim of this study is to evaluate the impact of a lifestyle-oriented intervention on body weight, waist circumference, biomarkers associated with cancer risk, esophageal microbiota composition and adherence to cancer prevention recommendations after 24 months in overweight or obese BE patients. Methods and analysis: Patients are randomly divided into two arms, a control arm (CA) and an interventional arm (IA). The CA receives information about a correct lifestyle to prevent cancer. The IA is involved in the two-year program of moderate caloric and protein restriction. At the time of enrollment, anthropometric measurements will be recorded for each patient and they will be randomized to IA or CA. Blood samples will be obtained from each patient and blood glucose will be determined. Serum metabolic biomarkers will be measured in each serum sample and total proteins will be extracted from fresh frozen esophageal biopsy and will be analyzed to evaluate the insulin signal pathway. To assess esophageal microbiota profiling, total genomic DNA (gDNA) will be extracted from matched fresh frozen biopsy. In order to determine a score of adherence to cancer prevention recommendations, participants will be asked to complete a self-administrated questionnaire reflecting WCRF/AICR recommendations. All the measurements will also occur at the end point, after two years from the enrollment.

NCT ID: NCT03812211 Completed - Clinical trials for Overweight and Obesity

Evaluation of a Supplement for Weight Management in Obese and Overweight Individuals

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this trial is to examine the effects of a novel, orally consumed dietary supplement (composed of naturally occurring components) on weight management and metabolic rate in individuals who are overweight or obese following a 12-week supplementation period. The investigator's primary outcome will be changes in body composition measured via dual energy x-ray absorptiometry (DXA), which will measure changes in fat and lean mass during the supplementation period. Another primary objective will be to determine whether or not the body mass index (BMI) changes during the supplementation period. A secondary objective of the study is to determine whether anthropometric measurements (waist-to-hip ratio) is altered following the supplementation period. Another secondary objective of this study is to determine whether metabolic rate (as measured in VO2 consumption at rest and during exercise) is changed following the supplementation period. Another secondary objective is to determine whether blood pressure (systolic and diastolic pressure, measured in mm Hg) and physical function (measured via VO2peak in mL/min/kg-1 and leg strength in kilograms) change when the supplement is administered over a 12-week period. Another secondary objective will determine how glycemic control, blood markers of inflammation and cholesterol are affected by this intervention.

NCT ID: NCT03811574 Completed - Obesity Clinical Trials

STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity

STEP 6
Start date: January 21, 2019
Phase: Phase 3
Study type: Interventional

This study will look at the change in participants' body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants are three times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a half years. Participants will have 14 clinic visits and 11 phone calls with the study doctor.

NCT ID: NCT03805802 Completed - Obesity Clinical Trials

Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes

Start date: February 4, 2019
Phase: N/A
Study type: Interventional

This study evaluates the effects of an ad libitum addition of a high fiber product to the regular diet of type 2 diabetes patients on body weight and blood sugar control. In the first 6 weeks half of the participants will receive the high fiber test product and half a reference product without fiber. After the first 6 weeks both groups will be switched to the high fiber product.

NCT ID: NCT03805295 Completed - Quality of Life Clinical Trials

Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA

Start date: February 16, 2018
Phase: N/A
Study type: Interventional

This study evaluates the implementation of the BOKS program in three schools (K-8) in Revere, MA, and its effect on participating students with regard to BMI, cognitive, and quality of life outcomes. BOKS (Build Our Kids' Success) is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools. Two sessions will be held (Spring 2018 and Winter 2018. This is a cohort study evaluating the impact of program participation on child BMI, quality of life, and executive function.

NCT ID: NCT03799146 Completed - Overweight Clinical Trials

Identifying the Effect and Working Mechanisms of MyPlan 2.0 in Older Adults

Start date: January 15, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to investigate whether and how 'MyPlan 2.0' helps older adults to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group.

NCT ID: NCT03792685 Completed - Clinical trials for Diabetes Mellitus, Type 2

Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention

Start date: September 24, 2009
Phase: N/A
Study type: Interventional

The objectives of this trial are to assess the effects of interactions between genetic factors and diet with various macronutrient intake on the metabolic disorders, obesity and type 2 diabetes risk, prevention, development and progress.

NCT ID: NCT03792282 Completed - Clinical trials for Overweight and Obesity

Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome (PCOS)

TRF-PCOS
Start date: January 7, 2019
Phase: N/A
Study type: Interventional

The aims of the present study is to examine whether Time-Restricted Feeding (TRF) is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese Polycystic ovary syndrome (PCOS) patients over 16 weeks compared to reduced energy restriction.

NCT ID: NCT03787225 Completed - Obesity Clinical Trials

A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity

Start date: January 7, 2019
Phase: Phase 1
Study type: Interventional

The aim of this study is to look at how the study medicine behaves in the participant's body and how it is removed from the participant's body. The study compares Japanese and Caucasian people who are normal weight, overweight or with obesity. The participants will either get NNC0174-0833 (a potential new medicine) or placebo (a "dummy" medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get 1 injection by a study nurse at the clinic. The injection will be with a needle in a skin fold in the participant's stomach area. The study will last for about 4 months, but duration of participation for any participant will last up to about 2 months. The participants will have 8 clinic visits with the study staff.

NCT ID: NCT03775278 Completed - Clinical trials for Otherwise Healthy Overweight or Obese

A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of PHP-303 in Otherwise Healthy Overweight or Obese Subjects

Start date: December 17, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose (MAD) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in otherwise healthy overweight or obese volunteer subjects. Within each ascending dose cohort, subjects will be randomized in a 4:1 ratio to receive PHP-303 or placebo. The primary objective is to establish the safety and tolerability and maximum tolerated dose (MTD) of orally-administered PHP-303.