Clinical Research Directory

Changes in Body Composition Following Pharmacological Treatment for Obesity.

Background: Intentional weight loss via various treatments results in a loss of lean mass of approximately 10% for every 10 kg of total weight lost. There is a paucity of data regarding changes in skeletal muscle mass associated with the novel anti-obesity drugs becoming available-specifically concerning not only quantitative changes but also the potential impact on muscle strength and the ability to perform activities of daily living. Objectives: 1) To determine changes in body composition in individuals with obesity treated with semaglutide or tirzepatide for a period exceeding 6 months. 2) To analyze the impact of these changes on muscle strength and function. Methodology: A prospective, multicenter study coordinated by the Obesity Section of the Spanish Society of Endocrinology and Nutrition (SEEN). The study includes individuals with obesity (without diabetes) undergoing pharmacological treatment with semaglutide or tirzepatide. Body composition is analyzed via bioimpedance before and after treatment. Muscle strength is assessed using handgrip dynamometry and the chair-stand test. Exploratory analyses cover weight loss percentage, weight loss categories, changes in fat mass and fat-free mass (kg and %), and estimates of total and appendicular skeletal muscle mass. Optional sub-studies include abdominal ultrasound (to measure subcutaneous and preperitoneal adipose tissue thickness) and ultrasound of the rectus femoris muscle. Data on side effects, diet, exercise, and quality of life are also recorded. Planned analyses include weight loss percentages, changes in variables following pharmacological treatment, adjustments for confounding variables (age, sex, protein intake, structured physical activity, etc.), and exploratory uni- and multivariate logistic regression analyses.

Investigation of Egg Intake and the Relationship Between Gut Microbiome, Metabolic, and Immune Profiles

The purpose of this intervention study is to investigate the effects of daily egg intake on markers of gut health, high-density lipoprotein (HDL), metabolic, and immune cell profiles in adults with body mass indexes (BMI) in normal and obesity ranges. This study further aims to determine whether egg effects are associated with baseline gut microbiome profiles, and whether egg effects are different between males and females and by BMI status. The study will address the following objectives: Objective 1: Evaluate the effects of daily egg white vs. whole egg intake on gut health, microbiome, and metabolome profiles. Objective 2: Evaluate the effects of daily egg white vs. whole egg intake on HDL composition and function. Objective 3: Evaluate the effects of daily egg white vs. whole egg intake on immune profiles and function in culture (ex vivo). Participants will be asked to consume egg whites and whole eggs on a daily basis for 4-weeks each, and avoid eating eggs for a total of 8 weeks at different points in the study. Participants will be asked to complete surveys about dietary intake and physical activity, as well as provide blood and stool samples throughout the course of the study.

A PHASE 2A, EXPLORATORY, RANDOMIZED, SINGLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY OF WEIGHT LOSS INDUCED BY NKS-3 IN OBESE ADULTS.

This study is designed as a single-blind, placebo-controlled, randomized, parallel-group trial. Subjects will be randomized in a 2:1 ratio to receive either NKS-3 or matching placebo, with a total planned enrollment of 31 subjects. During the 90-day treatment period, subjects will self-administer the assigned blinded study treatment daily at home. Given the exploratory nature of the study, which is intended to assess the feasibility of and generate preliminary evidence supporting the study hypothesis, a single-blind design has been selected. This approach reduces the logistical and organizational complexity associated with implementing a double-blind design while maintaining blinding of study participants to minimize expectation bias. Considering the exploratory objectives of the study, the selected design is considered appropriate and is not expected to compromise the scientific validity or the safety of participants.

Time-Restricted Eating and Personalized Energy-Restricted Diet in Obese Postmenopausal Women

This clinical study aims to compare the effects of time-restricted eating and a personalized energy-restricted diet on anthropometric measurements, body composition, biochemical parameters, blood pressure, handgrip strength, menopausal symptoms, and sleep quality in obese postmenopausal women. The study is a 12-week, open-label, controlled, parallel-group clinical trial with a quasi-randomized allocation design. The coordinating center is the Department of Internal Medicine, Faculty of Medicine, Gazi University, and the study will be conducted at the Internal Medicine Outpatient Clinic of Cihanbeyli State Hospital in Konya, Türkiye. A total of 40 postmenopausal women are planned to participate, with 20 participants in each group. Participants will undergo an initial medical examination and baseline assessments, including demographic and health information, dietary habits, menopausal symptoms, sleep quality, physical activity, and dietary intake. Anthropometric measurements, body composition, handgrip strength, blood pressure, and biochemical parameters will also be assessed. Participants in the intervention group will follow a time-restricted eating schedule in which they will consume food within an 8-hour daily eating window and fast for 16 hours. The eating window will begin between 8:00 AM and 12:00 PM and will be determined by the participant. During the fasting period, water, unsweetened tea, plain coffee, and plain mineral water will be permitted. Participants in the control group will follow a personalized energy-restricted diet providing approximately 25% less energy than their estimated energy requirements. The diet will be planned according to menopausal nutrition recommendations and individual preferences. Dietary intake will be monitored every 2 weeks. Anthropometric measurements, blood pressure, and handgrip strength will be assessed every 4 weeks. All baseline assessments will be repeated after the 12-week intervention period. The study hypothesis is that time-restricted eating will result in greater improvements than the personalized energy-restricted diet in anthropometric measurements and body composition, biochemical parameters, blood pressure, handgrip strength, menopausal symptoms, and sleep quality in obese postmenopausal women.

Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes

This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus placebo in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.