Overweight
Conditions
Interventions
This is a randomized, placebo-controlled clinical trial with two parallel arms. Adult individuals of both sexes, residing in Viçosa, Minas Gerais (MG), or surrounding areas will participate in the pre
Sponsors
Universidade Federal de Viçosa
Florida Research Group LLC.
Eligibility
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: Participants in this study will be adult individuals of both sexes, residing in Viçosa/MG or surrounding areas, who have not received nutritional follow-up in the past six months and who present health risks associated with obesity, according to the following criteria: Body fat percentage = 20% for men and = 30% for women; Age between 30 and 60 years; Waist circumference (men = 90 cm, women = 80 cm), plus at least two of the following criteria: High-density lipoprotein (HDL) cholesterol (men = 40 mg/dL, women = 50 mg/dL); triglycerides = 150 mg/dL; Blood pressure = 130/85 mmHg.
Exclusion criteria
Exclusion criteria: Pregnant or lactating women, as well as postmenopausal women, will not be included; athletes; shift workers; individuals with physical and/or intellectual disabilities; those with food intolerances or allergies; individuals with diabetes mellitus; autoimmune diseases or those using immunosuppressive drugs (e.g., HIV, rheumatoid arthritis, lupus); hormonal disorders (hyperthyroidism or hypothyroidism, Cushing’s syndrome); gastrointestinal diseases or disorders (gastritis, ulcers, esophagitis, dysphagia, chewing difficulties); individuals with inflammatory bowel diseases (ulcerative colitis, Crohn’s disease, diverticulitis, celiac disease, irritable bowel syndrome); hepatic diseases (liver failure, hepatitis, cirrhosis), renal diseases (chronic kidney disease), pancreatitis, cardiovascular diseases (angina, acute myocardial infarction, congestive heart failure), eating disorders (anorexia, bulimia, binge eating disorder); cancer; recent infectious episode within the past month; history of illicit drug use and/or alcohol consumption > 21 and > 14 units/week for men and women, respectively; previous bariatric surgery; body weight instability (= 5% change in usual body weight) in the last three months; adherence to vegan, vegetarian, or restrictive diets; use of anti-inflammatory drugs, corticosteroids, antipsychotics, or antidepressants that may affect appetite and/or energy metabolism; use of vitamin, mineral, or omega-3 supplements; and use of fiber supplementation (e.g., psyllium, inulin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Ursolinol® on adiposity and cardiometabolic risk biomarkers in individuals with overweight or obesity. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of supplementation on cardiometabolic risk markers. | — |
Countries
BR
Contacts
Public ContactHelen Hermana Hermsdorff
Universidade Federal de Viçosa
Outcome results
None listed