Overweight
Conditions
Interventions
This is a single-blind, randomized, parallel, controlled clinical trial conducted with 56 overweight or obese adult women, aged between 30 and 60 years, equally distributed into two arms of the study,
Sponsors
Departamento de Nutrição e Saúde da Universidade Federal de Viçosa
Departamento de Nutrição e Saúde da Universidade Federal de Viçosa
Eligibility
Sex/Gender
Female
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: Women; aged 30 to 60 years; Body Mass Index classification as overweight and obesity; elevated waist circumference (greater than or equal to 80 cm for women) and excess body fat (greater than 32% for women)
Exclusion criteria
Exclusion criteria: Women under 30 years of age; Men; Body Mass Index (BMI) less than 30 kg/m²; athletes; shift workers; people with physical and/or intellectual disabilities; people who have undergone bariatric surgery; those with weight instability (5% of usual weight) in the last three months; those following a vegan, vegetarian, or restricted diet (e.g., gluten-free and lactose-free); pregnant and breastfeeding women; patients with type 1 Diabetes Mellitus; autoimmune or immunosuppressive diseases (HIV, rheumatoid arthritis, lupus); hormonal diseases (hyperthyroidism or hypothyroidism, Cushing's syndrome); digestive diseases or disorders (gastritis, ulcer, esophagitis, dysphagia, difficulty chewing); those with inflammatory bowel diseases (ulcerative colitis, Crohn's disease, diverticulitis, celiac disease, irritable bowel syndrome); Liver disease (liver failure, hepatitis, cirrhosis), kidney disease (chronic kidney disease), pancreatitis, cardiovascular disease (angina, acute myocardial infarction, congestive heart failure), eating disorders (anorexia, bulimia, binge eating disorder) or cancer; history of illicit drug use and/or alcohol consumption above 21 units/week; use of hormone replacement therapy; use of products enriched with prebiotics or probiotics (at least three weeks before screening) and use of fiber supplements (psyllium, inulin) or ingestion of large quantities of fermented foods (greater than 400 g/day); aversion or allergy to nuts; infectious episode in the last month; use of anti-inflammatory drugs, corticosteroids, antibiotics and others that may affect appetite and energy metabolism; habitual consumption of nuts above 30 g/day; consumption of vitamin, mineral and omega-3 supplements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvements in intestinal health markers are expected in overweight or obese women after 12 weeks of intervention, verified through analysis of gut microbiota composition and intestinal function. This will be achieved by evaluating the taxonomic composition of the gut microbiota at the phylum, order, genus, and species levels, as well as alpha and beta diversity, intestinal permeability through serum concentrations of D-lactate, lipopolysaccharide-binding protein, zonulin, and intestinal fatty acid-binding protein, in addition to quantifying short-chain fatty acids and measuring fecal hydrogen ion potential. The outcome will be considered to have occurred based on the observation of significant differences between the values ??obtained in the pre-intervention and post-intervention periods.;Improvements in neuroendocrine control markers are expected after 12 weeks of intervention, verified by quantifying serum concentrations of leptin, adiponectin, peptide YY, neuropeptide Y, agouti-related protein, and glucagon-like peptide 1, analyzed by enzyme immunoassay method, with the outcome considered to have occurred based on the observation of significant differences between the values ??obtained in the pre-intervention and post-intervention periods;An improvement in inflammatory markers is expected after 12 weeks of intervention, verified by quantifying serum concentrations of interleukin 6, interleukin 10, interleukin 1 beta, interleukin 8, and tumor necrosis factor alpha, analyzed by flow cytometry using commercial kits from BD Biosciences, with the data processed using FCAP Array software version 3.0. The outcome is considered to have occurred based on the observation of significant differences between pre-intervention and post-intervention values;Improvements are expected in body composition, especially in total body fat, visceral fat, and muscle mass.;An improvement is expected in cardiometabolic risk markers: total cholesterol, HDL-c, LDL-c, triglycerides, glucose, | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected. | — |
Countries
BR
Contacts
Public ContactAna Claudia Kravchychyn
Universidade Fedral de Viçosa
Outcome results
None listed