women with obesity. Overweight and obesity
Conditions
Interventions
Intervention 1: Intervention group 1: Oral daily intake of a 500-milliliter beverage containing water, aspartame (268 mg), and 80 mg of para-aminobenzoic acid (PABA) once a day for 3 months. Intervent
Sponsors
Swiss National Science Foundation
Eligibility
Sex/Gender
Female
Age
42 Years to 52 Years
Inclusion criteria
Inclusion criteria: Women between 42 and 52 years old BMI = 30 kg/m2 Stable weight (weight change =3 kg in the past 3 months) Presence of an intact uterus and at least one ovary Report of a menstrual cycle in the three months before screening Absence of pregnancy, lactation, or use of oral contraceptives or hormone therapy Willing to participate in the study.
Exclusion criteria
Exclusion criteria: History or diagnosis of thyroid disease (unless controlled by medication), type 1 or 2 diabetes mellitus, kidney disease, liver disease, cardiovascular disease, and chronic gastrointestinal disease History of recent infection and antibiotic use Smoking Consuming alcoholic drinks Taking medications that may affect body weight and composition, lipid profile and blood glucose control (including metformin, glibenclamide, atorvastatin, aspirin or other non-steroidal anti-inflammatory drugs), cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, or 3-hydroxy-3-methyl-glutaryl-CoA (HMG-CoA) reductase inhibitors, Being on a specific diet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbiome composition. Timepoint: At baseline and the end of intervention period. Method of measurement: Sequencing the 16s rDNA extracted from the stool samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin A1C. Timepoint: At baseline and the end of intervention period. Method of measurement: High-performance liquid chromatography method.;Fasting blood sugar. Timepoint: At baseline and the end of intervention period. Method of measurement: Laboratory kits.;Two-hour postprandial glucose. Timepoint: At baseline and the end of intervention period. Method of measurement: Laboratory kits.;Fasting serum insulin. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits.;Fasting serum Triglyceride. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits.;Fasting serum total cholesterol. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits.;Fasting serum high-density cholesterol. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits.;Fasting serum low-density cholesterol. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits.;Serum alkaline phosphatase. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits.;Serum gamma-glutamyl transferase. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits.;Serum aspartate aminotransferase. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits.;Serum alanine aminotransferase. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits.;Blood urea nitrogen. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits.;Serum Creatinine. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits.;Serum Follicle-stimulating hormone. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits.;Ser | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamidreza Raeisi-Dehkordi
Yazd University of Medical Sciences
Outcome results
None listed