Obesity. Overweight and obesity
Conditions
Interventions
Intervention 1: Intervention group: The reduced added sugar group will be provided with a list of foods containing added sugars to help them limit their daily added sugar intake to a maximum of 25 gra
Sponsors
Oroumia University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age range over 18 years from both genders BMI between 35 and 45 kg/m
Exclusion criteria
Exclusion criteria: Having special dietary plans Pregnancy and breastfeeding during the study Alcohol consumption Diabetes mellitus Unstable weight: defined as a change (increase or decrease of more than 5% of body weight) during the 3 months prior to enrollment in the study. Smoking consumption Hyperlipidemia Chronic diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum leptin level. Timepoint: Serum leptin levels will be measured at weeks 0 and 12. Method of measurement: Approximately 5 mL of fasting venous blood will be collected in the morning, the serum will be separated, and leptin concentration will be measured using an ELISA (Enzyme-Linked Immunosorbent Assay) kit according to the manufacturer’s instructions.;Fasting blood glucose. Timepoint: Measurement time points: at weeks 0 (baseline) and 12 (end of intervention) after 10–12 hours of overnight fasting. Method of measurement: Measurement method: measured in fasting serum samples using an enzymatic colorimetric method with commercial kits on an autoanalyzer (BT1500).;Fasting serum insulin. Timepoint: Measurement time points: at weeks 0 (baseline) and 12 (end of intervention) after 10–12 hours of overnight fasting. Method of measurement: Measurement method: Fasting serum samples will be analyzed using an ELISA kit and an ELISA Reader (Stat Fax 4200) according to the manufacturer’s instructions.;Glycated hemoglobin (HbA1C). Timepoint: At weeks 0 (baseline) and 12 (end of intervention) after 10 to 12 hours of overnight fasting. Method of measurement: Fasting serum samples will be analyzed using commercial kits from Delta Tehran Part Company and the BT1500 Autoanalyzer according to the manufacturer’s instructions; results will be reported as a percentage (%).;HOMA-IR (Homeostatic Model Assessment for Insulin Resistance. Timepoint: HOMA-IR will be calculated at baseline and week 12 after 10–12 hours of overnight fasting. Method of measurement: It will be calculated based on fasting insulin and glucose values using the following formula.;QUICKI (Quantitative Insulin Sensitivity Check Index). Timepoint: QUICKI will be calculated at baseline and week 12 after 10–12 hours of overnight fasting. Method of measurement: It will be calculated based on fasting insulin and glucose values using the following formula.;Total Cholesterol. Timepoint: Total cholesterol will be measured at | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in energy and macronutrient intake. Timepoint: At weeks 0, 6, and 12. Method of measurement: Based on FFQ and 24-hour dietary recall.;Physical activity level. Timepoint: At weeks 0, 6, and 12. Method of measurement: Based on the METs questionnaire.;Gene–Diet Interaction. Timepoint: At weeks 0 and 12. Method of measurement: Assessed by comparing changes in serum leptin and metabolic indices across different LEP rs7799039 and LEPR rs1137101 genotypes using statistical interaction analysis. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeid Ghavamzadeh
Oroumia University of Medical Sciences
Outcome results
None listed