]>
IRCT20130223012571N7 IRCT 2021-03-08 Swiss National Science Foundation Non-caloric sweeteners, microbiome, and cardiometabolic risk - a randomized clinical trial of Iranian women The effect of non-caloric sweeteners compared with sucrose on the gut microbiome, cardiovascular risk factors, and sex hormones in women with obesity 2021-06-22 anticipated 160 Complete https://irct.ir/trial/54506 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: An independent statistician will use a statistical software [statistical package for social sciences (SPSS)] which generates random numbers to block-randomize participants into one of the four trial groups (labeled as A, B, C, and D), ensuring that all the subjects will receive treatments in a balanced and random order. Each label will be assigned to one of the four sweeteners used as treatment (aspartame, saccharine, steviol glycosides, and sucrose), Blinding description: The concealment will be done by putting the randomly assigned group for each participant in sealed envelopes. The allocation concealment will be conducted by an independent researcher. The four tested beverages will be provided in the same sweetness, shape, color, and appearance and will be packed in the same bottles. In addition, natural flavorings with similar color, appearance, taste, and texture will be added to all of the four treatment groups by an independent researcher from the Department of Pharmaceutics, School of Pharmacy, Shahid Sadoughi University of Medical Sciences. Participants and administrators will be unaware of the content of the bottles until data analyses. All bottles will be labeled with four codes (A, B, C, and D) by a responsible person who is not aware of the study objectives. The codes will not be released until after the statistical analyses; therefore, neither the study participants nor the personnel and the data analysts will be aware of the intervention bottles. 3 women with obesity. 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. Intervention 2: Intervention group 2: Oral daily intake of a 500-milliliter bottle beverage containing water, saccharin (125 mg), and 80 mg of para-aminobenzoic acid (PABA) for 3 months. Intervention 3: Intervention group 3: Oral daily intake of a 500-milliliter beverage containing water, steviol glucosides (200 mg), and 80 mg of para-aminobenzoic acid (PABA) for 3 months. Intervention 4: Control group: Oral daily intake of a 500-milliliter beverage containing water, sucrose (50 g), and 80 mg of para-aminobenzoic acid (PABA) for 3 months. Yes - There is a plan to make this available What will be shared: We plan to register and deposit data that relates to individual primary publications and not the whole study database. This enables other researchers to replicate published analyses and results as well as to re-use the data for additional analyses such as meta-analysis. General characteristics of participants (without the identity of the participants) as well as baseline and after-treatment data values of primary and secondary outcome variables, will become available for researchers after a request from interested investigators. When: Data will be available after the individual, related papers become published. To whom: Data will become available for all investigators interested in the subject. Conditions: All efforts will be made to protect the privacy and to de-identify the data. Therefore, data will be shared on request under the following conditions: - A meaningful study question by the requester - Outline of the planned analyses - Valid methodology - Signed data sharing agreement that contains a confidentiality agreement and approval of the study team members. Where to obtain: The data can be obtained from principal investigators: - Principal investigator from Iran: Dr. Amin Salehi-Abargouei, MSc, Ph.D. in Nutrition. Department of Nutrition Faculty of Public Health Sahid Sadoughi University of Medical Sciences Yazd, PO Code 8915173160 Iran, Tel:+98-35-31492229, Fax:+98-35-38209119, Email: abargouei@ssu.ac.ir Alternate email: abargouei@gmail.com - Principal investigator from Switzerland: Prof. Oscar Franco, MD, Ph.D., FESC, FFPH. Professor of Epidemiology & Public Health. University of Bern, Mittelstrasse 43, 3012 Bern, Switzerland, Tel +41316313350 Email: oscar.franco@ispm.unibe.ch How to obtain: The interested investigators should provide a brief description of the data needed and their reason for asking for the data by contacting principal investigators. They will assess the possibility of sharing the data and if applicable will ask for a signed data sharing agreement that contains a confidentiality agreement and approval of the study team members. Comments:
public Hamidreza Raeisi-Dehkordi
Department of Nutrition, School of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 hamidreza92nut@gmail.com Yazd University of Medical Sciences scientific Dr. Amin Salehi-Abargouei
Department of Nutrition, School of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 abargouei@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) 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. 42 years 52 years Female 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 E66 Overweight and obesity Treatment - Other Treatment - Other Treatment - Other Treatment - Other 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 Intervention group 2: Oral daily intake of a 500-milliliter bottle beverage containing water, saccharin (125 mg), and 80 mg of para-aminobenzoic acid (PABA) for 3 months Intervention group 3: Oral daily intake of a 500-milliliter beverage containing water, steviol glucosides (200 mg), and 80 mg of para-aminobenzoic acid (PABA) for 3 months Control group: Oral daily intake of a 500-milliliter beverage containing water, sucrose (50 g), and 80 mg of para-aminobenzoic acid (PABA) for 3 months Gut microbiome composition. Timepoint: At baseline and the end of intervention period. Method of measurement: Sequencing the 16s rDNA extracted from the stool samples. 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. Serum testosterone. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits. Serum estradiol. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits. Serum estriol. Timepoint: At baseline and the end of the intervention period. Method of measurement: Laboratory kits. Weight. Timepoint: At baseline, 1 month, and the end of the intervention period. Method of measurement: Body composition analyzer. Waist circumference. Timepoint: At baseline, 1 month, and the end of the intervention period. Method of measurement: Non-stretchable tape measure. Hip circumference. Timepoint: At baseline, 1 month, and the end of the intervention period. Method of measurement: Non-stretchable tape measure. Body fat mass. Timepoint: At baseline, 1 month, and the end of the intervention period. Method of measurement: Body composition analyzer. Body lean mass. Timepoint: At baseline, 1 month, and the end of the intervention period. Method of measurement: Body composition analyzer. Visceral fat. Timepoint: At baseline, 1 month, and the end of the intervention period. Method of measurement: Body composition analyzer. Systolic blood pressure. Timepoint: At baseline, 1 month, and the end of the intervention period. Method of measurement: Sphygmomonometer. Diastolic blood pressure. Timepoint: At baseline, 1 month, and the end of the intervention period. Method of measurement: Sphygmomonometer. Swiss National Science Foundation Approved 2021-02-09 Ethics committe of Shahid Sadoughi University of Medical Sciences Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran Yazd Yazd Iran (Islamic Republic of)