on-caloric sweeteners, microbiome, and cardiometabolic risk - a randomized clinical trial of Iranian wome

Phase 3

• Conditions: women with obesity.; Overweight and obesity

• Registration Number: IRCT20130223012571N7
• Lead Sponsor: Swiss National Science Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 160

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut microbiome composition. Timepoint: At baseline and the end of intervention period. Method of measurement: Sequencing the 16s rDNA extracted from the stool samples.