The effect of moderately-restricted carbohydrate diet on intestinal microbiota

Not Applicable

• Conditions: Metabolic syndrome.; Metabolic syndrome; E88.81

• Registration Number: IRCT20210307050621N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

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

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

Having metabolic syndrome based on The Adult Treatment Panel guidelines (ATP III) index
Age 20 to 50 years
Not being menopausal
Body mass index greater than or equal to 25
Willingness to participate in the study

Exclusion Criteria

Pregnancy or breastfeeding or deciding to get pregnant shortly
Smoking even one cigarette or once using other tobacco such as hookah in the past week or repeated drug use
History of the liver, kidney, thyroid, gastrointestinal diseases, diabetes, rheumatoid arthritis, lupus, severe infection, and trauma
History of weight loss surgery
Having a serious allergy to a particular medicine or food
Follow a special diet for 3 months before the study
Take any amount of supplements or food products fortified with fins or probiotics during the last 3 months
Taking a variety of antibiotics per dose during the 3 months before enrollment
Taking drugs that affect weight, appetite, blood pressure, or metabolism of carbohydrates and fats in the last 3 months

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intestinal microbiome composition. Timepoint: Before the intervention and 3 months later. Method of measurement: Polymerase Chain Reaction (PCR) method.;Lipid profile (serum triglyceride, total serum cholesterol, low-density lipoprotein, high-density lipoprotein). Timepoint: Before the intervention and 3 months later. Method of measurement: Enzymatic method.;Waist circumference. Timepoint: Before the intervention and 3 months later. Method of measurement: Tape meter.;Fasting blood sugar. Timepoint: Before the intervention and 3 months later. Method of measurement: By glucose oxidase method and using commercial kits.

Secondary Outcome Measures

Name	Time	Method
Body weight. Timepoint: Before the intervention and 3 months later. Method of measurement: Scale.;Blood pressure. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Sphygmomanometer.;Height. Timepoint: Before the intervention and 3 months later. Method of measurement: Meter.