Evaluating the efficacy of two types of low-carbohydrate diets on weight, metabolic and inflammatory factors in patients with metabolic syndrome

Evaluating the efficacy of low-carbohydrate (Paleo diet) and moderate-carbohydrate diet with two delivery mode; “fixed diet plan” vs “calorie counting” on body composition, serum levels of some hepatokines and adipocytokines and flowcytometric analysis of endothelial micro particles (EMPs) in adults with metabolic syndrome: A randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016121925267N4

Enrollment

Registered

2017-07-26

Start date

2017-05-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome. Obesity due to excess calories

Interventions

Intervention 1: Intervention group 4: Receiving moderate carbohydrate diet with “fixed diet plan” for 12 weeks. Medium-carbohydrate diet is defined as a 40% carbohydrate, 30% protein and 30% fat diet.

Lifestyle

Intervention group 4: Receiving moderate carbohydrate diet with “fixed diet plan” for 12 weeks. Medium-carbohydrate diet is defined as a 40% carbohydrate, 30% protein and 30% fat diet.

Intervention group 3: Receiving moderate carbohydrate diet with calorie counting for 12 weeks. Medium-carbohydrate diet is defined as a 40% carbohydrate, 30% protein and 30% fat diet.

Intervention group 1: Receiving paleo diet with calorie counting for 12 weeks. Low-carbohydrate paleo diet is defined as a 20% carbohydrate, 35% protein and 45% fat diet.

Intervention group 2: Receiving paleo diet with “fixed diet plan” for 12 weeks. Low-carbohydrate paleo diet is defined as a 20% carbohydrate, 35% protein and 45% fat diet.

Eligibility

Sex/Gender

All

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria consists of: Age between 20 and 50 years old; Diagnosis of metabolic syndrome according to the NCEP-ATPIII criteria (If three or more of the following five criteria are met: Waist circumference over 40 inches (men) or 35 inches (women); Blood pressure over 130/85 mmHg; Fasting triglyceride (TG) level over 150 mg/dl; Fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women) and fasting blood sugar over 100 mg/dl). Exclusion criteria are: Alcohol and tobacco consumption; Pregnancy; Lactation; Menopause; History of acute or chronic liver failure; Acute or chronic gastrointestinal diseases, Cholestasis; Diabetes, Kidney disease, Seizure, Autoimmune diseases, Thyroid disorders; Using hormonal drugs such as estrogen, Hormone replacement therapy, Routine consumption of oral contraceptives, Insulin therapy; Malignancy or neoplasia; Routine consumption of antioxidants and vitamin/mineral supplements; Following vegetarian diet or any other special diet in the last 3 months.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Weight. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Scale.;Body Composition. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Body Impedence Analysis.;Serum Asprosin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Serum Chemerin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;FGF-21. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Serum CTRP1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Plasma level of Endothelial Microparticles (CD 31,105, 146). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Flowcytometry.;Appetite regulatory hormones (Peptide YY and ghrelin). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.	—

Measure

Time frame

Weight. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Scale.;Body Composition. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Body Impedence Analysis.;Serum Asprosin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Serum Chemerin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;FGF-21. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Serum CTRP1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Plasma level of Endothelial Microparticles (CD 31,105, 146). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Flowcytometry.;Appetite regulatory hormones (Peptide YY and ghrelin). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.

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Secondary

Measure	Time frame
Lipid profiles (TC, TG, LDL-C, HDL-C). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic methods for TC,TG and HDL-C For LDL-C : Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5).;Fasting blood glucose. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic colorimetric.;Fasting insulin serum. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Insulin resistance. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: HOMA-IR calculation.;Insulin sensitivity. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: QUICKI calculation.;Urine Sodium. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Electrolyte Analyzer.;Urine Potassium. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Electrolyte Analyzer.;HS-CRP. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Appetite changes. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: VAS questionnaire.;Leptin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Creatinine. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Spectrophotometer.	—

Measure

Time frame

Lipid profiles (TC, TG, LDL-C, HDL-C). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic methods for TC,TG and HDL-C For LDL-C : Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5).;Fasting blood glucose. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic colorimetric.;Fasting insulin serum. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Insulin resistance. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: HOMA-IR calculation.;Insulin sensitivity. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: QUICKI calculation.;Urine Sodium. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Electrolyte Analyzer.;Urine Potassium. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Electrolyte Analyzer.;HS-CRP. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Appetite changes. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: VAS questionnaire.;Leptin. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELISA assay.;Creatinine. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Spectrophotometer.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Maryam Mahmoudi

Tehran University of Medical Sciences

m-mahmoudi@sina.tums.ac.ir+98 21 8895 5569

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 21, 2026