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Effect of Concomitant Synbiotic and L-Carnitine Supplementation in Obese Women

Effect of Concomitant Synbiotic and L-Carnitine Supplementation on Nutritional Status, Metabolic, Oxidative, Inflammatory Indices and Plasma Levels of Trimethylamine Oxide (TMAO) in Obese Women

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20080904001197N13
Enrollment
90
Registered
2018-01-19
Start date
2018-01-21
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

Obesity. Overweight and obesity

Interventions

Intervention 1: Intervention group 1: Oral administration of 1000 mg/day L-carnitine as two 500 mg tablets (Karen pharmaceutical and nutritional supplements company) taken with lunch & dinner, and one
Treatment - Other
Intervention group 1: Oral administration of 1000 mg/day L-carnitine as two 500 mg tablets (Karen pharmaceutical and nutritional supplements company) taken with lunch & dinner, and one 250 mg synbioti
Intervention group 2: Oral administration of 1000 mg/day L-carnitine as two 500 mg tablets (Karen pharmaceutical and nutritional supplements company) taken with lunch & dinner, and one synbiotic place

Sponsors

Nutrition Research Center, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
19 Years to 49 Years

Inclusion criteria

Inclusion criteria: Female Age: 19-49 years Body Mass Index between 30 to 35 kg/m2 Patient tendency to participate in the study

Exclusion criteria

Exclusion criteria: Pregnancy Lactation Menopause Cardiovascular diseases, kidney, lung, gastrointestinal, infectious, diabetes or thyroid disorders History of recent surgeries or any intestine surgeries Taking any Antibiotics during or 2 months before entering the study Taking Probiotic, Prebiotic or Synbiotic supplements during or 2 months before entering the study Taking Fish oil or any weight loss supplements during or 2 months before entering the study Vegetarians Smoking or Alcohol Consumption Following weight loss diets during or 2 months before entering the study Taking Steroid, Immunosuppressive or Anticonvulsant drugs

Design outcomes

Primary

MeasureTime frame
Body Mass Index (BMI). Timepoint: At the beginning, after 4 weeks and at the end of the intervention (after 8 weeks). Method of measurement: BMI= weight(kg)/height^2(m^2).;Dietary intake. Timepoint: At the beginning, after 4 weeks and at the end of the intervention (after 8 weeks). Method of measurement: 24 hours food recall questionnaire.;Plasma Trimethylamine Oxide (TMAO) level. Timepoint: At the beginning & end of the intervention (8 weeks). Method of measurement: LC/MS/MS: Liquid Chromatography–Mass Spectrometry.

Secondary

MeasureTime frame
Oxidative factors:Total Antioxidant Capacity (TAC). Timepoint: At the beginning & end of the intervention (8 weeks). Method of measurement: kit/ Spectrophotometry.;Oxidative factors: Malondialdehide (MDA). Timepoint: At the beginning & end of the intervention (8 weeks). Method of measurement: Thio Barbituric Acid (TBA), Fluorimetric method.;Inflammatory factors: hs-CRP. Timepoint: At the beginning & end of the intervention (8 weeks). Method of measurement: Immunoturbidimetry method.;Inflammatory factors: IL-6. Timepoint: At the beginning & end of the intervention (8 weeks). Method of measurement: Enzyme-linked Immunosorbent Assay (ELISA) kit.;Inflammatory factors: TNF-a. Timepoint: At the beginning & end of the intervention (8 weeks). Method of measurement: Enzyme-linked Immunosorbent Assay (ELISA) kit.;Inflammatory factors: Lipopolysaccharide (LPS). Timepoint: At the beginning & end of the intervention (8 weeks). Method of measurement: Enzyme-linked Immunosorbent Assay (ELISA) kit.;Anti Inflammatory factor: IL-10. Timepoint: At the beginning & end of the intervention (8 weeks). Method of measurement: Enzyme-linked Immunosorbent Assay (ELISA) kit.;Insulin resistance indices: Glucose. Timepoint: At the beginning & end of the intervention (8 weeks). Method of measurement: Spectrophotometry.;Insulin resistance indices: Insulin. Timepoint: At the beginning & end of the intervention (8 weeks). Method of measurement: Enzyme-linked Immunosorbent Assay (ELISA).;Insulin resistance indices: Homeostatic Model Assessment (HOMA) of Insulin Resistance (HOMA-IR). Timepoint: At the beginning & end of the intervention (8 weeks). Method of measurement: Formula calculation.;Lipid Profile: Triglyceride (TG). Timepoint: At the beginning & end of the intervention (8 weeks). Method of measurement: kit/ Spectrophotometry.;Lipid Profile: Total cholesterol (TC). Timepoint: At the beginning & end of the intervention (8 weeks). Method of measurement: kit/ Spectrophotometry.;Lipid Profile: HDL-

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarnoush Fallah

Nutrition Research Center, Tabriz University of Medical Sciences

fallahfarnoush@gmail.com+98 41 3335 2295

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 8, 2026