Protocol summary
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Study aim
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Effect of Concomitant Synbiotic and L-Carnitine Supplementation on Nutritional Status, Metabolic, Oxidative and Inflammatory Indices and Plasma Levels of Trimethylamine Oxide (TMAO) in Obese Women
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Design
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In this double blind randomized clinical trial, 90 obese volunteer eligible women will be recruited by simple sampling method through public announcement and randomly allocated into two intervention groups; informed consent will be obtained from each participant.
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Settings and conduct
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Allocation to groups will be blinded for the researcher and participants.Study will be conducted at Nutrition Research Center, Tabriz University of Medical Sciences. Sampling will be done through public announcement.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Female volunteers, age: 19-49 years & Body Mass Index between 30 to 35 kg/m2. Exclusion criteria: diabetes, cardiovascular, gastrointestinal, thyroid, infectious and ... disorders. Taking any antibiotics, probiotic or synbiotics or following weight loss diets during or 2 months before entering the study; taking steroid, immunosuppressive or anticonvulsant drugs.
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Intervention groups
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Intervention group 1:1000 mg/day L-carnitine as two 500 mg tablets and one 250 mg synbiotic capsule; Intervention group 2: 1000 mg/day L-carnitine as two 500 mg tablets and synbiotic placebo; for 8 weeks
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Main outcome variables
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Nutritional status (Dietary intake & Anthropometric indices); Metabolic (Lipid profile, Glucose, Insulin, HOMA-IR); Oxidative (Total Antioxidant Capacity(TAC) & Malondialdehyde(MDA); Inflammatory (hs-CRP, IL-6, TNF-α, LPS); Anti inflammatory (IL-10) Indices and plasma Trimethylamine Oxide (TMAO) levels
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20080904001197N13
Registration date:
2018-01-19, 1396/10/29
Registration timing:
prospective
Last update:
2018-01-19, 1396/10/29
Update count:
2
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Registration date
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2018-01-19, 1396/10/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-01-21, 1396/11/01
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Expected recruitment end date
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2019-01-21, 1397/11/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effect of Concomitant Synbiotic and L-Carnitine Supplementation in Obese Women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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:
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
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Age
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From 19 years old to 49 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is performed by permuted block randomization (block size:4 or 8) using RAS software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This is a double blind study in which the researcher and patients will be blinded to the group assignments. The patients will receive the supplements by another person who is not involved in performing the assessment and chemical analysis. Patients will be informed of two study groups, however group assignments will be blinded.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-12-04, 1396/09/13
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Ethics committee reference number
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IR.TBZMED.REC.1396.747
Health conditions studied
1
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Description of health condition studied
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Obesity
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ICD-10 code
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E66
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ICD-10 code description
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Overweight and obesity
Primary outcomes
1
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Description
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Body Mass Index (BMI)
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Timepoint
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At the beginning, after 4 weeks and at the end of the intervention (after 8 weeks)
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Method of measurement
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BMI= weight(kg)/height^2(m^2)
2
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Description
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Dietary intake
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Timepoint
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At the beginning, after 4 weeks and at the end of the intervention (after 8 weeks)
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Method of measurement
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24 hours food recall questionnaire
3
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Description
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Plasma Trimethylamine Oxide (TMAO) level
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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LC/MS/MS: Liquid Chromatography–Mass Spectrometry
Secondary outcomes
1
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Description
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Oxidative factors:Total Antioxidant Capacity (TAC)
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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kit/ Spectrophotometry
2
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Description
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Oxidative factors: Malondialdehide (MDA)
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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Thio Barbituric Acid (TBA), Fluorimetric method
3
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Description
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Inflammatory factors: hs-CRP
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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Immunoturbidimetry method
4
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Description
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Inflammatory factors: IL-6
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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Enzyme-linked Immunosorbent Assay (ELISA) kit
5
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Description
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Inflammatory factors: TNF-α
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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Enzyme-linked Immunosorbent Assay (ELISA) kit
6
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Description
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Inflammatory factors: Lipopolysaccharide (LPS)
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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Enzyme-linked Immunosorbent Assay (ELISA) kit
7
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Description
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Anti Inflammatory factor: IL-10
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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Enzyme-linked Immunosorbent Assay (ELISA) kit
8
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Description
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Insulin resistance indices: Glucose
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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Spectrophotometry
9
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Description
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Insulin resistance indices: Insulin
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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Enzyme-linked Immunosorbent Assay (ELISA)
10
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Description
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Insulin resistance indices: Homeostatic Model Assessment (HOMA) of Insulin Resistance (HOMA-IR)
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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Formula calculation
11
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Description
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Lipid Profile: Triglyceride (TG)
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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kit/ Spectrophotometry
12
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Description
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Lipid Profile: Total cholesterol (TC)
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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kit/ Spectrophotometry
13
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Description
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Lipid Profile: HDL-c
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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kit/ Spectrophotometry
14
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Description
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Lipid Profile: LDL-c
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Timepoint
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At the beginning & end of the intervention (8 weeks)
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Method of measurement
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Formula calculation
Intervention groups
1
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Description
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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 synbiotic capsule, Cfu: 1x108 (Protexin, UK), for 8 weeks
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Category
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Treatment - Other
2
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Description
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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 placebo capsule, (maltodextrin), for 8 weeks
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Nutrition Research Center, Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Study Protocol, Statistical Analysis Plan, Informed Consent Form & Clinical Study Report will be shared.
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When the data will become available and for how long
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Starting 3 months after publication; no end date.
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To whom data/document is available
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Researchers working in academic institutions
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Under which criteria data/document could be used
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Published analyzed data will be shared.
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From where data/document is obtainable
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Responsible person: Farnoush Fallah;
email: fallahfarnoush@gmail.com
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What processes are involved for a request to access data/document
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Documents will be shared in 10 working days after receiving the written application by email.
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Comments
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