Protocol summary
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Study aim
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Determining the effect of theobromine supplementation on anthropometric indices, glycemic indices, cardiovascular risk factors, and genes expression of PPARα and Sirt1 in subjects with metabolic syndrome.
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Design
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A 12-week triple-blid, randomized parallel clinical trial on 80 overweight and obese subjects with metabolic syndrome
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Settings and conduct
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After the approval of the proposal study subjects were selected from those who refer to the health centers affiliated to Kermanshah University of Medical Sciences. Eligible individuals will be interviewed and the goals, methods and importance of conducting the study will be explained in detail to each of them After providing written consent, they will be divided into 2 groups of Theobromine and placebo by Stratified Blocked Randomization. Subjects will be asked to take a 450 mg / day theobromine capsule for 12 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Overweight or subjects aged 40 to 55 years with metabolic syndrome.
Exclusion criteria: having Diabetes, cancer, hepatitis, cardiovascular disease, hematological, neurological, renal, thyroid and gastrointestinal disorders. Consumption of medications or supplements that affect appetite, weight or metabolism, and having any weight loss diet or heavy exercise program in the past 6 months. Patients treated with statins and antihypertensive drugs will only be included in the study if they are treated for more than 3 months for statins and more than 6 months for high blood pressure.
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Intervention groups
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Intervention group: 450 mg/d theobromine capsule in breakfast meal for 12 weeks.
Control group: 450 mg/d placebo capsule in breakfast meal for 12 weeks.
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Main outcome variables
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weight, waist circumference, hip circumference, fasting blood sugar, fasting insulin, HOMA-IR, lipid profile, HDL2-c, HDL3-c, HDL2-c/HDL3-c, and blood pressure.
General information
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Reason for update
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Considering the association of HDL-c subclasses (HDL2-c, HDL3-c and HDL2-c/HDL3-c) with metabolic syndrome and cardiovascular diseases (CVD), assessing these variables can provide a more precise result on the effect of theobromine on CVD risk factors. Additionally, HDL-c function can be determined via assessing these factors. Therefore, we aim to include these variables in our study.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20091114002709N59
Registration date:
2022-03-05, 1400/12/14
Registration timing:
registered_while_recruiting
Last update:
2023-12-12, 1402/09/21
Update count:
1
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Registration date
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2022-03-05, 1400/12/14
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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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2022-01-19, 1400/10/29
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Expected recruitment end date
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2022-05-19, 1401/02/29
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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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The effect of theobromine supplementation on anthropometric indices, glycemic indices, cardiovascular risk factors, and genes expression of PPARα and Sirt1 in subjects with metabolic syndrome.
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Public title
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The effect of Theobromine supplementation on anthropometric indices, glycemic indices, cardiovascular risk factors, and genes expression of PPARα and Sirt1 in subjects with metabolic syndrome.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Overweight or obese (25 ≤BMI≤ 35 kg/m^2) men and women aged 40 to 55 years .
Having metabolic syndrome according to IDF definition ( Waist circumference greater than 94 cm for men and 80 cm for women, Triglyceride ≥ 150mg/dl, HDL-c ≤ 40mg/dl for men and HDL-c ≤ 50mg/dl for women or medication, Systolic blood pressure ≥ 130mmHg and DBP≥ 85 mmHg or medication, Fasting blood sugar≥ 100mg/dl or medication)
Tendency to participate in the study
Exclusion criteria:
Smoking
Subjects with diabetes, cancer, hepatitis, cardiovascular diseases, hematological disorders, Neurological disorders, renal disorders, gastrointestinal and thyroid disorders
Insulin therapy, use hypoglycemic and weight reduction medication, vasodilators, hormone therapy, corticosteroids, non steroid anti inflammatory drugs, antihistamines, Selective serotonin reuptake inhibitors, anti gout and psychotics medication.
Use of any vitamin and mineral supplement, antioxidants and omega3.
Pregnancy, lactation and adherence to a specific diet
People treated with statins and antihypertensive drugs will only be included in the study if they are treated for more than 3 months for statins and more than 6 months for high blood pressure.
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Age
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From 40 years old to 55 years old
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Gender
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Both
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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:
80
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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 done by Stratified Blocked Randomization with the volume 4. Stratification will be done based on participants BMI (25-30 and 30-35). Considering the sample size of 40 in each strata, 10 blocks with volume 4 will be produced in each strata and subjects in each strata will be assigned to treatment or placebo group based on a random list produced by PASS 11 statistical software . The random list containing 3-digit codes for each patient that identifies the relevant treatment will be provided to the researcher and will be inserted on the labels of 80 drug bottles. Only the study project executive expert is aware of the designed codes. Randomization and blinding of the study are performed to maintain concealment.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Researchers, participants and data analyzer will be blinded in this study. so that the patient does not know which treatment group he or she belongs to, because both the placebo and supplement groups are prepared in exactly the same form and package. By following a random list containing codes 1 to 80, The researchers also do not know which treatment group was assigned to each patient. Because the random list will be prepared by the project executive expert (Personal except researcher and data analyst) and only the patient code will be recorded on each drug package. Thus, none of the participants, researchers and data analysts of the study type They do not know the dedicated treatment and the study will be triple-blind.
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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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2021-11-20, 1400/08/29
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Ethics committee reference number
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IR.IUMS.REC.1400.761
Health conditions studied
1
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Description of health condition studied
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Metabolic syndrome
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Weight
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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Seca scale
2
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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 of the study and at the end of week 12
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Method of measurement
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Weight (kg) divided by height squared (square meters)
3
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Description
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Waist circumference
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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Measuring tape
4
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Description
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Hip circumference
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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Measuring tape
5
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Description
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Systolic blood pressure
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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Sphygmomanometer
6
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Description
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Triglyceride
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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Colorimetri
7
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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Colorimetri
8
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Description
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LDL-c
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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Colorimetri
9
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Description
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HDL-c
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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Colorimetri
10
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Description
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Fasting insulin
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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ELIZA kit
11
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Description
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Fasting blood sugar
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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Enzymatic
12
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Description
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HDL2-C Subclass
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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ELISA (enzyme-linked immunosorbent assay)
13
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Description
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HDL3-C Subclass
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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ELISA (enzyme-linked immunosorbent assay)
14
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Description
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HDL2-C/HDL3-C
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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Dividing HDL2-C to HDL3-C values
Secondary outcomes
1
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Description
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Sirtuin 1 gene expression
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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Real Time PCR
2
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Description
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PPARα gene expression
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Timepoint
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At the beginning of the study and at the end of week 12
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Method of measurement
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Real Time PCR
Intervention groups
1
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Description
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Intervention group: Daily intake of a 450 mg theobromine capsule (made by BulkSupplement company; USA) in breakfast meal for 12 weeks.
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Category
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Treatment - Other
2
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Description
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Control group: Daily intake of a 450 mg maltodextrin capsule (made by Karen Pharmaceuticals and Dietary Supplements Company; Iran) in breakfast meal for 12 weeks.
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Category
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Placebo
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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Iran 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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اطلاعات بیشتری وجود ندارد
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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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information on the main implications can be shared at the end of the study.
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When the data will become available and for how long
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The access period will be 6 months after the results are published.
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To whom data/document is available
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The data from this study will be available only to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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6 months after the publication of the articles obtained from the data of this project, at the request of the person in charge of the project and his consent, the study data can be made available to researchers.
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From where data/document is obtainable
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Applicants can contact the responsible author via email or the following mailing address to obtain the required data. Postal address: Tehran-Hemmat Highway-Iran University of Medical Sciences-Faculty of Health-Department of Nutrition. Contact number: 00982188622755. Email: shidfar.f@iums.ac.ir
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What processes are involved for a request to access data/document
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Applicants will be able to access the study data by sending an email to the responsible author within a maximum of one week.
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Comments
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