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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03544411 |
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Date of registration:
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19/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Type 2 DM
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Scientific title:
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Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Diabetes Mellitus Type 2 |
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Date of first enrolment:
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July 2, 2018 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03544411 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Dwirini R Gunarti, DR |
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Address:
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Telephone:
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Email:
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Affiliation:
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Indonesia University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with type 2 diabetes aged 30-60 years.
- Diagnosed type 2 DM <3 years.
- Body mass index of 20-30 kg / m2
- Subjects willing to participate in research and sign informed consent.
- Drinking OHO (oral hyperglycemic medication).
Exclusion Criteria:
- There are acute and chronic complications.
- Subject is pregnant.
- Get cholesterol-lowering drugs, steroids and other drugs that affect the metabolism of
fat.
- Smoking more than 10 cigarettes / day.
- Eat regular supplements that contain phytosterols or other antioxidants that are known
by anamnesis.
- Has a disorder or gastrointestinal disease, thyroid, heart, liver, cancer, stroke and
kidney are known with medical record data.
Age minimum:
30 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lipid Disorder
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Oxidative Stress
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Diabetes Mellitus, Type 2
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Glucose, High Blood
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Intervention(s)
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Biological: bran oil
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Biological: olive oil
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Primary Outcome(s)
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Change of malondialdehyde
[Time Frame: baseline at Day0 and ,midline at Day28 and endline at Day70]
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Secondary Outcome(s)
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Change of Superoxide Dismutase
[Time Frame: baseline at Day0 and ,midline at Day28 and endline at Day70]
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Change of fasting plasma glucose
[Time Frame: baseline at Day0 and ,midline at Day28 and endline at Day70]
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Change of total cholesterol
[Time Frame: baseline at Day0 and ,midline at Day28 and endline at Day70]
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Change of High density lipoprotein
[Time Frame: baseline at Day0 and ,midline at Day28 and endline at Day70]
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Change of Trygliseride
[Time Frame: baseline at Day0 and ,midline at Day28 and endline at Day70]
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Change of Katalase
[Time Frame: baseline at Day0 and ,midline at Day28 and endline at Day70]
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Change of post prandial blood glucose
[Time Frame: baseline at Day0 and ,midline at Day28 and endline at Day70]
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Change of Glutahione
[Time Frame: baseline at Day0 and ,midline at Day28 and endline at Day70]
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Change of Low density lipoprotein
[Time Frame: baseline at Day0 and ,midline at Day28 and endline at Day70]
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Secondary ID(s)
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BeZaproject
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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