AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 1NCT03544411

Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Type 2 DM

A Phase 1 study testing olive oil and bran oil in people with Diabetes Mellitus, Type 2 and Oxidative Stress, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study determines the effect of olive oil and bran oil on antioxidant levels, and glycemic control in patients with type 2 diabetes mellitus (DM) Intervention: Patient type 2 DM will receive olive oil and bran oil with cross over study Read more about this study

Who is it for?
Ages 30 to 60 years
What is being tested?
olive oil and bran oil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteIndonesia
Study dates
2 Jul 2018to 5 Oct 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Fkui-Kdk Kiara

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

Official title: Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Diabetes Mellitus Type 2

This study determines the effect of olive oil and bran oil on antioxidant levels, and glycemic control in patients with type 2 diabetes mellitus (DM)

Intervention: Patient type 2 DM will receive olive oil and bran oil with cross over study

Read the detailed description

Diabetes mellitus (DM) has become one of the global public health problems. The chronic complications of type 2 DM can be macrovascular and microvascular complications that can decrease the quality of life of the patient. The main goal of sustainable DM nutrition therapy is to keep glucose in the blood close to normal levels to stop hyperglycemic and hyperlipidemic events that may inhibit further complications

This study was a clinical trial with cross over study design, random allocation, and double blindness to compare changes in antioxidant, glucose, cholesterol and triglyceride levels supplemented with 15 ml / day of olive oil (KZ) with supplementation of 15 ml / day of bran oil (KB). Provision of oil for 4 weeks in a row. During the 2-week interval not being treated (wash out). After the wash out period cross-over by exchanging olive oil supplementation to rice bran and vice versa for 4 consecutive weeks. The research will be conducted at Family Clinic Clinic FKUI Kayu Putih, Jakarta.

Being tested
olive oil, bran oil
Keywords
Olive oil, Bran oil, Type 2 Diabetes Mellitus, Antioxidant, glycemic control, lipid profile
Medical subject headings
Diabetes Mellitus, Type 2, Lipid Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • olive oilBiological

    the intervention consist of 15 ml / day of olive oil

  • bran oilBiological

    the intervention consist of 15 ml / day of bran oil

Study groups in NCT03544411
Study groupRoleWhat they receive
Type 2 Diabetes Mellitus group 1ExperimentalThe group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil
Receives: Biological: olive oil; Biological: bran oil
Type 2 Diabetes Mellitus group 2Experimentalthis group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil
Receives: Biological: olive oil; Biological: bran oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of malondialdehyde

    Change from baseline malondialdehyde at 4 weeks and at 10 weeks, is measured in pmol/mL

    Measured: baseline at Day0 and ,midline at Day28 and endline at Day70

Secondary outcomes (9)

  1. Change of fasting plasma glucose

    Change from baseline fasting plasma glucose at 4 weeks and at 10 weeks, is measured in mg/dL

    Measured: baseline at Day0 and ,midline at Day28 and endline at Day70

  2. Change of post prandial blood glucose

    Change from baseline post prandial blood glucose at 4 weeks and at 10 weeks, is measured in mg/dL

    Measured: baseline at Day0 and ,midline at Day28 and endline at Day70

  3. Change of total cholesterol

    Change from baseline cholesterol at 4 weeks and at 10 weeks, is measured in mg/dL

    Measured: baseline at Day0 and ,midline at Day28 and endline at Day70

  4. Change of Low density lipoprotein

    Change from baseline Low density lipoprotein at 4 weeks and at 10 weeks, is measured in mg/dL

    Measured: baseline at Day0 and ,midline at Day28 and endline at Day70

  5. Change of High density lipoprotein

    Change from baseline High density lipoprotein at 4 weeks and at 10 weeks, is measured in mg/dL

    Measured: baseline at Day0 and ,midline at Day28 and endline at Day70

  6. Change of Trygliseride

    Change from baseline trygliseride at 4 weeks and at 10 weeks, is measured in mg/dL

    Measured: baseline at Day0 and ,midline at Day28 and endline at Day70

  7. Change of Katalase

    Change from baseline katalase at 4 weeks and at 10 weeks, is measured in unit/ mg protein

    Measured: baseline at Day0 and ,midline at Day28 and endline at Day70

  8. Change of Superoxide Dismutase

    Change from baseline superoxide dismutase at 4 weeks and at 10 weeks, is measured in unit/ mg protein

    Measured: baseline at Day0 and ,midline at Day28 and endline at Day70

  9. Change of Glutahione

    Change from baseline gluthatione at 4 weeks and at 10 weeks, is measured in nmol/ gram

    Measured: baseline at Day0 and ,midline at Day28 and endline at Day70

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2018
  2. Study start2 Jul 2018
  3. Primary completion20 Sep 2018
  4. Study completion5 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
This study was a clinical trial with cross over study design, random allocation, and double blindness to compare changes in antioxidant, glucose, cholesterol and triglyceride levels supplemented with 15 ml / day of olive oil (KZ) with supplementation of 15 ml / day of bran oil (KB). Provision of oil for 4 weeks in a row. During the 2-week interval not being treated (wash out). After the wash out period cross-over by exchanging olive oil supplementation to rice bran and vice versa for 4 consecutive weeks.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03544411
Sponsor's protocol ID
BeZaproject
Status last verified
Oct 2018
First submitted
19 May 2018
Last updated
16 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing olive oil and bran oil in people with Diabetes Mellitus, Type 2 and Oxidative Stress, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of malondialdehyde (time frame: baseline at Day0 and ,midline at Day28 and endline at Day70). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03544411.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in