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

NCT03544411 | Completed Phase 1

• 1 other identifier: BeZaproject
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetes Mellitus, Type 2; Oxidative Stress; Glucose, High Blood; Lipid Disorder

Keywords

Olive oil; Bran oil; Type 2 Diabetes Mellitus; Antioxidant; glycemic control; lipid profile

Outcome Measures

Primary Outcomes (1)

• Change of malondialdehyde

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

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

Secondary Outcomes (9)

• Change of fasting plasma glucose

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

• Change of post prandial blood glucose

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

• Change of total cholesterol

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

• Change of Low density lipoprotein

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

• Change of High density lipoprotein

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

Study Arms (2)

Type 2 Diabetes Mellitus group 1

EXPERIMENTAL

The group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil

Biological: olive oil; Biological: bran oil

Type 2 Diabetes Mellitus group 2

EXPERIMENTAL

this group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil

Biological: olive oil; Biological: bran oil

Interventions

olive oil BIOLOGICAL

the intervention consist of 15 ml / day of olive oil

Type 2 Diabetes Mellitus group 1; Type 2 Diabetes Mellitus group 2

bran oil BIOLOGICAL

the intervention consist of 15 ml / day of bran oil

Type 2 Diabetes Mellitus group 1; Type 2 Diabetes Mellitus group 2

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead
• Fakultas Kedokteran Universitas Indonesia: collaborator

Study Sites (1)

Fkui-Kdk Kiara

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Lipid Metabolism Disorders

Interventions

Olive Oil; Rice Bran Oil

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Dwirini R Gunarti, DR

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Human Nutrition Research Centre

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2018
• First Posted: June 1, 2018
• Study Start: July 2, 2018
• Primary Completion: September 20, 2018
• Study Completion: October 5, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

ID (1)