NCT00715312

Brief Summary

Rationale: The effect of positional distribution of dietary fatty acids on markers of inflammation and blood lipids metabolites on diets containing fatty acids such as oleic acid that are associated with reduced risk of cardiovascular disease is not widely studied. Hypothesis: There would be difference detected in the concentrations of markers of inflammation and blood lipid metabolites in human volunteers fed controlled diets. Study design: A randomized, double-blind, crossover clinical trial that involves 41 healthy volunteers. The volunteers will be selected based on inclusion and exclusion criteria. They will consume controlled diets for 5 weeks that provides 15% of energy from protein, 30% of energy from fat, and 55% of energy from carbohydrates. Volunteers will be assigned to each test diets which is cooked with novel olein, palm stearin or partially hydrogenated soybean oil in random order until all three diets has consumed by each person. Main study parameters: LDL-cholesterol

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
Last Updated

July 15, 2008

Status Verified

July 1, 2008

Enrollment Period

4 months

First QC Date

July 11, 2008

Last Update Submit

July 14, 2008

Conditions

Inflammation

Keywords

InflammationLDLOleic acidPalmitic acidtrans fatty acidC-reactive protein

Outcome Measures

Primary Outcomes (1)

  • LDL-cholesterol

    5 weeks

Secondary Outcomes (1)

  • C-reactive protein

    5 weeks

Study Arms (1)

A

EXPERIMENTAL
Other: Novel Olein

Interventions

Novel OleinOTHER

A total of 70g of test oil is incorporated into cooked meal which accounts for 30-35% of calorie intake

A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy and free from any disease and absence of family history for arteriosclerosis or hypertension
  • Not on any medication or supplements or weight loss program
  • Non smokers and alcoholics

You may not qualify if:

  • Having some health-related problems e.g fever, flu, allergy, chronic diseases
  • On some treatment or medication
  • Smokers and alcoholics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaysia Palm Oil Board

Kajang, Selangor, 50720, Malaysia

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Teng Kim Tiu

    Malaysia Palm Oil Board

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 11, 2008

First Posted

July 15, 2008

Study Start

February 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

July 15, 2008

Record last verified: 2008-07

Locations

MY(1)