NCT01428960

Brief Summary

To determine the effect of degree of fat saturation on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety perceptions, and insulinemic responses in healthy adult subjects. Study hypothesis: The degree of fat saturation does not affect postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, insulinemic or satiety responses in health adult subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2011

Typical duration for not_applicable healthy

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

June 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

October 31, 2013

Status Verified

October 1, 2012

Enrollment Period

1.5 years

First QC Date

August 26, 2011

Last Update Submit

October 30, 2013

Conditions

Healthy

Keywords

Palm mid fractionShea buttersn-1, sn-3 fatty acidsCholesterolPostprandial lipemia,Inflammatory markersSatietyGut hormoneInsulin

Outcome Measures

Primary Outcomes (1)

  • glucose-dependent insulintropic polypeptide (GIP)

    4 hours

Secondary Outcomes (3)

  • Lipid profile

    4 hours

  • Inflammatory markers

    4 hours

  • Haemostatic indices

    4 hours

Study Arms (3)

Palm Mid Fraction

EXPERIMENTAL
Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil

Shea Butter

EXPERIMENTAL
Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil

High Oleic Sunflower Oil

EXPERIMENTAL
Dietary Supplement: Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil

Interventions

Palm Mid Fraction, Shea Butter, High Oleic Sunflower OilDIETARY_SUPPLEMENT

Acute effect of sn-1 and sn-3 palmitic acid-rich or stearic acid-rich fats on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety, and insulinemic response in human volunteers ; 6 wk each with 2 week wash out in between

Also known as: POP vs SOS vs OOO
High Oleic Sunflower OilPalm Mid FractionShea Butter

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult male or female staff, aged between 25-50 years
  • BMI 18.5 - 25.0 kg/m2
  • Blood pressure: Systolic: \<140 mmHg, diastolic: \<90 mmHg
  • c. Normolipidemic (Total cholesterol \<6.2 mM/L (\<240 mg/dL), Fasting TG \<1.70 mM/L (\<150 mg/dL) d. Fasting glucose 4.0- 7.0 mM/L

You may not qualify if:

  • Smokers
  • On cholesterol or blood glucose medication
  • Substance abuse (eg. alcohol, cigarette smoking)
  • For women, pregnant or lactating
  • Going overseas during period of study
  • Blood clotting problem
  • Public transportation to work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaysian Palm Oil Board Kajang, Selangor,

Kajang, Selangor, 43000, Malaysia

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Tony Ng

    IMU University, Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2011

First Posted

September 5, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Study Completion

May 1, 2013

Last Updated

October 31, 2013

Record last verified: 2012-10

Locations

MY(1)