NCT02245113

Brief Summary

This study will be comparing human body responses by the effects of diets cooked with NoveLin, virgin olive oil and RBD coconut oil.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

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

December 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

6 months

First QC Date

September 17, 2014

Last Update Submit

September 18, 2014

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

  • change in c-peptide level

    week 0(baseline) and week 6

Secondary Outcomes (5)

  • change in insulin resistance's markers

    week 0(baseline) and week 6

  • change in inflammatory markers

    week 0(baseline) and week 6

  • change in obesity markers

    week 0(baseline) and week 6

  • change in lipid profile

    week 0(baseline) and week 6

  • change in physical characteristic (eg. BMI, body weight)

    week 0(baseline) and week 6

Study Arms (3)

Test Fat P

EXPERIMENTAL

Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3.

Other: diets

Test Fat Q

EXPERIMENTAL

Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3.

Other: diets

Test Fat R

EXPERIMENTAL

Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3.

Other: diets

Interventions

dietsOTHER

Feeding trial for 6 weeks (week 0 - baseline). The experimental diets are comprised of 30% kcal fat, 15% kcal protein and 55% kcal carbohydrate. Each of the test fat contributes to two-thirds of total dietary fat will be compared.

Test Fat PTest Fat QTest Fat R

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • males and females aged 20-60 years
  • BMI 23 - 27.5 kg/m2
  • free from any disease
  • not on any medication or treatment associated with reduction of CVD
  • non-smokers and non-heavy drinker or having smoking or alcoholic history
  • not pregnant or lactating
  • willing and able to comply

You may not qualify if:

  • people on weight reduction therapy/program
  • people on cholesterol reduction medicatio
  • have one or more of the chronic diseases
  • people with blood clotting problem/ coagulopathy / deep vein thrombosis.
  • hypertensive persons (systolic pressure \> 140 mmHg, diastolic pressure \> 90 mmHg)
  • female who is pregnant
  • people travel to overseas during feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MPOB

Kajang, Selangor, 43000, Malaysia

Location

MeSH Terms

Conditions

Overweight

Interventions

Diet

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Voon Phooi Tee, PhD

    MPOB

    PRINCIPAL INVESTIGATOR

  • Lee Sin Tien, BSc

    UPM

    PRINCIPAL INVESTIGATOR

  • Norhaizan Md Esa, PhD

    UPM

    PRINCIPAL INVESTIGATOR

  • Tony Ng Kock Wai, PhD

    IMU

    PRINCIPAL INVESTIGATOR

  • Verna Lee Kar Mun, PhD

    IMU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 19, 2014

Study Start

December 1, 2013

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations

MY(1)