Trial Outcomes & Findings for Effect of Palm Olein Intake on Lipid Profile and Appetite Regulation (NCT NCT02924896)
NCT ID: NCT02924896
Last Updated: 2025-06-22
Results Overview
blood samples will be collected at specific time points presented as minutes from consumption of mixed meal. time (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480.
COMPLETED
NA
12 participants
480 minutes
2025-06-22
Participant Flow
Crossover study design where 12 participants will consume each of the three study oils at different sequence
Participant milestones
| Measure |
Group Randomisation
Palm Olein, Soybean Oil, Interesterified Palm Olein
|
|---|---|
|
First Intervention Day 1
STARTED
|
12
|
|
First Intervention Day 1
COMPLETED
|
12
|
|
First Intervention Day 1
NOT COMPLETED
|
0
|
|
Wash Out 7 Days
STARTED
|
12
|
|
Wash Out 7 Days
COMPLETED
|
12
|
|
Wash Out 7 Days
NOT COMPLETED
|
0
|
|
Second Intervention Day 1
STARTED
|
12
|
|
Second Intervention Day 1
COMPLETED
|
12
|
|
Second Intervention Day 1
NOT COMPLETED
|
0
|
|
Third Intervention
STARTED
|
12
|
|
Third Intervention
COMPLETED
|
12
|
|
Third Intervention
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Palm Olein Intake on Lipid Profile and Appetite Regulation
Baseline characteristics by cohort
| Measure |
All Volunteers
n=12 Participants
Variables Male Female Combined n 12 Age (years) 35.7 (SD 18-60) Body Weight (kg) 66.6 (SD 11.5) BMI (kg/m2) 23.1 (SD 2.2)
% Body Fat 24.5 (SD 8.9) Systolic Blood Pressure (mmHg) 114 (SD 10.5) Diastolic Blood Pressure (mmHg) 63 (SD 6.8) Heart Rate 74 (SD8.1)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
12 participants
n=93 Participants
|
|
Age
|
35.7 years
n=93 Participants
|
|
Body Weight
|
66.6 kilograms
STANDARD_DEVIATION 11.5 • n=93 Participants
|
|
BMI
|
23.1 kg/m2
STANDARD_DEVIATION 2.2 • n=93 Participants
|
|
% Body Fat
|
24.5 percentage
STANDARD_DEVIATION 8.9 • n=93 Participants
|
|
Systolic Blood Pressure
|
114 mmHg
STANDARD_DEVIATION 10.5 • n=93 Participants
|
|
Diastolic Blood Pressure
|
63 mmHg
STANDARD_DEVIATION 6.8 • n=93 Participants
|
|
Heart Rate
|
74 bpm
STANDARD_DEVIATION 8.1 • n=93 Participants
|
PRIMARY outcome
Timeframe: 480 minutesPopulation: The AUC it is estimated across the timepoints above and across the different number of patients per arm.
blood samples will be collected at specific time points presented as minutes from consumption of mixed meal. time (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480.
Outcome measures
| Measure |
Palm Oil
n=12 Participants
Palm oil milk shake
|
Palm Ol
n=12 Participants
Interesterified Palm Olein
|
Soybean
n=12 Participants
Soybean oil: 60g of soybean oil will be given in a milkshake at breakfast
|
|---|---|---|---|
|
Change From Baseline in Appetite Hormones PYY
|
60 mmol/L*min
Standard Deviation 12.1
|
56 mmol/L*min
Standard Deviation 10.5
|
58.5 mmol/L*min
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: 480 minPopulation: The AUC it is estimated across the timepoints above and across the different number of patients per arm.
blood samples will be collected at specific time points presented as minutes from consumption of mixed meal. time (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480
Outcome measures
| Measure |
Palm Oil
n=12 Participants
Palm oil milk shake
|
Palm Ol
n=12 Participants
Interesterified Palm Olein
|
Soybean
n=12 Participants
Soybean oil: 60g of soybean oil will be given in a milkshake at breakfast
|
|---|---|---|---|
|
Change From Baseline in Glucose,
|
1545 mmol/L*min
Standard Deviation 240
|
1486 mmol/L*min
Standard Deviation 230
|
1400 mmol/L*min
Standard Deviation 250
|
SECONDARY outcome
Timeframe: ime (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480. Time Frame: 480 minutesChange From Baseline in Appetite Hormones Hide Description: blood samples will be collected at specific time points presented as minutes from consumption of mixed meal. time (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480.
Outcome measures
| Measure |
Palm Oil
n=12 Participants
Palm oil milk shake
|
Palm Ol
n=12 Participants
Interesterified Palm Olein
|
Soybean
n=12 Participants
Soybean oil: 60g of soybean oil will be given in a milkshake at breakfast
|
|---|---|---|---|
|
Change From Baseline in Appetite Hormones GLP_1
|
32 mmol/L*min
Standard Error 10
|
55 mmol/L*min
Standard Error 14.1
|
43.8 mmol/L*min
Standard Error 12.7
|
Adverse Events
Palm Olein
Interesterified Palm Olein
Soya Bean
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place