Lipidaemia
Conditions
Keywords
palm oil, apetite regulation
Brief summary
Aims: To investigate whether acute ingestions of palm oil will have an effect on appetite regulation
Detailed description
Design: A randomized, single blind, cross over design including 4 single study visits separated by a week. Visit 1 is an acclimatization visit followed by visit 2,3, and 4 where different types of fat will be given. Population: 12 healthy males and females aged between 18 and 60 years with body mass index (BMI) between 18.5- 29.9kg/m2 and normal fasting plasma glucose and no evidence of insulin resistance will be recruited. No-pre existing morbidity including cardiac, hepatic or renal disease, history of diabetes, hypertension or hyperlipidaemia. Treatment: Acclimatization visit: At visit 1, all participants will be given a milkshake like drink containing fat, protein and carbohydrate. A cannula will be inserted for the duration of the study day but no blood will be taken. Studies show than during the first visit stress response can affect the metabolic response to the study drink resulting in inaccurate results. Study visit 2,3,4: following the acclimatization visit, participants will attend 3 more study visits separated by a week to test the metabolic response to the following fats: palm olein, interesterified palm olein and soybean oil in random order. Participants will be asked to complete a visual analogue scale questionnaire about their appetite at each time point. Fasting and postprandial plasma glucose, insulin, appetite hormones and lipids will be measured.
Interventions
DIETARY_SUPPLEMENTPalm olein
60g of palm olein will be given in a milkshake at breakfast
DIETARY_SUPPLEMENTInteresterified palm olein
60g of interesterified palm olein will be given in a milkshake at breakfast
DIETARY_SUPPLEMENTSoybean oil
60g of soybean oil will be given in a milkshake at breakfast
Sponsors
Malaysia Palm Oil Board
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
Number of participants 12
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy and overweight male and female volunteers of all ethnicities (body mass index (BMI) of 18.5-29.9 kg/m2) * Age between 18-60 years (inclusive)
Exclusion criteria
* Abnormal liver function test (elevated alanine aminotransferase and aspartate transaminase)/ abnormal kidney function test (elevated plasma creatinine) * History of type 2 diabetes mellitus, cancer, stomach ulcers, drug abuse or alcoholism, gastrointestinal disorders like Crohn's disease * Smokers * On lipid/blood pressure- lowering medication/supplements * Blood pressure\>140/90 mm Hg * Fasting total cholesterol \> 6.2 mmol/L * Fasting triacylglyceride \> 2.0 mmol/L * Subject must not be allergic to intervention * Pregnancy and breastfeeding (pregnancy test will be undertaken at the screening visit) * Subjects taking nutritional supplements or on any weight-loss programs * Subjects who gained or lost ≥ 3kg weight in the past three months * Subjects with history of hypo- and hyperthyroidism * Subjects who are anaemic and those who donated blood within three months of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Appetite Hormones PYY | 480 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glucose, | 480 min | 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 |
| Change From Baseline in Appetite Hormones GLP_1 | ime (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480. Time Frame: 480 minutes | Change 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Crossover study design where 12 participants will consume each of the three study oils at different sequence
Participants by arm
| Arm | Count |
|---|---|
| All Volunteers 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) | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Volunteers |
|---|---|
| Age | 35.7 years |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| BMI | 23.1 kg/m2 STANDARD_DEVIATION 2.2 |
| % Body Fat | 24.5 percentage STANDARD_DEVIATION 8.9 |
| Body Weight | 66.6 kilograms STANDARD_DEVIATION 11.5 |
| Diastolic Blood Pressure | 63 mmHg STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Heart Rate | 74 bpm STANDARD_DEVIATION 8.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United Kingdom | 12 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
| Systolic Blood Pressure | 114 mmHg STANDARD_DEVIATION 10.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Change From Baseline in Appetite Hormones PYY
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.
Time frame: 480 minutes
Population: The AUC it is estimated across the timepoints above and across the different number of patients per arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Soybean | Change From Baseline in Appetite Hormones PYY | 58.5 mmol/L*min | Standard Deviation 11.3 |
| Palm Oil | Change From Baseline in Appetite Hormones PYY | 60 mmol/L*min | Standard Deviation 12.1 |
| Interesterified Palm Olein | Change From Baseline in Appetite Hormones PYY | 56 mmol/L*min | Standard Deviation 10.5 |
Secondary
Change From Baseline in Appetite Hormones GLP_1
Change 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.
Time frame: ime (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480. Time Frame: 480 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Soybean | Change From Baseline in Appetite Hormones GLP_1 | 43.8 mmol/L*min | Standard Error 12.7 |
| Palm Oil | Change From Baseline in Appetite Hormones GLP_1 | 32 mmol/L*min | Standard Error 10 |
| Interesterified Palm Olein | Change From Baseline in Appetite Hormones GLP_1 | 55 mmol/L*min | Standard Error 14.1 |
Secondary
Change From Baseline in Glucose,
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
Time frame: 480 min
Population: The AUC it is estimated across the timepoints above and across the different number of patients per arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Soybean | Change From Baseline in Glucose, | 1400 mmol/L*min | Standard Deviation 250 |
| Palm Oil | Change From Baseline in Glucose, | 1545 mmol/L*min | Standard Deviation 240 |
| Interesterified Palm Olein | Change From Baseline in Glucose, | 1486 mmol/L*min | Standard Deviation 230 |