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| Name | Class |
|---|---|
| Malaysia Palm Oil Board | OTHER_GOV |
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Aims: To investigate whether acute ingestions of palm oil will have an effect on appetite regulation
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other | Palm Olein |
|
| Arm 2 | Other | Soybean Oil |
|
| Arm 3 | Other | Interesterified Palm Olein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palm olein | Dietary Supplement | 60g of palm olein will be given in a milkshake at breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 480 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 480 min |
| Change From Baseline in Appetite Hormones GLP_1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Frost | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIHR/Wellcome Trust Imperial Clinical Research Facility | London | W12 0HS | United Kingdom |
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| Label | URL |
|---|---|
| Clinical Research Facility official web page | View source |
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Crossover study design where 12 participants will consume each of the three study oils at different sequence
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| ID | Title | Description |
|---|---|---|
| FG000 | Group Randomisation | Palm Olein, Soybean Oil, Interesterified Palm Olein |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Day 1 |
| |||||||||||||
| Wash Out 7 Days |
| |||||||||||||
| Second Intervention Day 1 |
| |||||||||||||
| Wash Out 7 Days |
| |||||||||||||
| Third Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The AUC it is estimated across the timepoints above and across the different number of patients per arm. | Posted | Mean | Standard Deviation | mmol/L*min | 480 minutes |
|
4 weeks
No difference
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Palm Olein | palm olein: 60g of interesterified palm olein will be given in a milkshake at breakfast |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Gary Frost | Imperial College London | 020 7589 5111 | g.frost@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 12, 2016 | Mar 16, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013024 | Soybean Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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Number of participants 12
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| Interesterified palm olein | Dietary Supplement | 60g of interesterified palm olein will be given in a milkshake at breakfast |
|
| Soybean oil | Dietary Supplement | 60g of soybean oil will be given in a milkshake at breakfast |
|
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. |
| ime (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480. Time Frame: 480 minutes |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Age | Mean | Full Range | years |
|
| Body Weight | Mean | Standard Deviation | kilograms |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| % Body Fat | Mean | Standard Deviation | percentage |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Heart Rate | Mean | Standard Deviation | bpm |
|
| OG002 | Interesterified Palm Olein | Interesterified palm olein: 60g of interesterified palm olein will be given in a milkshake at breakfast |
|
|
| 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 | The AUC it is estimated across the timepoints above and across the different number of patients per arm. | Posted | Mean | Standard Deviation | mmol/L*min | 480 min |
|
|
|
| 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. | Posted | Mean | Standard Error | mmol/L*min | ime (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480. Time Frame: 480 minutes |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Interesterified Palm Olein | Interesterified palm olein: 60g of interesterified palm olein will be given in a milkshake at breakfast | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Soya Bean | Soybean oil: 60g of soybean oil will be given in a milkshake at breakfast | 0 | 12 | 0 | 12 | 0 | 12 |
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| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |