HyperlipidemiaNCT02506920
Gender Dependent Difference in Lipemia After 6 x OFTT in Young Healthy Subjects
A study testing Six different types of fat in a meal in random order in people with Hyperlipidemia, run by Herning Hospital.
Trial summary
The investigators wanted to study the postprandial lipemia after six oral fat tolerance test with varying amounts of saturated fat in young healthy subjects. Read more about this study
- Who is it for?
- Ages 22 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Six different types of fat in a meal in random order
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jan 1997to Dec 1997
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Accept healthy volunteers
Who cannot join
- hypercholesterolemia,
- hypertension,
- abuse of drugs or alcohol,
- known kidney, liver, heart and metabolic disease
- hormonal therapies including oral contraceptives
About this study
Official title: Gender Dependent Difference in Postprandial Lipemia and Glucose Responses After Six Different Fat Tolerance Tests in Young Healthy Subjects
The investigators wanted to study the postprandial lipemia after six oral fat tolerance test with varying amounts of saturated fat in young healthy subjects.
Read the detailed description
With six different types of butter added in random order to potatoes the investigators studied postprandial lipemia (PPL), lipoprotein, glucose, and insulin increments for eight hours in 14 young, lean, healthy students, seven of each gender.
The six, isocaloric meals contained 55.1 g carbohydrate, 5.8 g protein, 82.3 g fat, and 4177 kJ. The potatoes, without skin, were boiled in 20 minutes in excess of water with 5 g of salt added, were blended in 4 minutes and served hot. The meals were ingested over 10 minutes, with 250 ml tap water. The following 8 hours the participants stayed at the clinic to watch television, read or take a short walk of 10 minutes.
Blood samples were drawn at -15, 0, 30, 60, 90,120,180,240,300,360, 420 and 480 minutes after the meals and processed after each drawing. After blood collection, plasma was immediately separated by centrifugation at 3000 rpm for 10 minutes at 4°C.
The area under the curve (AUC) were determined for TG, HDL, LDL, total cholesterol, FFA, insulin, and glucose concentrations by the trapezoid method. Multiple regression was performed to adjust for age, gender, meals, and BMI to the variance of postprandial responses. The difference between meals were tested with ANOVA. If p<0.05 in ANOVA, post-hoc-testing with Student-Newman-Keul's test was performed to identify, which meal was significantly different from the other, and to minimize the risk of error by multiple testing.
- Conditions
- Hyperlipidemia
- Being tested
- Six different types of fat in a meal in random order
- Keywords
- Postprandial lipemia, glycemic response
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six different types of fat in a meal in random orderDietary supplement
Oral fat tolerance test
| Study group | Role | What they receive |
|---|---|---|
| Pack butter | Active comparator | Oral fat tolerance test contains: Cream, lactic acid culture, salt. Fat contents in grams: Saturated fat (SFA) 52, monounsaturated fat (MUFA) 19.1, polyunsaturated fat (PUFA) 1.6 Receives: Dietary Supplement: Six different types of fat in a meal in random order |
| Kjaergaarden blend butter | Active comparator | Oral fat tolerance test contains:Butter rapeseed oil, lactic acid culture, salt. Fat contents in grams: SFA 37.4, MUFA 27.3, PUFA 1.8 Receives: Dietary Supplement: Six different types of fat in a meal in random order |
| Blend butter | Active comparator | Oral fat tolerance test contains: Butter rapeseed oil, lactic acid culture, salt. Fat contents in grams: SFA 23.7, MUFA 23.2, PUFA 7.8 Receives: Dietary Supplement: Six different types of fat in a meal in random order |
| Fish oil enriched butter | Active comparator | Oral fat tolerance test contains: Butter rapeseed oil, lactic acid culture, fish oil, salt. Fat contents in grams: SFA 22.6, MUFA 26.9, PUFA 0.7 Receives: Dietary Supplement: Six different types of fat in a meal in random order |
| Olive oil enriched butter | Active comparator | Oral fat tolerance test contains: Butter rapeseed oil, olive oil, lactic acid culture, salt. Fat contents in grams: SFA 22.6, MUFA 26.9, PUFA 5.7 Receives: Dietary Supplement: Six different types of fat in a meal in random order |
| Low saturated fat butter | Active comparator | Oral fat tolerance test contains: Butter, lactic acid culture, salt. Fat contents in grams: SFA14.9, MUFA16, PUFA 5.6 Receives: Dietary Supplement: Six different types of fat in a meal in random order |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial cholesterol
Cholesterols measured in milli mol per liter
Measured: Eight hours
Postprandial free fatty acids
Free fatty acids measured in micro equivalents per liter
Measured: Eight hours
Secondary outcomes (2)
Postprandial glucose
Glucose measured in milli mol per liter
Measured: Eight hours
postprandial insulin
Insulin measured in pico mol per liter
Measured: Eight hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJan 1997
- Primary completionApr 1997
- Study completionDec 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kolding Sygehus
- Responsible party
- Principal investigator, Finn Friis Lauszus, Herning Hospital
- Investigators
- Ole W Rasmussen, DrMedScie, Principal investigator, Associate Professor, Kolding Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506920
- Sponsor's protocol ID
- Gender and PPL
- Status last verified
- Jul 2015
- First submitted
- 26 Jun 2015
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Astrup A, Dyerberg J, Elwood P, Hermansen K, Hu FB, Jakobsen MU, Kok FJ, Krauss RM, Lecerf JM, LeGrand P, Nestel P, Riserus U, Sanders T, Sinclair A, Stender S, Tholstrup T, Willett WC. The role of reducing intakes of saturated fat in the prevention of cardiovascular disease: where does the evidence stand in 2010? Am J Clin Nutr. 2011 Apr;93(4):684-8. doi: 10.3945/ajcn.110.004622. Epub 2011 Jan 26.
PubMed 21270379Ryan MF, O'Grada CM, Morris C, Segurado R, Walsh MC, Gibney ER, Brennan L, Roche HM, Gibney MJ. Within-person variation in the postprandial lipemic response of healthy adults. Am J Clin Nutr. 2013 Feb;97(2):261-7. doi: 10.3945/ajcn.112.047936. Epub 2013 Jan 2.
PubMed 23283501Knuth ND, Remias DB, Horowitz JF. Adding carbohydrate to a high-fat meal blunts postprandial lipemia in women and reduces meal-derived fatty acids in systemic circulation. Appl Physiol Nutr Metab. 2008 Apr;33(2):315-25. doi: 10.1139/H07-190.
PubMed 18347687Tentor J, Harada LM, Nakamura RT, Gidlund M, Castilho LN, Cotta de Faria E. Sex-dependent variables in the modulation of postalimentary lipemia. Nutrition. 2006 Jan;22(1):9-15. doi: 10.1016/j.nut.2005.05.004. Epub 2005 Oct 12.
PubMed 16226013
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Dependent Difference in Postprandial Lipemia and Glucose Responses After Six Different Fat Tolerance Tests in Young Healthy Subjects
- ClinicalTrials.gov ID
- NCT02506920
- Acronym / sponsor ID
- Gender and PPL
- Conditions
- Hyperlipidemia
- Keywords
- Postprandial lipemia, glycemic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Collaborators
- Kolding Sygehus
- Study start
- Jan 1997
- Primary completion
- Apr 1997 (actual)
- Study completion
- Dec 1997 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators wanted to study the postprandial lipemia after six oral fat tolerance test with varying amounts of saturated fat in young healthy subjects.
Detailed description
With six different types of butter added in random order to potatoes the investigators studied postprandial lipemia (PPL), lipoprotein, glucose, and insulin increments for eight hours in 14 young, lean, healthy students, seven of each gender.
The six, isocaloric meals contained 55.1 g carbohydrate, 5.8 g protein, 82.3 g fat, and 4177 kJ. The potatoes, without skin, were boiled in 20 minutes in excess of water with 5 g of salt added, were blended in 4 minutes and served hot. The meals were ingested over 10 minutes, with 250 ml tap water. The following 8 hours the participants stayed at the clinic to watch television, read or take a short walk of 10 minutes.
Blood samples were drawn at -15, 0, 30, 60, 90,120,180,240,300,360, 420 and 480 minutes after the meals and processed after each drawing. After blood collection, plasma was immediately separated by centrifugation at 3000 rpm for 10 minutes at 4°C.
The area under the curve (AUC) were determined for TG, HDL, LDL, total cholesterol, FFA, insulin, and glucose concentrations by the trapezoid method. Multiple regression was performed to adjust for age, gender, meals, and BMI to the variance of postprandial responses. The difference between meals were tested with ANOVA. If p<0.05 in ANOVA, post-hoc-testing with Student-Newman-Keul's test was performed to identify, which meal was significantly different from the other, and to minimize the risk of error by multiple testing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pack butter | Active comparator | Dietary Supplement: Six different types of fat in a meal in random orderOral fat tolerance test contains: Cream, lactic acid culture, salt. Fat contents in grams: Saturated fat (SFA) 52, monounsaturated fat (MUFA) 19.1, polyunsaturated fat (PUFA) 1.6 |
| Kjaergaarden blend butter | Active comparator | Dietary Supplement: Six different types of fat in a meal in random orderOral fat tolerance test contains:Butter rapeseed oil, lactic acid culture, salt. Fat contents in grams: SFA 37.4, MUFA 27.3, PUFA 1.8 |
| Blend butter | Active comparator | Dietary Supplement: Six different types of fat in a meal in random orderOral fat tolerance test contains: Butter rapeseed oil, lactic acid culture, salt. Fat contents in grams: SFA 23.7, MUFA 23.2, PUFA 7.8 |
| Fish oil enriched butter | Active comparator | Dietary Supplement: Six different types of fat in a meal in random orderOral fat tolerance test contains: Butter rapeseed oil, lactic acid culture, fish oil, salt. Fat contents in grams: SFA 22.6, MUFA 26.9, PUFA 0.7 |
| Olive oil enriched butter | Active comparator | Dietary Supplement: Six different types of fat in a meal in random orderOral fat tolerance test contains: Butter rapeseed oil, olive oil, lactic acid culture, salt. Fat contents in grams: SFA 22.6, MUFA 26.9, PUFA 5.7 |
| Low saturated fat butter | Active comparator | Dietary Supplement: Six different types of fat in a meal in random orderOral fat tolerance test contains: Butter, lactic acid culture, salt. Fat contents in grams: SFA14.9, MUFA16, PUFA 5.6 |
Who may qualify
- Ages
- 22 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Accept healthy volunteers
Key exclusion criteria (5 listed)
- hypercholesterolemia,
- hypertension,
- abuse of drugs or alcohol,
- known kidney, liver, heart and metabolic disease
- hormonal therapies including oral contraceptives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six different types of fat in a meal in random orderOral fat tolerance test | Dietary supplement | Blend butter, Fish oil enriched butter, Kjaergaarden blend butter, Low saturated fat butter, Olive oil enriched butter, Pack butter |
Primary outcome
Postprandial cholesterol
Time frame: Eight hours
Cholesterols measured in milli mol per liter
Postprandial free fatty acids
Time frame: Eight hours
Free fatty acids measured in micro equivalents per liter
2 secondary outcomes
Postprandial glucose
Time frame: Eight hours
postprandial insulin
Time frame: Eight hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- Background: PubMed 21270379Astrup A, Dyerberg J, Elwood P, Hermansen K, Hu FB, Jakobsen MU, Kok FJ, Krauss RM, Lecerf JM, LeGrand P, Nestel P, Riserus U, Sanders T, Sinclair A, Stender S, Tholstrup T, Willett WC. The role of reducing intakes of saturated fat in the prevention of cardiovascular disease: where does the evidence stand in 2010? Am J Clin Nutr. 2011 Apr;93(4):684-8. doi: 10.3945/ajcn.110.004622. Epub 2011 Jan 26.
- Background: PubMed 23283501Ryan MF, O'Grada CM, Morris C, Segurado R, Walsh MC, Gibney ER, Brennan L, Roche HM, Gibney MJ. Within-person variation in the postprandial lipemic response of healthy adults. Am J Clin Nutr. 2013 Feb;97(2):261-7. doi: 10.3945/ajcn.112.047936. Epub 2013 Jan 2.
- Background: PubMed 18347687Knuth ND, Remias DB, Horowitz JF. Adding carbohydrate to a high-fat meal blunts postprandial lipemia in women and reduces meal-derived fatty acids in systemic circulation. Appl Physiol Nutr Metab. 2008 Apr;33(2):315-25. doi: 10.1139/H07-190.
- Background: PubMed 16226013Tentor J, Harada LM, Nakamura RT, Gidlund M, Castilho LN, Cotta de Faria E. Sex-dependent variables in the modulation of postalimentary lipemia. Nutrition. 2006 Jan;22(1):9-15. doi: 10.1016/j.nut.2005.05.004. Epub 2005 Oct 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole W Rasmussen, DrMedScie principal investigator
Associate Professor, Kolding Hospital, Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Six different types of fat in a meal in random order in people with Hyperlipidemia, run by Herning Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial cholesterol (time frame: Eight hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506920, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.