Healthy MenINTERFATNCT02365987
The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety
A study testing Interesterified blend of palm kernal and plam stearin and Un-interesterified blend of palm kernal and plam stearin in people with Healthy Men, run by King's College London at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used in commercial spreads versus the corresponding un-interesterified blend. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men
- What is being tested?
- Interesterified blend of palm kernal and plam stearin and Un-interesterified blend of palm kernal and plam stearin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Feb 2015to Dec 2015
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-45
- Male
- Healthy (free of diagnosed diseases listed in exclusion criteria)
- Able to understand the information sheet and willing to comply with study protocol
- Able to give informed consent
Who cannot join
- Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes
- Body mass index < 20 kg/m2 or > 35 kg/m2
- Plasma cholesterol ≥7.5 mmol/L
- Plasma triacylglycerol > 3 mmol/L
- Plasma glucose > 7 mmol/L
- Blood pressure ≥160/100 mmHg
Show all 11Show fewer
- Current use of antihypertensive or lipid lowering medications
- Alcohol intake exceeding a moderate intake (> 28 units per week)
- Current cigarette smoker
- ≥ 20% 10-year risk of cardiovascular disease as calculated using risk calculator
- Ingestion of paracetamol in the preceding 24 hrs to study days
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Diabetes and Nutritional Sciences Division, School of Medicine, Kings College London
London, London, SE1 9NH
Diabetes and Nutritional Sciences Division, School of Medicine, Kings College London
London, SE1 9NH
About this study
Official title: The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety: a Randomised Controlled Trial. The INTER-FAT Study
The purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used in commercial spreads versus the corresponding un-interesterified blend.
Read the detailed description
Aim: The current study aims to investigate the acute effects of commercially relevant interesterified 'hardstock' versus the corresponding un-interesterified blend on postprandial lipaemia, glycaemia, insulinaemia and gut hormone responses. Due to the previously observed differences in gut hormones following interesterified palm oil and un-interesterified palm oil by our group, we will also explore acute effects of these fats on satiety and rates of gastric emptying.
Hypothesis: Interesterification of a palm kernel and palm stearin fat blend, to produce a fat with a higher proportion of palmitic acid in the middle position of the TAG (but the same fatty acid composition), will alter postprandial lipid and glucose metabolism. It is also hypothesised that differences in rates of absorption between the test fats will influence gut hormone responses and feelings of satiety.
Subjects: Participants will include 10 healthy male volunteers. In order to determine the 'typical' response to the test fats, subjects must not be affected by metabolic syndrome in any way (obesity, dyslipidemia, insulin resistance or hypertension), they must be non-smokers (since smoking influences postprandial lipaemia), and be aged between the ages of 18 and 45 years (since above this age metabolic changes may take place that may affect the way that the body digests and metabolises lipids). Male volunteers have been selected as they elicit a higher postprandial lipaemic response to a given fat load and therefore are more sensitive to dietary manipulation.
Power calculation: A sample size of 10 has 80% power to detect a difference between means of 112.74 units in area under the curve in plasma TAG with a significance level (alpha) of 0.05 (two-tailed).
Expected value:
The study will provide novel information on the acute effects of commercially relevant spreads on postprandial lipaemia and satiety. It will also explore possible mechanisms for the predicted reduced lipaemia following the interesterified fat from measurements of gastric emptying.
- Conditions
- Healthy Men
- Being tested
- Interesterified blend of palm kernal and plam stearin, Un-interesterified blend of palm kernal and plam stearin
- Keywords
- interesterified, postprandial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interesterified blend of palm kernal and plam stearinDietary supplement
Also called Interesterified blend
50g fat provided as interesterified palm kernal and palm sterin blend in a single meal
Un-interesterified blend of palm kernal and plam stearinDietary supplement
Also called Un-interesterified blend
50g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal
| Study group | Role | What they receive |
|---|---|---|
| Interesterified | Experimental | Interesterified blend of palm kernal and plam stearin. 50g fat. Receives: Dietary Supplement: Interesterified blend of palm kernal and plam stearin |
| Un-interesterified | Active comparator | Un-interesterified blend of palm kernal and plam stearin. 50g fat. Receives: Dietary Supplement: Un-interesterified blend of palm kernal and plam stearin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial lipaemia (Postprandial plasma triacylglycerol concentrations)
Postprandial plasma triacylglycerol concentrations
Measured: Postprandial 4 hrs
Secondary outcomes (2)
Glycemia (Postprandial plasma glucose and insulin concentrations)
Postprandial plasma glucose and insulin concentrations
Measured: Postprandial 4 hrs
Gut hormones (Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations)
Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations
Measured: Postprandial 4 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy MenStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sarah Berry, King's College London
- Investigators
- Sarah EE Berry, BSc,MSc,PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365987
- Sponsor's protocol ID
- BDM/14/15-26
- Acronym
- INTERFAT
- Status last verified
- Mar 2017
- First submitted
- 11 Feb 2015
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hall WL, Iqbal S, Li H, Gray R, Berry SEE. Modulation of postprandial lipaemia by a single meal containing a commonly consumed interesterified palmitic acid-rich fat blend compared to a non-interesterified equivalent. Eur J Nutr. 2017 Dec;56(8):2487-2495. doi: 10.1007/s00394-016-1284-z. Epub 2016 Aug 10.
PubMed 27511058
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety: a Randomised Controlled Trial. The INTER-FAT Study
- ClinicalTrials.gov ID
- NCT02365987
- Acronym / sponsor ID
- INTERFAT / BDM/14/15-26
- Conditions
- Healthy Men
- Keywords
- interesterified, postprandial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Feb 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 purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used in commercial spreads versus the corresponding un-interesterified blend.
Detailed description
Aim: The current study aims to investigate the acute effects of commercially relevant interesterified 'hardstock' versus the corresponding un-interesterified blend on postprandial lipaemia, glycaemia, insulinaemia and gut hormone responses. Due to the previously observed differences in gut hormones following interesterified palm oil and un-interesterified palm oil by our group, we will also explore acute effects of these fats on satiety and rates of gastric emptying.
Hypothesis: Interesterification of a palm kernel and palm stearin fat blend, to produce a fat with a higher proportion of palmitic acid in the middle position of the TAG (but the same fatty acid composition), will alter postprandial lipid and glucose metabolism. It is also hypothesised that differences in rates of absorption between the test fats will influence gut hormone responses and feelings of satiety.
Subjects: Participants will include 10 healthy male volunteers. In order to determine the 'typical' response to the test fats, subjects must not be affected by metabolic syndrome in any way (obesity, dyslipidemia, insulin resistance or hypertension), they must be non-smokers (since smoking influences postprandial lipaemia), and be aged between the ages of 18 and 45 years (since above this age metabolic changes may take place that may affect the way that the body digests and metabolises lipids). Male volunteers have been selected as they elicit a higher postprandial lipaemic response to a given fat load and therefore are more sensitive to dietary manipulation.
Power calculation: A sample size of 10 has 80% power to detect a difference between means of 112.74 units in area under the curve in plasma TAG with a significance level (alpha) of 0.05 (two-tailed).
Expected value:
The study will provide novel information on the acute effects of commercially relevant spreads on postprandial lipaemia and satiety. It will also explore possible mechanisms for the predicted reduced lipaemia following the interesterified fat from measurements of gastric emptying.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interesterified | Experimental | Dietary Supplement: Interesterified blend of palm kernal and plam stearinInteresterified blend of palm kernal and plam stearin. 50g fat. |
| Un-interesterified | Active comparator | Dietary Supplement: Un-interesterified blend of palm kernal and plam stearinUn-interesterified blend of palm kernal and plam stearin. 50g fat. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18-45
- Male
- Healthy (free of diagnosed diseases listed in exclusion criteria)
- Able to understand the information sheet and willing to comply with study protocol
- Able to give informed consent
Key exclusion criteria (11 listed)
- Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes
- Body mass index < 20 kg/m2 or > 35 kg/m2
- Plasma cholesterol ≥7.5 mmol/L
- Plasma triacylglycerol > 3 mmol/L
- Plasma glucose > 7 mmol/L
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 |
|---|---|---|
| Interesterified blend of palm kernal and plam stearinAlso: Interesterified blend50g fat provided as interesterified palm kernal and palm sterin blend in a single meal | Dietary supplement | Interesterified |
| Un-interesterified blend of palm kernal and plam stearinAlso: Un-interesterified blend50g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal | Dietary supplement | Un-interesterified |
Primary outcome
Postprandial lipaemia (Postprandial plasma triacylglycerol concentrations)
Time frame: Postprandial 4 hrs
Postprandial plasma triacylglycerol concentrations
2 secondary outcomes
Glycemia (Postprandial plasma glucose and insulin concentrations)
Time frame: Postprandial 4 hrs
Gut hormones (Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations)
Time frame: Postprandial 4 hrs
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 9 Mar 2017.
- Derived from this study: PubMed 27511058Hall WL, Iqbal S, Li H, Gray R, Berry SEE. Modulation of postprandial lipaemia by a single meal containing a commonly consumed interesterified palmitic acid-rich fat blend compared to a non-interesterified equivalent. Eur J Nutr. 2017 Dec;56(8):2487-2495. doi: 10.1007/s00394-016-1284-z. Epub 2016 Aug 10.
- Individual participant dataSharing planned: No
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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.
Sarah EE Berry, BSc,MSc,PhD principal investigator
King's College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interesterified blend of palm kernal and plam stearin and Un-interesterified blend of palm kernal and plam stearin in people with Healthy Men, run by King's College London at 2 sites in United Kingdom.
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 5 inclusion and 11 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 lipaemia (Postprandial plasma triacylglycerol concentrations) (time frame: Postprandial 4 hrs). 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 NCT02365987, which also lists 1 linked publication.
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 9 Mar 2017.