Metabolic SyndromeNCT01571947
Acute Effects of Dietary Fats and Carbohydrate in Subjects With Metabolic Syndrome
A study testing Acute Effects of Fats and Carbohydrate in people with Metabolic Syndrome, run by Malaysia Palm Oil Board at 2 sites in Malaysia.
Trial summary
There is increasing evidence suggests that elevated levels of postprandial triacylglycerol (TAG)-rich lipoproteins may promote the development of cardiovascular diseases (CVD). A prolonged and elevated postprandial lipemia is associated with increased risk of CVD by a variety of mechanisms such as insulin resistance… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Acute Effects of Fats and Carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesMalaysia
- Study dates
- Nov 2011to Jul 2014
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 - 60
- Elevated TAG with at least 1.7 mmol/L
- Low HDL cholesterol (< 1.04 mmol/L for men, 1.3 mmol/L for women)
- Elevated blood pressure (systolic at least 130, diastolic at least 85 mmHg)
- Increased waist circumference (at least 90cm for men, 80cm for women)
- Fasting plasma glucose between 5.6 and 7.0 mmol/L
Who cannot join
- Underweight
- Current use of antihypertensive or lipid lowering medication
- Alcohol intake exceeding a moderate intake (> 28 units per week)
- Medical history of myocardial infarction, angina, thrombosis, stroke, cancer or diabetes
- Pregnancy or breast-feeding
- Smoker
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
Malaysia Palm oil Board
Kajang, Selangor, 43000
Malaysian Palm Oil Board (MPOB)
Kajang, Selangor, 43000
About this study
Official title: Acute Effects of Dietary Fats and Carbohydrate on Insulinaemia, Lipaemia, Inflammatory Responses and Gastrointestinal Peptide Secretion in Subjects With Metabolic Syndrome
There is increasing evidence suggests that elevated levels of postprandial triacylglycerol (TAG)-rich lipoproteins may promote the development of cardiovascular diseases (CVD). A prolonged and elevated postprandial lipemia is associated with increased risk of CVD by a variety of mechanisms such as insulin resistance, inflammation, endothelial dysfunction and oxidative stress. However, current evidence on the acute effects of type of fats on postprandial insulinaemia, gastrointestinal peptide secretion, inflammatory response, as well as satiation are limited and inconsistent, in particular in metabolic syndrome population in Asian. Hence, this study aimed to investigate the postprandial effects of high fat meals enriched with i) palm olein, ii) high oleic sunflower oil, and iii) high linoleic sunflower oil, compared with a low fat/high carbohydrate meal, in 30 subjects with metabolic syndrome.
Read the detailed description
A randomized, double-blind, crossover design study was conducted to test the acute effects of high fat meals enriched with (1) saturated fatty acids (SFA); (2) monounsaturated fatty acids (MUFA); (3) polyunsaturated fatty acids (PUFA) vs. (4) a low fat/high carbohydrate (CARB) meal on postprandial insulinaemic, lipaemic and inflammatory responses, as well as gastrointestinal peptide secretion and satiation on 30 metabolic syndrome subjects (15 men and 15 women). Primary outcome of this study is postprandial changes of C-peptide. Other measured outcomes including insulin and glucose responses, lipids, cytokines and gastrointestinal peptides. Subjective appetite measurements were taken as exploratory outcomes using visual analogue scales.
Subjects were asked to participate in four postprandial challenges, separated by at least one week. On the day preceding the postprandial intervention, subjects were provided a low fat meal (< 10 g) to consume as their evening meal. They were required to fast over night after 10 pm and arrive at the research unit at 7:30 am - 9:00 am the following morning. Fasting blood samples were collected and subjects were instructed to consume the allocated test meal within 10 minutes. Further venous blood will be collected at regular intervals for up to 6 hours postprandially. During the 6 hours of the experimental study, the subjects were refrained from the consumption of any food or drink except plain water which they will be asked to consume at regular intervals (up to 750 mL over the 6 hours).
- Conditions
- Metabolic Syndrome
- Being tested
- Acute Effects of Fats and Carbohydrate
- Keywords
- Insulinaemia, inflammatory markers, gastrointestinal peptides, SFA, dietary fats, carbohydrate, insulin sensitivity
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Effects of Fats and CarbohydrateOther
Test meals were served in the form of muffin + milkshake. For high fat meals, 55g of test fat will be incorporated in muffins, whereas 22g of fat for low fat or high carbohydrate test meal. During study day, subjects were to consume the allocated test meal within 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| SFA | Active comparator | Not described Receives: Other: Acute Effects of Fats and Carbohydrate |
| MUFA | Active comparator | Not described Receives: Other: Acute Effects of Fats and Carbohydrate |
| PUFA | Active comparator | Not described Receives: Other: Acute Effects of Fats and Carbohydrate |
| CARB | Active comparator | Not described Receives: Other: Acute Effects of Fats and Carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-peptide
Measured: 6 hours (0, 15, 30, 60, 90, 120, 180, 240, 300 and 360 min)
Secondary outcomes (1)
Insulin
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2012
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Collaborators
- University of Malaya
- Responsible party
- Sponsor
- Investigators
- Kim-Tiu Teng, PhD, Principal investigator, Malaysia Palm Oil Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571947
- Sponsor's protocol ID
- A003.11
- Status last verified
- Jul 2014
- First submitted
- 3 Apr 2012
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chang CY, Kanthimathi MS, Tan AT, Nesaretnam K, Teng KT. The amount and types of fatty acids acutely affect insulin, glycemic and gastrointestinal peptide responses but not satiety in metabolic syndrome subjects. Eur J Nutr. 2018 Feb;57(1):179-190. doi: 10.1007/s00394-016-1307-9. Epub 2016 Sep 8.
PubMed 27632019Teng KT, Chang CY, Kanthimathi MS, Tan AT, Nesaretnam K. Effects of amount and type of dietary fats on postprandial lipemia and thrombogenic markers in individuals with metabolic syndrome. Atherosclerosis. 2015 Sep;242(1):281-7. doi: 10.1016/j.atherosclerosis.2015.07.003. Epub 2015 Jul 7.
PubMed 26232169
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Dietary Fats and Carbohydrate on Insulinaemia, Lipaemia, Inflammatory Responses and Gastrointestinal Peptide Secretion in Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01571947
- Acronym / sponsor ID
- A003.11
- Conditions
- Metabolic Syndrome
- Keywords
- Insulinaemia, inflammatory markers, gastrointestinal peptides, SFA, dietary fats, carbohydrate, insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Collaborators
- University of Malaya
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Apr 2012 (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.
There is increasing evidence suggests that elevated levels of postprandial triacylglycerol (TAG)-rich lipoproteins may promote the development of cardiovascular diseases (CVD). A prolonged and elevated postprandial lipemia is associated with increased risk of CVD by a variety of mechanisms such as insulin resistance, inflammation, endothelial dysfunction and oxidative stress. However, current evidence on the acute effects of type of fats on postprandial insulinaemia, gastrointestinal peptide secretion, inflammatory response, as well as satiation are limited and inconsistent, in particular in metabolic syndrome population in Asian. Hence, this study aimed to investigate the postprandial effects of high fat meals enriched with i) palm olein, ii) high oleic sunflower oil, and iii) high linoleic sunflower oil, compared with a low fat/high carbohydrate meal, in 30 subjects with metabolic syndrome.
Detailed description
A randomized, double-blind, crossover design study was conducted to test the acute effects of high fat meals enriched with (1) saturated fatty acids (SFA); (2) monounsaturated fatty acids (MUFA); (3) polyunsaturated fatty acids (PUFA) vs. (4) a low fat/high carbohydrate (CARB) meal on postprandial insulinaemic, lipaemic and inflammatory responses, as well as gastrointestinal peptide secretion and satiation on 30 metabolic syndrome subjects (15 men and 15 women). Primary outcome of this study is postprandial changes of C-peptide. Other measured outcomes including insulin and glucose responses, lipids, cytokines and gastrointestinal peptides. Subjective appetite measurements were taken as exploratory outcomes using visual analogue scales.
Subjects were asked to participate in four postprandial challenges, separated by at least one week. On the day preceding the postprandial intervention, subjects were provided a low fat meal (< 10 g) to consume as their evening meal. They were required to fast over night after 10 pm and arrive at the research unit at 7:30 am - 9:00 am the following morning. Fasting blood samples were collected and subjects were instructed to consume the allocated test meal within 10 minutes. Further venous blood will be collected at regular intervals for up to 6 hours postprandially. During the 6 hours of the experimental study, the subjects were refrained from the consumption of any food or drink except plain water which they will be asked to consume at regular intervals (up to 750 mL over the 6 hours).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SFA | Active comparator | Other: Acute Effects of Fats and Carbohydrate |
| MUFA | Active comparator | Other: Acute Effects of Fats and Carbohydrate |
| PUFA | Active comparator | Other: Acute Effects of Fats and Carbohydrate |
| CARB | Active comparator | Other: Acute Effects of Fats and Carbohydrate |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 20 - 60
- Elevated TAG with at least 1.7 mmol/L
- Low HDL cholesterol (< 1.04 mmol/L for men, 1.3 mmol/L for women)
- Elevated blood pressure (systolic at least 130, diastolic at least 85 mmHg)
- Increased waist circumference (at least 90cm for men, 80cm for women)
Key exclusion criteria (6 listed)
- Underweight
- Current use of antihypertensive or lipid lowering medication
- Alcohol intake exceeding a moderate intake (> 28 units per week)
- Medical history of myocardial infarction, angina, thrombosis, stroke, cancer or diabetes
- Pregnancy or breast-feeding
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 |
|---|---|---|
| Acute Effects of Fats and CarbohydrateTest meals were served in the form of muffin + milkshake. For high fat meals, 55g of test fat will be incorporated in muffins, whereas 22g of fat for low fat or high carbohydrate test meal. During study day, subjects were to consume the allocated test meal within 10 minutes. | Other | CARB, MUFA, PUFA, SFA |
Primary outcome
C-peptide
Time frame: 6 hours (0, 15, 30, 60, 90, 120, 180, 240, 300 and 360 min)
1 secondary outcome
Insulin
Time frame: 6 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 2014.
- Derived from this study: PubMed 27632019Chang CY, Kanthimathi MS, Tan AT, Nesaretnam K, Teng KT. The amount and types of fatty acids acutely affect insulin, glycemic and gastrointestinal peptide responses but not satiety in metabolic syndrome subjects. Eur J Nutr. 2018 Feb;57(1):179-190. doi: 10.1007/s00394-016-1307-9. Epub 2016 Sep 8.
- Derived from this study: PubMed 26232169Teng KT, Chang CY, Kanthimathi MS, Tan AT, Nesaretnam K. Effects of amount and type of dietary fats on postprandial lipemia and thrombogenic markers in individuals with metabolic syndrome. Atherosclerosis. 2015 Sep;242(1):281-7. doi: 10.1016/j.atherosclerosis.2015.07.003. Epub 2015 Jul 7.
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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.
Kim-Tiu Teng, PhD principal investigator
Malaysia Palm Oil Board
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Effects of Fats and Carbohydrate in people with Metabolic Syndrome, run by Malaysia Palm Oil Board at 2 sites in Malaysia.
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 6 inclusion and 6 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 2014. 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 Malaysia. 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?
C-peptide (time frame: 6 hours (0, 15, 30, 60, 90, 120, 180, 240, 300 and 360 min)). 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 NCT01571947, which also lists 2 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 2014.