InflammationNCT01665482
Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity
A study testing A 2000 kcal test meal and A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate in people with Inflammation and Insulin Sensitivity, run by Malaysia Palm Oil Board at 1 site in Malaysia.
Trial summary
Rationale: It is well established that increased intake of saturated fatty acids (SFA) is associated with incidence of cardiovascular heart disease (CHD). This effect is mediated by dietary saturated fat's impact on fasting plasma cholesterol levels. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Insulin Sensitivity
- What is being tested?
- A 2000 kcal test meal and A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteMalaysia
- Study dates
- Mar 2012to Jul 2012
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Abdominally obese males and females (waist circumference > 90 cm for male, > 80 cm for female),
- Age 20-60 years
Who cannot join
- a medical history of cardiovascular disease, diabetes, dyslipidemia;
- current use of antihypertensive or lipid lowering medication;
- plasma cholesterol > 6.5 mmol/L, TAG > 4.5 mmol/L;
- alcohol intake exceeding a moderate intake (> 28 units per week);
- pregnancy,
- smoker and
- breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: It is well established that increased intake of saturated fatty acids (SFA) is associated with incidence of cardiovascular heart disease (CHD). This effect is mediated by dietary saturated fat's impact on fasting plasma cholesterol levels. Research is needed to clarify the association between dietary fatty acids and metabolic risk markers beyond lipid profile. World Health Organisation (WHO) has recommended reduced intake of SFA with energy replacement from monounsaturated fatty acids (MUFA) or carbohydrates (CARB). However, limited evidence is available on the effects of dietary fatty acids on insulin sensitivity and secretion. The current study is designed to investigate the effects of SFA versus MUFA versus CARB on insulinemic response and lipid metabolism in healthy individuals with central obesity.
Study design: A randomized, crossover, single blind design study was carried out. The subjects consumed controlled diets for 6 weeks each. They were provided 3 meals per day during weekdays in which SFA, MUFA and CARB diet was assigned to them randomly. Protein content was standardised at 14% energy. The SFA and MUFA diets each provided 31.5% energy intake from fat, with 69% of the total fats replaced by test fats (approximately 49 g/d based on a 2000 kcal basic diet). Each individual fatty acid provided approximately 7% of the total energy intake. The CARB diet provided approximately 34 g/day experimental fat based on a 2000 kcal basic diet. The CARB diet replaced 7 % energy of carbohydrate from total fat with the exchange from oleic acid (C18:1).
Hypothesis: Changing energy from dietary fat (SFA and MUFA) to carbohydrate will influence insulin sensitivity, endothelial and vascular function, pro-inflammatory markers and lipid metabolism differently in individuals with metabolic syndrome. SFA (palm olein) may be comparable with MUFA (high oleic sunflower oil) with regards to its effects on insulin sensitivity, endothelial and vascular function and inflammation
- Conditions
- Inflammation, Insulin Sensitivity
- Being tested
- A 2000 kcal test meal, A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate
- Keywords
- Inflammation, Insulin sensitivity, Interleukin-6 (IL-6), C-peptide, Saturated fatty acid (SFA), Monounsaturated fatty acid (MUFA), Carbohydrate (CARB)
- Medical subject headings
- Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 2000 kcal test mealOther
A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrateOther
| Study group | Role | What they receive |
|---|---|---|
| Saturated fat rich diet | Active comparator | Not described Receives: Other: A 2000 kcal test meal |
| Monounsaturated fat rich diet | Active comparator | Not described Receives: Other: A 2000 kcal test meal |
| Carbohydrate/ Low fat diet | Active comparator | Not described Receives: Other: A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6
Measured: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.
C-peptide
Measured: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.
Secondary outcomes (1)
hsCRP
Measured: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2012
- Study completionJul 2012
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 InflammationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Collaborators
- University of Malaya
- Responsible party
- Sponsor
- Investigators
- Teng Kim Tiu, PhD, Principal investigator, MPOB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665482
- Sponsor's protocol ID
- PD155/11
- Status last verified
- Aug 2012
- First submitted
- 12 Aug 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chang LF, Vethakkan SR, Nesaretnam K, Sanders TA, Teng KT. Adverse effects on insulin secretion of replacing saturated fat with refined carbohydrate but not with monounsaturated fat: A randomized controlled trial in centrally obese subjects. J Clin Lipidol. 2016 Nov-Dec;10(6):1431-1441.e1. doi: 10.1016/j.jacl.2016.09.006. Epub 2016 Sep 17.
PubMed 27919361Teng KT, Chang LF, Vethakkan SR, Nesaretnam K, Sanders TAB. Effects of exchanging carbohydrate or monounsaturated fat with saturated fat on inflammatory and thrombogenic responses in subjects with abdominal obesity: A randomized controlled trial. Clin Nutr. 2017 Oct;36(5):1250-1258. doi: 10.1016/j.clnu.2016.08.026. Epub 2016 Sep 8.
PubMed 27642057
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity
- ClinicalTrials.gov ID
- NCT01665482
- Acronym / sponsor ID
- PD155/11
- Conditions
- Inflammation, Insulin Sensitivity
- Keywords
- Inflammation, Insulin sensitivity, Interleukin-6 (IL-6), C-peptide, Saturated fatty acid (SFA), Monounsaturated fatty acid (MUFA), Carbohydrate (CARB)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Collaborators
- University of Malaya
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 Aug 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.
Rationale: It is well established that increased intake of saturated fatty acids (SFA) is associated with incidence of cardiovascular heart disease (CHD). This effect is mediated by dietary saturated fat's impact on fasting plasma cholesterol levels. Research is needed to clarify the association between dietary fatty acids and metabolic risk markers beyond lipid profile. World Health Organisation (WHO) has recommended reduced intake of SFA with energy replacement from monounsaturated fatty acids (MUFA) or carbohydrates (CARB). However, limited evidence is available on the effects of dietary fatty acids on insulin sensitivity and secretion. The current study is designed to investigate the effects of SFA versus MUFA versus CARB on insulinemic response and lipid metabolism in healthy individuals with central obesity.
Study design: A randomized, crossover, single blind design study was carried out. The subjects consumed controlled diets for 6 weeks each. They were provided 3 meals per day during weekdays in which SFA, MUFA and CARB diet was assigned to them randomly. Protein content was standardised at 14% energy. The SFA and MUFA diets each provided 31.5% energy intake from fat, with 69% of the total fats replaced by test fats (approximately 49 g/d based on a 2000 kcal basic diet). Each individual fatty acid provided approximately 7% of the total energy intake. The CARB diet provided approximately 34 g/day experimental fat based on a 2000 kcal basic diet. The CARB diet replaced 7 % energy of carbohydrate from total fat with the exchange from oleic acid (C18:1).
Hypothesis: Changing energy from dietary fat (SFA and MUFA) to carbohydrate will influence insulin sensitivity, endothelial and vascular function, pro-inflammatory markers and lipid metabolism differently in individuals with metabolic syndrome. SFA (palm olein) may be comparable with MUFA (high oleic sunflower oil) with regards to its effects on insulin sensitivity, endothelial and vascular function and inflammation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saturated fat rich diet | Active comparator | Other: A 2000 kcal test meal |
| Monounsaturated fat rich diet | Active comparator | Other: A 2000 kcal test meal |
| Carbohydrate/ Low fat diet | Active comparator | Other: A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Abdominally obese males and females (waist circumference > 90 cm for male, > 80 cm for female),
- Age 20-60 years
Key exclusion criteria (7 listed)
- a medical history of cardiovascular disease, diabetes, dyslipidemia;
- current use of antihypertensive or lipid lowering medication;
- plasma cholesterol > 6.5 mmol/L, TAG > 4.5 mmol/L;
- alcohol intake exceeding a moderate intake (> 28 units per week);
- pregnancy,
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 |
|---|---|---|
| A 2000 kcal test meal | Other | Monounsaturated fat rich diet, Saturated fat rich diet |
| A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate | Other | Carbohydrate/ Low fat diet |
Primary outcome
Interleukin-6
Time frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.
C-peptide
Time frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.
1 secondary outcome
hsCRP
Time frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.
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 15 Aug 2012.
- Derived from this study: PubMed 27919361Chang LF, Vethakkan SR, Nesaretnam K, Sanders TA, Teng KT. Adverse effects on insulin secretion of replacing saturated fat with refined carbohydrate but not with monounsaturated fat: A randomized controlled trial in centrally obese subjects. J Clin Lipidol. 2016 Nov-Dec;10(6):1431-1441.e1. doi: 10.1016/j.jacl.2016.09.006. Epub 2016 Sep 17.
- Derived from this study: PubMed 27642057Teng KT, Chang LF, Vethakkan SR, Nesaretnam K, Sanders TAB. Effects of exchanging carbohydrate or monounsaturated fat with saturated fat on inflammatory and thrombogenic responses in subjects with abdominal obesity: A randomized controlled trial. Clin Nutr. 2017 Oct;36(5):1250-1258. doi: 10.1016/j.clnu.2016.08.026. Epub 2016 Sep 8.
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
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.
Teng Kim Tiu, PhD principal investigator
MPOB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A 2000 kcal test meal and A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate in people with Inflammation and Insulin Sensitivity, run by Malaysia Palm Oil Board at 1 site 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 2 inclusion and 7 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 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Interleukin-6 (time frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.). 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 NCT01665482, 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 15 Aug 2012.