Metabolic SyndromeNCT01768169
Study of Metabolic Syndrome Use Omega-3 Fatty Acids and Low Fat Meal
An observational study of Metabolic Syndrome, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
Increased understanding of the impact of long chain omega-3 PUFAs in combination with a low fat plant-based diet will contribute to decelerating further escalation of the "epidemics" of obesity, the (pre)metabolic syndrome, and T2DM in Taiwan. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- fish oil capsule
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2012to Jul 2013
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: community sample, residents of Taiwan
Who may be able to join
- Age 30 to 65 years
- Female subjects must have a negative pregnancy test at screening, must be surgically sterile or at least 6 months postmenopausal or must use a form of birth control measure.
- BMI of 24 to 40 kg/m2 inclusive.
- Subjects must be in good health other than having metabolic syndrome as determined by medical history, physical examination, and screening clinical laboratory including chemistry panel and CBC.
- Must have stable smoking habits (or be now-smokers) for at least 6 months prior to screening and agree not to intend to change such habits during the course of the study.
- Subjects requiring the regular use of any prescription medication may be admitted to the study providing the dose is stable.
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- Ethical subjects only will be admitted who are likely to comply with all visits and instructions. This will be determined in the screening phase.
- Body weight must be stable within 2% of change in the last 3 months.
- Subject must sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or randomization. A subject will be excluded for any condition that might compromise the ability to give truly informed consent for participation in the study.
Who cannot join
- Diabetes
- nown or documented coronary heart disease (CHD) (including ECG consistent with prior myocardial infraction), cerebrovascular accident (including transient ischemic attack), peripheral vascular disease (including symptoms of claudication)
- Angina or other chest pain that may indicate CHD
- Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable)
- Known abnormal liver function tests greater than 3X upper limit of normal
- Smoker, illicit drug use, or excessive alcohol use
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- Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, omega-3 fatty acid supplement, other investigational drugs within 30 days of study entry, high omega-3 fatty acid content in diet within past three months
- Pregnancy or planning pregnancy during the study period
- Sensitivity or allergy to fish
- Subjects who had undergone bypass procedure.
- Any debilitating disease such as tuberculosis, HIV etc.
- Unwillingness to give written informed consent for participation in the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Mecical University Hospital
Taipei, Taiwan, 100
Wen-Yi Cheng, 886223711458, rhoda2891@hotmail.com
Shih-Yi Huang, Ph.D.
About this study
Official title: Phase 2 Study of Metabolic Syndrome Use Omega-3 Fatty Acids and Low Fat Meal Replacements
Increased understanding of the impact of long chain omega-3 PUFAs in combination with a low fat plant-based diet will contribute to decelerating further escalation of the "epidemics" of obesity, the (pre)metabolic syndrome, and T2DM in Taiwan.
Read the detailed description
The metabolic syndrome is a common condition in which different degrees of hypertension, impaired glucose tolerance, atherogenic dyslipidemia, and central fat accumulation, as well as prothrombotic and proinflammatory states cluster together in the same individual. The modified National Cholesterol Education Program, Adult Treatment Panel III guidelines defined the metabolic syndrome subjects as individuals with 3 or more following criterion:
- Waist circumference: in male ≥90 cm and female ≥80 cm
- Raised triglycerides: > 150 mg/dL
- Reduced HDL cholesterol: <40 mg/dL in males, <50 mg/dL in females
- Raised blood pressure: systolic blood pressure >130 or diastolic blood pressure >85 mmHg
- Raised fasting plasma glucose: (FPG)>100 mg/dL
Changes in macronutrient composition have been used to promote weight loss and enhance insulin sensitivity, independent of an emphasis on overall calorie ingestion. Protective effects of fish intake on the development of insulin resistance has been reported in prospective epidemiological studies. Further, long chain omega-3 PUFAs supplementation may improve insulin sensitivity in patients with impaired glucose tolerance and in patients with T2DM.
However, this has not been clearly demonstrated in an intervention trial in Taiwan. Furthermore, the effect of supplementation of long chain omega-3 PUFAs on metabolic risk factors and insulin resistance, except for demonstrated benefit in terms of decreased triglycerides, needs further investigation among Asians.
This 13-week, randomized controlled study will assign approximately 200 subjects meeting criteria for the Metabolic Syndrome (50 each) to the following four arms 1) Standard Taiwan Diet plan; 2) Herbalife meal replacement diet program (Low fat diet); 3) Standard Taiwan Diet plan plus healthy oil supplement (Herbalifeline®) and 4) Herbalife meal replacement plan (Low fat diet) plus healthy oil supplement (Herbalifeline®). All participants will meet with a registered dietitian to assist them with their diet efforts.
In this study, we aim to study the effects of low fat diet with reduced omega-6 PUFAs alone and the same low fat diet with omega-3 fatty acids supplementation on cardiometabolic profile and circulating fatty acid profiles in subjects with the metabolic syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- fish oil capsule
- Keywords
- metabolic syndrome,, waist, blood pressure,, fasting plasma glucose,, HDL cholesterol,, triglycerides
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oil capsuleDietary supplement
500 mg of natural fish oil, made up of 30% omega-3 PUFA (EPA:DHA = 3:2)
| Study group | Role | What they receive |
|---|---|---|
| fish oil capsule | 10 capsules per day will provide 2130 mg of EPA (1280 mg) and DHA (850 mg) Receives: Dietary Supplement: fish oil capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome index
- Waist circumference in male ≥90 cm and female ≥80 cm
- Raised triglycerides: > 150 mg/dL
- Reduced HDL cholesterol: <40 mg/dL in males, <50 mg/dL in females
- Raised blood pressure: systolic blood pressure >130 or diastolic blood pressure >85 mmHg
- Raised fasting plasma glucose: (FPG)>100 mg/dL
Measured: Day 1 and up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionMar 2013 (estimated)
- Study completionJul 2013 (estimated)
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shih-Yi Huang, Ph.D, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768169
- Sponsor's protocol ID
- omega-3 fatty acids
- Status last verified
- Dec 2012
- First submitted
- 23 Dec 2012
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tang KY, Huang SY, Cheng TM, Bai CH, Chang JS. Haptoglobin phenotype influences the effectiveness of diet-induced weight loss in middle-age abdominally obese women with metabolic abnormalities. Clin Nutr. 2020 Jan;39(1):225-233. doi: 10.1016/j.clnu.2019.01.019. Epub 2019 Jan 26.
PubMed 30737047
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Metabolic Syndrome Use Omega-3 Fatty Acids and Low Fat Meal Replacements
- ClinicalTrials.gov ID
- NCT01768169
- Acronym / sponsor ID
- omega-3 fatty acids
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome,, waist, blood pressure,, fasting plasma glucose,, HDL cholesterol,, triglycerides
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 15 Jan 2013 (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.
Increased understanding of the impact of long chain omega-3 PUFAs in combination with a low fat plant-based diet will contribute to decelerating further escalation of the "epidemics" of obesity, the (pre)metabolic syndrome, and T2DM in Taiwan.
Detailed description
The metabolic syndrome is a common condition in which different degrees of hypertension, impaired glucose tolerance, atherogenic dyslipidemia, and central fat accumulation, as well as prothrombotic and proinflammatory states cluster together in the same individual. The modified National Cholesterol Education Program, Adult Treatment Panel III guidelines defined the metabolic syndrome subjects as individuals with 3 or more following criterion:
- Waist circumference: in male ≥90 cm and female ≥80 cm
- Raised triglycerides: > 150 mg/dL
- Reduced HDL cholesterol: <40 mg/dL in males, <50 mg/dL in females
- Raised blood pressure: systolic blood pressure >130 or diastolic blood pressure >85 mmHg
- Raised fasting plasma glucose: (FPG)>100 mg/dL
Changes in macronutrient composition have been used to promote weight loss and enhance insulin sensitivity, independent of an emphasis on overall calorie ingestion. Protective effects of fish intake on the development of insulin resistance has been reported in prospective epidemiological studies. Further, long chain omega-3 PUFAs supplementation may improve insulin sensitivity in patients with impaired glucose tolerance and in patients with T2DM.
However, this has not been clearly demonstrated in an intervention trial in Taiwan. Furthermore, the effect of supplementation of long chain omega-3 PUFAs on metabolic risk factors and insulin resistance, except for demonstrated benefit in terms of decreased triglycerides, needs further investigation among Asians.
This 13-week, randomized controlled study will assign approximately 200 subjects meeting criteria for the Metabolic Syndrome (50 each) to the following four arms 1) Standard Taiwan Diet plan; 2) Herbalife meal replacement diet program (Low fat diet); 3) Standard Taiwan Diet plan plus healthy oil supplement (Herbalifeline®) and 4) Herbalife meal replacement plan (Low fat diet) plus healthy oil supplement (Herbalifeline®). All participants will meet with a registered dietitian to assist them with their diet efforts.
In this study, we aim to study the effects of low fat diet with reduced omega-6 PUFAs alone and the same low fat diet with omega-3 fatty acids supplementation on cardiometabolic profile and circulating fatty acid profiles in subjects with the metabolic syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fish oil capsule | – | Dietary Supplement: fish oil capsule10 capsules per day will provide 2130 mg of EPA (1280 mg) and DHA (850 mg) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community sample, residents of Taiwan
Key inclusion criteria (9 listed)
- Age 30 to 65 years
- Female subjects must have a negative pregnancy test at screening, must be surgically sterile or at least 6 months postmenopausal or must use a form of birth control measure.
- BMI of 24 to 40 kg/m2 inclusive.
- Subjects must be in good health other than having metabolic syndrome as determined by medical history, physical examination, and screening clinical laboratory including chemistry panel and CBC.
- Must have stable smoking habits (or be now-smokers) for at least 6 months prior to screening and agree not to intend to change such habits during the course of the study.
Key exclusion criteria (12 listed)
- Diabetes
- nown or documented coronary heart disease (CHD) (including ECG consistent with prior myocardial infraction), cerebrovascular accident (including transient ischemic attack), peripheral vascular disease (including symptoms of claudication)
- Angina or other chest pain that may indicate CHD
- Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable)
- Known abnormal liver function tests greater than 3X upper limit of normal
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 |
|---|---|---|
| fish oil capsule500 mg of natural fish oil, made up of 30% omega-3 PUFA (EPA:DHA = 3:2) | Dietary supplement | fish oil capsule |
Primary outcome
Metabolic syndrome index
Time frame: Day 1 and up to 12 weeks
1. Waist circumference in male ≥90 cm and female ≥80 cm 2. Raised triglycerides: > 150 mg/dL 3. Reduced HDL cholesterol: <40 mg/dL in males, <50 mg/dL in females 4. Raised blood pressure: systolic blood pressure >130 or diastolic blood pressure >85 mmHg 5. Raised fasting plasma glucose: (FPG)>100 mg/dL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
- Derived from this study: PubMed 30737047Tang KY, Huang SY, Cheng TM, Bai CH, Chang JS. Haptoglobin phenotype influences the effectiveness of diet-induced weight loss in middle-age abdominally obese women with metabolic abnormalities. Clin Nutr. 2020 Jan;39(1):225-233. doi: 10.1016/j.clnu.2019.01.019. Epub 2019 Jan 26.
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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.
Shih-Yi Huang, Ph.D principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Taipei Medical University Hospital at 1 site in Taiwan.
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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 15 Jan 2013. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic syndrome index (time frame: Day 1 and up to 12 weeks). 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 NCT01768169, 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 15 Jan 2013.