Study of Metabolic Syndrome Use Omega-3 Fatty Acids and Low Fat Meal

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Taipei Medical University Hospital
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01768169
First received: December 23, 2012
Last updated: January 11, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Dietary Supplement: fish oil capsule

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 2 Study of Metabolic Syndrome Use Omega-3 Fatty Acids and Low Fat Meal Replacements

Resource links provided by NLM:


Further study details as provided by Taipei Medical University Hospital:

Primary Outcome Measures:
  • Metabolic syndrome index [ Time Frame: Day 1 and up to 12 weeks ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
fish oil capsule
10 capsules per day will provide 2130 mg of EPA (1280 mg) and DHA (850 mg)
Dietary Supplement: fish oil capsule
500 mg of natural fish oil, made up of 30% omega-3 PUFA (EPA:DHA = 3:2)

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:

  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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

community sample, residents of Taiwan

Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768169

Locations
Taiwan
Taipei Mecical University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Wen-Yi Cheng    886223711458    rhoda2891@hotmail.com   
Principal Investigator: Shih-Yi Huang, Ph.D.         
Sub-Investigator: Hsiu-Yue Su, MSc         
Sub-Investigator: Chien-Tien Su, Ph.D         
Sponsors and Collaborators
Taipei Medical University Hospital
Investigators
Principal Investigator: Shih-Yi Huang, Ph.D Taipei Medical University
  More Information

No publications provided

Responsible Party: Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT01768169     History of Changes
Other Study ID Numbers: omega-3 fatty acids
Study First Received: December 23, 2012
Last Updated: January 11, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taipei Medical University Hospital:
metabolic syndrome,
waist, blood pressure,
fasting plasma glucose,
HDL cholesterol,
triglycerides

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014