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

NCT01768169 | Unknown DMC

• 1 other identifier: omega-3 fatty acids
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome,; waist, blood pressure,; fasting plasma glucose,; HDL cholesterol,; triglycerides

Outcome Measures

Primary Outcomes (1)

• Metabolic syndrome index

  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

  Day 1 and up to 12 weeks

Study Arms (1)

fish oil capsule

10 capsules per day will provide 2130 mg of EPA (1280 mg) and DHA (850 mg)

Dietary Supplement: fish oil capsule

Interventions

fish oil capsule DIETARY_SUPPLEMENT

500 mg of natural fish oil, made up of 30% omega-3 PUFA (EPA:DHA = 3:2)

fish oil capsule

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

community sample, residents of Taiwan

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Mecical University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 30737047 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Shih-Yi Huang, Ph.D

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2012
• First Posted: January 15, 2013
• Study Start: April 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 15, 2013

Record last verified: 2012-12

Locations

TW (1)