Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-01 @ 7:28 PM
Study NCT ID:
NCT01768169
Status:
UNKNOWN
Last Update Posted:
2013-01-15
First Post:
2012-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Metabolic Syndrome Use Omega-3 Fatty Acids and Low Fat Meal
Sponsor:
Taipei Medical University Hospital
Organization:
Study Overview
Official Title:
Phase 2 Study of Metabolic Syndrome Use Omega-3 Fatty Acids and Low Fat Meal Replacements
Status:
UNKNOWN
Status Verified Date:
2012-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: