The Effect of Omega-3 FA on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Patients

July 10, 2024 updated by: Jingjing Jiao, Zhejiang University

Double-blind and Placebo-controlled Study on Intervention Effect of n-3 Fatty Acids on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Populations

A double-blind and placebo-controlled study is conducted in the current human study.

The purpose of this study is to investigate the effects of n-3 PUFA intervention on glucose and lipid homeostasis in Chinese diabetic/obese patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approximately 450 diabetic and 450 obese patients will be enrolled from Lanxi in China. They will be randomly assigned into one of the following three groups: Omega-3 fatty acids capsules (1.5 g/d); or omega-3 fatty acids capsules (3 g/d); or placebo capsules. Blood, feces and urine samples will be collected before and after treatment. Glucose and lipid parameters will be measured. Diabetes comorbidities and complications will also be assessed. This study will also explore the new mechanisms of n-3 PUFAs on improving glucose and lipid homeostasis and other outcomes based on multi-omics and establish a model for precision intervention.

Study Type

Interventional

Enrollment (Actual)

415

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Jinhua, Zhejiang, China, 321102
        • Lanxi Red Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed type 2 diabetes for diabetic groups according to WHO diagnostic criteria;
  • BMI≥28 for obese groups;
  • Aged between 40 and 75 years.

Exclusion Criteria:

  • Type 1 diabetes;
  • Cardiovascular disease;
  • Cancer;
  • Liver or kidney disease;
  • Premenopausal women, pregnancy or lactation;
  • Allergy to fish;
  • Have participated in other clinical trials in the last three months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose group
Low-dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 1.5 grams per day for 1 year.
Drug: Low dose omega-3 fatty acid supplementation
Omega-3 fatty acids capsules, 1.5 g/d by mouth for 1 year
Other Names:
  • Fish oil supplement
Experimental: High dose group
High-dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 3 grams per day for 1 year.
Drug: High dose omega-3 fatty acid supplementation
Omega-3 fatty acids capsules, 3 g/d by mouth for 1 year
Other Names:
  • Fish oil supplement
Placebo Comparator: Control group
Control drug, matching placebo capsules, 3 grams per day for 1 year.
Drug: Control drug
Matching placebo capsules,3 g/d by mouth for 1 year
Other Names:
  • Placebo drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood glucose from baseline
Time Frame: 12 months
The investigators will measure HbA1c and fasting plasma glucose levels in blood samples before and after treatment.
12 months
Change in blood lipids from baseline
Time Frame: 12 months
The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.
12 months
Change in carotid plaque and carotid intima-meida thickness
Time Frame: 12 months
A FUJIFILM SonoSite ultrasound system will be used to assess carotid artery plaque lesions and measure carotid intima-media thickness (CIMT).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gut microbiota from baseline
Time Frame: 12 months
The investigators will collect faeces sample from every participants and 16S rDNA sequencing will be used to analyze the composition of gut microbiota.
12 months
Change in sleep quality
Time Frame: 12 months
The investigators will measure the Pittsburgh Sleep Quality Index (PSQI) through face-to-face questionnaire before and after treatment. The PSQI ranges from 0 to 21, with a higher score indicating a worse sleep quality.
12 months
Change in cognitive function
Time Frame: 12 months
The investigators will do the mini-mental state examination (MMSE) before and after treatment. The MMSE score ranges from 0 to 30, with higher scores indicative of superior cognitive functioning.
12 months
Change in bone mineral density (BMD)
Time Frame: 12 months
The whole body of the patient will be scanned and analyzed by a whole-body dual-energy X-ray absorptiometry (DXA) to measure the bone mineral density (BMD).
12 months
Change in body fat distribution
Time Frame: 12 months
The whole body of the patient will be scanned and analyzed by a whole-body dual-energy X-ray absorptiometry (DXA) to measure the total and regional body fat mass (FM) and then percentages of regional body fat will be calculated.
12 months
Change in urinary protein concentration
Time Frame: 12 months
The investigators will collect urine sample from every participant and measure urinary protein before and after treatment.
12 months
Change in estimated glomerular filtration rate (eGFR)
Time Frame: 12 months
The investigators will collect blood sample from every participant and measure blood creatinine before and after treatment. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation will be used to calculate the eGFR.
12 months
Change in blood metabolome
Time Frame: 12 months
The investigators will collect blood samples from every participant and the UPLC-MS/MS method will be used to analyze the blood metabolomics profile.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fecal metabolome
Time Frame: 12 months
The investigators will collect fecal samples from every participant and the UPLC-MS/MS method will be used to analyze the fecal metabolomics profile.
12 months
Change in urine metabolome
Time Frame: 12 months
The investigators will collect urine samples from every participant and the UPLC-MS/MS method will be used to analyze the urine metabolomics profile.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2020

Primary Completion (Actual)

January 2, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

October 14, 2018

First Submitted That Met QC Criteria

October 14, 2018

First Posted (Actual)

October 17, 2018

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT-N3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperlipidemias

Clinical Trials on High dose omega-3 fatty acid supplementation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe