Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults

Sponsor
May Faraj, PDt, PhD
Study ID
NCT07575438
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Obesity & Overweight
  • Obesity and Diabetes Mellitus, Type 2
  • Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
  • Prediabetes / Type 2 Diabetes
  • Type 2 Diabetes

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Fish Oil — DIETARY_SUPPLEMENT
    Four softgels of Carlson Elite EPA Gems taken orally per day (NPN 80079735, 1 g EPA/softgel)
  • Fish Oil — DIETARY_SUPPLEMENT
    Four softgels of Carlson Elite DHA Gems taken orally per day (NPN 80079736, 1 g DHA/softgel)
  • Corn oil control — DIETARY_SUPPLEMENT
    Four softgels of Carlson placebo taken orally per day (food-grade corn oil, 0 g EPA and DHA per softgel)

Study Details

The purpose of this clinical trial is to find out whether one type of fish oil works better than another at improving metabolic health in people who are at high risk of developing type 2 diabetes. Some metabolic problems-such as difficulty controlling blood sugar, unhealthy particles that transport cholesterol in the blood, and poor fat tissue function-can increase the risk of type 2 diabetes. This study aims to determine whether different types of fish oil can: 1. Improve how well the body produces insulin and responds to it, 2. Improve the quality of the particles that carry "bad" cholesterol in the blood, and 3) Improve the health and function of participants' fat tissue. To answer these questions, researchers will compare the effects of two types of fish oil: EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). These will be compared with corn oil, which is used as a placebo and does not contain EPA or DHA. When included in this study, participants will: A) Take softgel capsules containing EPA, DHA, or placebo (corn oil) every day for 12 weeks, B) Keep a daily log to record when they take their study softgels, and C) Visit the research unit six times, including one and a half days before and after the intervention, to complete specialized metabolic tests that are mostly only available in research settings.

Key Dates

First listed
May 8, 2026
Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Eicosapentaenoic acid (EPA)
    4 g EPA per day
  • Active Comparator: Docosahexaenoic acid (DHA)
    4 g DHA per day
  • Placebo Comparator: Corn oil
    0 g EPA and DHA per day

Primary Outcome Measure

Change from baseline to 12 weeks in the disposition index [ Time Frame: 12-weeks ]

Central Contacts

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