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Omega-3 Fatty Acids
Fish Oil for Cold Exposure
N/A
Recruiting
Led By Timothy D Mickleborough, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 125 minutes
Awards & highlights
Study Summary
This trial will look at if fish oil helps people stay warm and comfortable in cold temperatures.
Who is the study for?
This trial is for active men and women aged 18-40 with a BMI of 18.5 to 24.9, who don't smoke or have bleeding disorders, immune/autoimmune diseases, metabolic or heart disease, hypertension, renal or neurological issues. They shouldn't be taking SSRIs, ADHD meds, painkillers regularly; consume fish oil supplements or more than one fish meal weekly; have rectal disorders; be pregnant; or have high blood pressure/pulse rate.Check my eligibility
What is being tested?
The study tests if fish oil supplements can influence brown fat activity and the body's response to cold exposure compared to a placebo. Participants will experience cold conditions while their shivering responses, thermal comfort levels and skin blood flow are monitored.See study design
What are the potential side effects?
Fish oil may cause minor side effects like nausea, belching with a fishy taste in the mouth, bloating and diarrhea. It might also increase bleeding time in people prone to bleeding disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 125 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~125 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
24 Hour Dietary Recalls
Cold Chamber Challenge
Core Temperature
+8 moreSecondary outcome measures
Blood Pressure
Body Fat Percentage
Bone Mineral Density
+5 moreSide effects data
From 2007 Phase 1 & 2 trial • 39 Patients • NCT0009040215%
Dizziness
15%
cold
8%
Falls
8%
Heart Failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fish Oil
Fish Oil Plus Lipoic Acid
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fish Oil (Omega-3 Fatty Acids)Experimental Treatment1 Intervention
15 subjects will ingest 6 capsules of fish oil of per day for 12 weeks
Group II: Olive OilPlacebo Group1 Intervention
15 subjects will ingest 6 capsules of olive oil per day for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fish Oil
2006
Completed Phase 4
~1370
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
981,732 Total Patients Enrolled
Timothy D Mickleborough, PhDPrincipal InvestigatorIndiana University
3 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of problems with bleeding or blood clotting.You have a history of smoking or using tobacco products.You have a history of high cholesterol.Your body mass index (BMI) falls within the healthy range of 18.5 to 24.9 kg/m2.You have or had a condition that weakens your immune system or causes autoimmune disease.You have a history of a disease that affects your metabolism.You are physically active according to the International Physical Activity Questionnaire (IPAQ) and the Physical Activity Readiness Questionnaire (PAR-Q+).You have a history of high blood pressure or heart problems.You have had kidney problems in the past.You have a history of brain or nerve-related conditions.You are currently taking antidepressants, anxiety medication, medication for attention deficit disorder (ADD/ADHD), or regularly using pain medication like Aleve, Tylenol, or CBD.You regularly take fish oil supplements or eat fish more than once a week.You have a past diagnosis of diabetes.You are eating more than one fish meal per week during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Fish Oil (Omega-3 Fatty Acids)
- Group 2: Olive Oil
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are those aged 55 or older eligible to be participants in this experiment?
"This clinical trial is enrolling participants aged 18 and above, but younger than 40 years."
Answered by AI
Are new participants being accepted into this experiment?
"Clinicaltrials.gov has verified that patient recruitment for this medical study is currently in progress, it was published on June 12th 2023 and the most recent edit occurred on July 24th 2023."
Answered by AI
How many participants are being monitored for this clinical research?
"Affirmative. Online records available on clinicaltrials.gov provide evidence that this medical trial is actively searching for volunteers; it was first posted in June 12th 2023 and the most recent update being July 24th 2023. The study requires 30 people to be recruited from one site."
Answered by AI
What is the desired outcome of this investigation?
"The primary metric evaluated over the 12 week period is Minnesota Manual Dexterity Test (MMDT). Secondary outcomes of this study are Pulse Rate, Bone Mineral Density and Body Fat Percentage. All three will be measured by way of Dual Energy X-Ray Absorptiometry (DEXA) procedures for accuracy."
Answered by AI
Who is eligible to partake in this clinical research?
"30 individuals between 18 and 40 years of age, whose BMI is within the range of 18.5 to 24.9 kg/m2, are sought for enrollment in this trial. Additionally, participants must have a medium-high level of activity as measured by IPAQ and PAR-Q+."
Answered by AI
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