NCT05295719

Brief Summary

The goal of this project is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and improve energy utilization and reduce inflammation and metabolic risk.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

December 14, 2021

Last Update Submit

September 4, 2025

Conditions

ObesityInflammationHuman MicrobiomeInsulin ResistanceDyslipidemias

Outcome Measures

Primary Outcomes (85)

  • Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 4 weeks

    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)

    Post-Supplementation at week 4

  • Mean Change from Baseline in Interleukin (IL)-6 at 4 weeks

    Interleukin (IL)-6 (pg/mL)

    Post-Supplementation at week 4

  • Mean Change from Baseline in Interleukin (IL)-10 at 4 weeks

    Interleukin (IL)-10 (pg/mL)

    Post-Supplementation at week 4

  • Mean Change from Baseline in Monocyte chemoattractant protein-1 at 4 weeks

    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)

    Post-Supplementation at week 4

  • Mean Change from Baseline in Tumor necrosis factor at 4 weeks

    Tumor necrosis factor (TNF)-alpha (pg/mL)

    Post-Supplementation at week 4

  • Mean Change from Baseline in Total Cholesterol at 4 weeks

    Total cholesterol (mg/dL)

    Post-Supplementation at week 4

  • Mean Change from Baseline in High-density lipoprotein (HDL)at 4 weeks

    High-density lipoprotein (HDL) (mg/dL)

    Post-Supplementation at week 4

  • Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 4 weeks

    Non-high-density lipoprotein (Non-HDL) (mg/dL)

    Post-Supplementation at week 4

  • Mean Change from Baseline in Low-density lipoprotein (LDL) at 4 weeks

    Low-density lipoprotein (LDL) (mg/dL)

    Post-Supplementation at week 4

  • Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 4 weeks

    Very-low-density lipoprotein (VLDL) (mg/dL)

    Post-Supplementation at week 4

  • Mean Change from Baseline in Triglycerides at 4 weeks

    Triglycerides (mg/dL).

    Post-Supplementation at week 4

  • Mean Change from Baseline in Total/HDL cholesterol at 4 weeks

    Total/HDL cholesterol (mg/dL)

    Post-Supplementation at week 4

  • Mean Change from Baseline in Fasting blood glucose at 4 weeks

    Fasting blood glucose (mg/dL)

    Post-supplementation at week 4

  • Mean Change from Baseline in Insulin at 4 weeks

    Insulin (μU/mL)

    Post-supplementation at week 4

  • Mean Change from Baseline in Total Body Fat Percentage at 4 weeks

    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.

    Post-Supplementation at week 4

  • Mean Change from Baseline in Body Weight at 4 weeks

    Body weight (kilograms)

    Post-Supplementation at week 4

  • Mean Change from Baseline in Skeletal Muscle Mass Percentage at 4 weeks

    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.

    Post-Supplementation at week 4

  • Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 8 weeks

    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)

    Post-Intervention at week 8

  • Mean Change from Baseline in Monocyte chemoattractant protein-1 at 8 weeks

    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)

    Post-Intervention at week 8

  • Mean Change from Baseline in Interleukin (IL)-6 at 8 weeks

    Interleukin (IL)-6 (pg/mL)

    Post-Intervention at week 8

  • Mean Change from Baseline in Interleukin (IL)-10 at 8 weeks

    Interleukin (IL)-10 (pg/mL)

    Post-Intervention at week 8

  • Mean Change from Baseline in Tumor necrosis factor (TNF) at 8 weeks

    Tumor necrosis factor (TNF)-alpha (pg/mL)

    Post-Intervention at week 8

  • Mean Change from Baseline in Total Cholesterol at 8 weeks

    Total Cholesterol (mg/dL)

    Post-Intervention at week 8

  • Mean Change from Baseline in High-density lipoprotein (HDL) at 8 weeks

    High-density lipoprotein (HDL) (mg/dL)

    Post-Intervention at week 8

  • Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 8 weeks

    Non-high-density lipoprotein (Non-HDL) (mg/dL)

    Post-intervention at week 8

  • Mean Change from Baseline in Low-density lipoprotein (LDL) at 8 weeks

    Low-density lipoprotein (LDL) (mg/dL)

    Post-Intervention at week 8

  • Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 8 weeks

    Very-low-density lipoprotein (VLDL) (mg/dL)

    Post-Intervention at week 8

  • Mean Change from Baseline in Triglycerides at 8 weeks

    Triglycerides (mg/dL).

    Post-Intervention at week 8

  • Mean Change from Baseline in total/HDL cholesterol at 8 weeks

    Total/HDL cholesterol (mg/dL)

    Post-Intervention at week 8

  • Mean Change from Baseline in Fasting blood glucose at 8 weeks

    Fasting blood glucose (mg/dL)

    Post-Intervention at week 8

  • Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 8 weeks

    Oral glucose tolerance test (OGTT). Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.

    Post-Intervention at week 8

  • Mean Change from Baseline in Insulin at 8 weeks

    Insulin (μU/mL)

    Post-Intervention at week 8

  • Mean Change from Baseline in Body Weight at 8 weeks

    Body weight (kilograms)

    Post-Intervention at week 8

  • Mean Change from Baseline in Total Body Fat Percentage at 8 weeks

    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.

    Post-Intervention at week 8

  • Mean Change from Baseline in Skeletal Muscle Mass Percentage at 8 weeks

    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.

    Post-Intervention at week 8

  • Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 10 weeks

    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)

    Post-Detraining at week 10

  • Mean Change from Baseline in Interleukin (IL)-6 at 10 weeks

    Interleukin (IL)-6 (pg/mL)

    Post-Detraining at week 10

  • Mean Change from Baseline in Interleukin (IL)-10 at 10 weeks

    Interleukin (IL)-10 (pg/mL)

    Post-Detraining at week 10

  • Mean Change from Baseline in Tumor necrosis factor (TNF) at 10 weeks

    Tumor necrosis factor (TNF)-alpha (pg/mL)

    Post-Detraining at week 10

  • Mean Change from Baseline in Monocyte chemoattractant protein-1 at 10 weeks

    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)

    Post-Detraining at week 10

  • Mean Change from Baseline in Total Cholesterol at 10 weeks

    Total Cholesterol (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Baseline in High-density lipoprotein (HDL) at 10 weeks

    High-density lipoprotein (HDL) (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 10 weeks

    Non-high-density lipoprotein (Non-HDL) (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Baseline in Low-density lipoprotein (LDL) at 10 weeks

    Low-density lipoprotein (LDL)(mg/dL)

    Post-Detraining at week 10

  • Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 10 weeks

    Very-low-density lipoprotein (VLDL) (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Baseline in Total/HDL cholesterol at 10 weeks

    Total/HDL cholesterol (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Baseline in Triglycerides at 10 weeks

    Triglycerides (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Baseline in Insulin at 10 weeks

    Insulin (μU/mL)

    Post-Detraining at week 10

  • Mean Change from Baseline in Fasting blood glucose at 10 weeks

    Fasting blood glucose (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Baseline in Skeletal Muscle Mass Percentage at 10 weeks

    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.

    Post-Detraining at week 10

  • Mean Change from Baseline in Body weight at 10 weeks

    Body weight (kilograms)

    Post-Detraining at week 10

  • Mean Change from Baseline in Total Body Fat Percentage at 10 weeks

    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.

    Post-Detraining at week 10

  • Mean Change from Post-Supplementation in Serum high-sensitivity C-reactive protein at 8 weeks

    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in Interleukin (IL)-6 at 8 weeks

    Interleukin (IL)-6 (pg/mL)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in Interleukin (IL)-10 at 8 weeks

    Interleukin (IL)-10 (pg/mL)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in Monocyte chemoattractant protein-1 at 8 weeks

    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in Tumor necrosis factor (TNF) at 8 weeks

    Tumor necrosis factor (TNF)-alpha (pg/mL)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in Total Cholesterol at 8 weeks

    Total Cholesterol (mg/dL)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in Total/HDL cholesterol at 8 weeks

    Total/HDL cholesterol (mg/dL)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in High-density lipoprotein (HDL) at 8 weeks

    High-density lipoprotein (HDL) (mg/dL)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in Non-high-density lipoprotein (Non-HDL) at 8 weeks

    Non-high-density lipoprotein (Non-HDL) (mg/dL)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in Low-density lipoprotein (LDL) at 8 weeks

    Low-density lipoprotein (LDL) (mg/dL)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in Very-low-density lipoprotein (VLDL) at 8 weeks

    Very-low-density lipoprotein (VLDL) (mg/dL)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in Triglycerides at 8 weeks

    Triglycerides (mg/dL)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in Insulin at 8 weeks

    Insulin (μU/mL)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in Fasting blood glucose at 8 weeks

    Fasting blood glucose (mg/dL)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in Body weight at 8 weeks

    Body weight (kilograms)

    Post-Intervention at week 8

  • Mean Change from Post-Supplementation in Total Body Fat Percentage at 8 weeks

    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.

    Post-Intervention at week 8

  • Mean Change from Post-Intervention in Serum high-sensitivity C-reactive protein at 10 weeks

    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Tumor Necrosis Factor (TNF) at 10 weeks

    Tumor necrosis factor (TNF)-alpha (pg/mL)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Interleukin (IL)-6 at 10 weeks

    Interleukin (IL)-6 (pg/mL)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Interleukin (IL)-10 at 10 weeks

    Interleukin (IL)-10 (pg/mL)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Monocyte Chemoattractant Protein-1 at 10 weeks

    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Total Cholesterol at 10 weeks

    Total Cholesterol (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in High-density lipoprotein (HDL) at 10 weeks

    High-density lipoprotein (HDL) (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Non-high-density lipoprotein (Non-HDL) at 10 weeks

    Non-high-density lipoprotein (Non-HDL) (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Low-density lipoprotein (LDL) at 10 weeks

    Low-density lipoprotein (LDL) (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Very-low-density lipoprotein (VLDL) at 10 weeks

    Very-low-density lipoprotein (VLDL) (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Total/HDL cholesterol at 10 weeks

    Total/HDL cholesterol (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Triglycerides at 10 weeks

    Triglycerides (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Insulin at 10 weeks

    Insulin (μU/mL)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Fasting blood glucose at 10 weeks

    Fasting blood glucose (mg/dL)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Body weight at 10 weeks

    Body weight (kilograms)

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Total Body Fat Percentage at 10 weeks

    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.

    Post-Detraining at week 10

  • Mean Change from Post-Intervention in Skeletal Muscle Mass Percentage at 10 weeks

    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.

    Post-Detraining at week 10

Secondary Outcomes (35)

  • Mean Change from Baseline in Bacterial Profile at 4 weeks

    Post-Supplementation at week 4

  • Mean Change from Baseline in Serum Acetate Profile at 4 weeks

    Post-Supplementation at week 4

  • Mean Change from Baseline in Fecal acetate Profile at 4 weeks

    Post-Supplementation at week 4

  • Mean Change from Baseline in Propionate Profile at 4 weeks

    Post-Supplementation at week 4

  • Mean Change from Baseline in Butyrate Profile at 4 weeks

    Post-Supplementation at week 4

  • +30 more secondary outcomes

Study Arms (4)

Placebo & Flexibility Training (Control)

PLACEBO COMPARATOR

Subjects will take placebo (safflower oil, AlaskOmega®) for an initial supplementation period of 4 weeks. Participants will continue supplementation and will also engage in low-intensity training (control group) for 30 minutes 3 times/week for 4 weeks. All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will continue supplementation and will cease low-intensity training for a 2 week follow-up period.

Dietary Supplement: Safflower oilBehavioral: Low-intensity training

Placebo & High-Intensity Interval Training

ACTIVE COMPARATOR

Subjects will take placebo (safflower oil, AlaskOmega®) for an initial supplementation period of 4 weeks. Participants will continue supplementation and will also engage in a 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 4 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max . All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will continue supplementation and cease HIIT training for a 2 week follow-up period.

Behavioral: High-Intensity Interval TrainingDietary Supplement: Safflower oil

n-3 PUFA & Flexibility Training (Control)

ACTIVE COMPARATOR

Subjects will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) for an initial supplementation period of 4 weeks. Participants will continue supplementation and will also engage in low-intensity training (control group) for 30 minutes 3 times/week for 4 weeks. All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will continue supplementation and cease low-intensity training for a 2 week follow-up period.

Dietary Supplement: Omega-3 polyunsaturated fatty acidBehavioral: Low-intensity training

n-3 PUFA & High-Intensity Interval Training

EXPERIMENTAL

Subjects will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) for an initial supplementation period of 4 weeks. Participants will continue supplementation and will also engage in a 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 4 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max . All exercise sessions will be performed on a stationary bike and conducted under investigator supervision. Participants will continue supplementation and cease low-intensity training for a 2 week follow-up period.

Dietary Supplement: Omega-3 polyunsaturated fatty acidBehavioral: High-Intensity Interval Training

Interventions

Omega-3 polyunsaturated fatty acidDIETARY_SUPPLEMENT

4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA)

Also known as: AlaskOmega
n-3 PUFA & Flexibility Training (Control)n-3 PUFA & High-Intensity Interval Training
High-Intensity Interval TrainingBEHAVIORAL

A 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 4 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max.

Also known as: HIIT
Placebo & High-Intensity Interval Trainingn-3 PUFA & High-Intensity Interval Training
Safflower oilDIETARY_SUPPLEMENT

4 grams safflower oil (AlaskOmega®) per day

Also known as: Placebo
Placebo & Flexibility Training (Control)Placebo & High-Intensity Interval Training
Low-intensity trainingBEHAVIORAL

A low-intensity training exercise program 3 days/week for 4 weeks. This will include consistently cycling at 50% HRmax for 30 min.

Placebo & Flexibility Training (Control)n-3 PUFA & Flexibility Training (Control)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Overweight/ Obese (BMI ≥ 25 to ≤ 40 kg/m2)
  • Elevated Triglycerides (\>150 mg/dL)
  • Prediabetes (fasting blood glucose 100 to 125 mg/dl)

You may not qualify if:

  • Diagnosed with Diabetes or liver disease.
  • Taking BP or diabetes medications.
  • Received antibiotics medications in the last 6 months.
  • Pregnant/ lactating/ Irregular menstrual cycle/ menopausal.
  • Currently following a formal/ structured weight loss program.
  • Currently taking fish oil.
  • Do not have access to smart phone/ computer with internet access.
  • Exercise ≥ 1 time/week or a moderate-high score on the International Physical Activity Questionnaire.
  • Feeling uncomfortable riding bike for 30 minutes.
  • Claustrophobic or unable to stay under the hood for metabolic testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech Kinesiology Building

Lubbock, Texas, 79406, United States

Location

MeSH Terms

Conditions

ObesityInflammationInsulin ResistanceDyslipidemias

Interventions

Docosahexaenoic AcidsHigh-Intensity Interval TrainingSafflower Oil

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaFats, UnsaturatedPlant OilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Kembra D Albracht-Schulte, Ph.D

    Texas Tech University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 14, 2021

First Posted

March 25, 2022

Study Start

September 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)