ObesityNCT05297383
Combining HIIT and n-3 PUFA Supplementation to Reduce Inflammation and Improve Metabolic Health (HIIT&PUFA)
A study testing Omega-3 Polyunsaturated Fatty Acid., Safflower Oil and High-Intensity Interval Training in people with Obesity and Inflammation, run by Texas Tech University.
Trial summary
The goal of this pilot study is to understand the combined effects of fish oil and exercise in obesity-associated inflammation acutely. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and reduce inflammation and metabolic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Inflammation, Insulin Resistance
- What is being tested?
- Omega-3 Polyunsaturated Fatty Acid., Safflower Oil and High-Intensity Interval Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old.
- Overweight/ Obese.
- Elevated Triglycerides.
- Fasting blood glucose < 126 mg/dL
Who cannot join
- Diagnosed with diabetes, liver disease, or any lower gastrointestinal disease.
- Currently taking blood pressure, diabetes, or lipid lowering medication.
- Received antibiotic treatment within the last 6 months.
- Are pregnant, lactating, have an irregular menstrual cycle, or are menopausal.
- Currently following a structured or formal weight loss program.
- Exercise ≥ 1 time/week or a moderate-high score on the International Physical Activity Questionnaire.
Show all 9Show fewer
- Currently taking fish oil supplements (within 4 weeks prior to participant randomization) or eat ≥1 fatty fish meal/week.
- Do not have access to a smartphone.
- Feel uncomfortable riding a stationary bike for 30 minutes.
About this study
Official title: Pilot: Combining Fish Oil and Exercise to Improve Obesity-Associated Inflammation
The goal of this pilot study is to understand the combined effects of fish oil and exercise in obesity-associated inflammation acutely. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and reduce inflammation and metabolic risk.
Read the detailed description
Incidence of obesity continues to increase in the United States and worldwide, making its prevention or reduction a public health priority. Nutrition research that can lead to effective prevention strategies is greatly needed. Inflammation is a major underlying cause for obesity, and it is imperative that we understand how anti-inflammatory food sources, such as fish oil, could aid in reducing obesity. Moreover, exercise is effective at reducing systemic inflammation and improving insulin resistance. Both exercise and diet can influence health through changes in the gut microbiome; however, no studies have investigated how together these affect gut microbiome and overall metabolic health. The goal 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 reduce inflammation and metabolic risk. This study will provide the foundation for development of novel strategies for obesity, inflammation, dyslipidemia and dysglycemia.
Aim 1: Determine combined effects of n-3 PUFA and HIIT on improving metabolic risk:
The investigators will test the hypothesis that n-3 PUFA in addition to HIIT will have beneficial effects on obesity-related markers of inflammation, dyslipidemia and insulin resistance in placebo, n-3 or exercise alone, and combined n-3 and exercise.
Aim 1.1: Investigate the influence of n-3 PUFA and HIIT on body weight and composition:
At baseline (week 0), anthropometric assessments will be performed, including: (1) height (m); (2) weight (kg); (3) waist circumference (cm); (4) hip circumference (cm); and body composition which will be assessed utilizing dual-energy X-ray absorptiometry (DXA) scanning. Anthropometric measures will be repeated at post-intervention (week 6).
Aim 1.2: Investigate the influence of n-3 PUFA and HIIT on serum markers associated with obesity
Fasting blood samples collected at weeks 1 and 6 will be analyzed for (1) markers of inflammation, including high sensitivity C-reactive protein (hs-CRP), IL-6, IL-10, MCP-1, and TNF-α; (2) adipokines, including adiponectin, resistin, and leptin; and (3) indices of systemic insulin resistance, including insulin and fasting blood glucose and (4) indices of dyslipidemia, including total cholesterol, high-density, lipoprotein (HDL), non-HDL, low- and very low-density lipoproteins (LDL and VLDL), total/HDL cholesterol, and triglycerides (TG) utilizing ELISA kits or Luminex analyzer [1] in the Nutrition, Exercise, \& Translational (NExT) Medicine Lab in the Department of Kinesiology \& Sport Management, TTU, Lubbock.
Aim 2: Determine combined effects of n-3 PUFA and HIIT on improving gut dysbiosis:
The investigators will test the hypothesis that n-3 PUFA supplementation will improve gut microbiota composition and related metabolites, which will result in reduced inflammation and ameliorate the metabolic response to a HIIT exercise intervention in an overweight population. This will be accomplished by identifying alterations in gut microbiota profiles following n-3 supplementation, HIIT or the interactive effects of both HIIT and n-3 PUFA.
Aim 2.1: Investigate the influence of n-3 PUFA and exercise on gut microbiota composition
Fecal samples will be collected by participants at their convenience in their homes and less than 24 hours prior to visiting the lab. Samples will be brought to the lab at weeks 1 and 6. Samples will be collected at home with investigator prepared kits and will be stored at -80°C until DNA extraction. Metagenomics analyses will be conducted in consultation with our collaborators at the University of Houston.
Aim 2.2: Investigate the influence of n-3 PUFA and exercise on microbiota produced metabolites
Fecal and serum short-chain fatty acid (SCFA)s, including acetate, propionate and butyrate, will be measured as markers of the above gut bacteria changes and in association with changes in serum markers of inflammation, dyslipidemia and dysglycemia. Fecal and serum SCFAs will be measured utilizing gas chromatography. Analyses will be conducted on fasting blood samples collected at baseline and post-intervention.
Participants will be randomly allocated to 1 of 4 treatment groups (n = 120), each balanced for sex, BMI, lipid profile, and dietary intake.
- placebo (safflower oil, AlaskOmega®) + flexibility (exercise control)
- n-3 PUFA (4 grams, 3000 mg EPA and 1000 mg DHA, AlaskOmega®) + flexibility training (exercise control)
- placebo (safflower oil, AlaskOmega®) + HIIT
- n-3 PUFA + HIIT
The goal is to conduct the study in smaller cohorts, such as 10-15 participants/group (n = 40-60).
4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) will be taken by participants in n-3 PUFA groups for 6 weeks
Placebo (safflower oil, AlaskOmega®, from Organic Technologies Inc.) will be taken by participants in placebo groups for 6 weeks
A 4 x 4 HIIT exercise (4 intervals for 4 min at 85-95% HRmax with 3min active recovery at 50-70% HRmax) program, 3 days/week, conducted under virtual investigator supervision and utilizing cycle ergometers (Keiser M3i Indoor Bike) equipment in collaboration with the TTU Department of Kinesiology \& Sport Management for 6 weeks.
If not asked to exercise, participants will be instructed to maintain their normal level of physical activity but will participate in time-matched control consisting of flexibility training led by investigators for 6 weeks.
All participants will wear a heart rate monitor (Polar H10) provided by TTU throughout the training (HIIT and control) to monitor exertion level.
Capsules will be administered in a double-blind fashion and will be identical in appearance. To ensure compliance, subjects will be reminded via phone (text message or phone call based on participant preference) to take their capsules and counts will be conducted when they come in for study visits.
At the end of the 6-week study, assessments will be repeated.
- Conditions
- Obesity, Inflammation, Insulin Resistance, Dyslipidemias, Gut Microbiome
- Being tested
- Omega-3 Polyunsaturated Fatty Acid., Safflower Oil, High-Intensity Interval Training, Flexibility Training
- Medical subject headings
- Obesity, Inflammation, Insulin Resistance, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Polyunsaturated Fatty Acid.Dietary supplement
Also called AlaskOmega
4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA).
Safflower OilDietary supplement
Also called Placebo
4 grams safflower oil (AlaskOmega®) per day.
High-Intensity Interval TrainingBehavioural
Also called HIIT
A 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 6 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.
Flexibility TrainingBehavioural
Also called Flexibility
30 min of stretching 3 days/week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| n-3 PUFA and flexibility- Control | Active comparator | Participants will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) for 6 weeks. Alongside supplementation, participants will be instructed to maintain their normal level of physical activity but will participate in a time-matched control consisting of flexibility training (low-intensity exercise) for 6 weeks. Receives: Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid.; Behavioral: Flexibility Training |
| Placebo and flexibility- Control | Placebo comparator | Participants will take Placebo (safflower oil, AlaskOmega®, from Organic Technologies Inc.) will be taken by participants in placebo groups for 6 weeks. Alongside supplementation, participants will be instructed to maintain their normal level of physical activity but will participate in a time-matched control consisting of flexibility training (low-intensity exercise) for 6 weeks. Receives: Dietary Supplement: Safflower Oil; Behavioral: Flexibility Training |
| n-3 PUFA and HIIT- Test | Active comparator | Participants will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) for 6 weeks. Alongside supplementation, participants will engage in a 4 x 4 HIIT exercise (4 intervals for 4 min at 85-95% HRmax with 3min active recovery at 50-70% HRmax) program, 3 days/week, for 6 weeks. Receives: Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid.; Behavioral: High-Intensity Interval Training |
| Placebo and HIIT- Test | Placebo comparator | Participants will take Placebo (safflower oil, AlaskOmega®, from Organic Technologies Inc.) will be taken by participants in placebo groups for 6 weeks. Alongside supplementation, participants will engage in a 4 x 4 HIIT exercise (4 intervals for 4 min at 85-95% HRmax with 3min active recovery at 50-70% HRmax) program, 3 days/week, for 6 weeks. Receives: Dietary Supplement: Safflower Oil; Behavioral: High-Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 6 weeks
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Measured: Baseline and 6 weeks
Mean Change from Baseline in Interleukin (IL)-6 at 6 weeks
Interleukin (IL)-6 (pg/mL)
Measured: Baseline and 6 weeks
Mean Change from Baseline in Interleukin (IL)-10 at 6 weeks
Interleukin (IL)-10 (pg/mL)
Measured: Baseline and 6 weeks
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 6 weeks
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Measured: Baseline and 6 weeks
Mean Change from Baseline in Tumor necrosis factor at 6 weeks
Tumor necrosis factor (TNF)-alpha (pg/mL)
Measured: Baseline and 6 weeks
Mean Change from Baseline in High-density lipoprotein (HDL) at 6 weeks
High-density lipoprotein (HDL) (mg/dL)
Measured: Baseline and 6 weeks
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 6 weeks
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Measured: Baseline and 6 weeks
Mean Change from Baseline in Low-density lipoprotein (LDL) at 6 weeks
Low-density lipoprotein (LDL) (mg/dL)
Measured: Baseline and 6 weeks
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 6 weeks
Very-low-density lipoprotein (VLDL) (mg/dL)
Measured: Baseline and 6 weeks
Mean Change from Baseline in Triglycerides at 6 weeks
Triglycerides (mg/dL).
Measured: Baseline and 6 weeks
Mean Change from Baseline in Total/HDL cholesterol at 6 weeks
Total/HDL cholesterol (mg/dL)
Measured: Baseline and 6 weeks
Mean Change from Baseline in Total cholesterol (mg/dL) at 6 weeks
Total cholesterol (mg/dL)
Measured: Baseline and 6 weeks
Mean Change from Baseline in Insulin at 6 weeks
Insulin (μU/mL)
Measured: Baseline and 6 weeks
Mean Change from Baseline in Fasting blood glucose at 6 weeks
Fasting blood glucose (mg/dL)
Measured: Baseline and 6 weeks
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 6 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.
Measured: Baseline and 6 weeks
Mean Change from Baseline in Total Body Fat Percentage at 6 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.
Measured: Baseline and 6 weeks
Mean Change from Baseline in Cardio Respiratory Fitness at week 0
VO2 Max (mL/kg/min)
Measured: Baseline and 6 weeks
Secondary outcomes (4)
Mean Change from Baseline in Bacterial Profile at 6 weeks
Fecal Microbial DNA (16s Sequencing)
Measured: Baseline and 6 weeks
Mean Change from Baseline in Serum Acetate Profile at 6 weeks
Serum Acetate (SCFA: gas chromatography analysis)
Measured: Baseline and 6 weeks
Mean Change from Baseline in Propionate Profile at 6 weeks
Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Baseline and 6 weeks
Mean Change from Baseline in Butyrate Profile at 6 weeks
Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston, Texas Tech University Health Sciences Center
- Responsible party
- Principal investigator, Kembra Albracht, Texas Tech University
- Investigators
- Kembra KA Albracht-Schulte, Ph.D., Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297383
- Sponsor's protocol ID
- 2019-07195-P
- Other IDs
- 2019
- Status last verified
- Sep 2025
- First submitted
- 15 Mar 2022
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot: Combining Fish Oil and Exercise to Improve Obesity-Associated Inflammation
- ClinicalTrials.gov ID
- NCT05297383
- Acronym / sponsor ID
- 2019-07195-P
- Conditions
- Obesity, Inflammation, Insulin Resistance, Dyslipidemias, Gut Microbiome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- University of Houston, Texas Tech University Health Sciences Center
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to understand the combined effects of fish oil and exercise in obesity-associated inflammation acutely. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and reduce inflammation and metabolic risk.
Detailed description
Incidence of obesity continues to increase in the United States and worldwide, making its prevention or reduction a public health priority. Nutrition research that can lead to effective prevention strategies is greatly needed. Inflammation is a major underlying cause for obesity, and it is imperative that we understand how anti-inflammatory food sources, such as fish oil, could aid in reducing obesity. Moreover, exercise is effective at reducing systemic inflammation and improving insulin resistance. Both exercise and diet can influence health through changes in the gut microbiome; however, no studies have investigated how together these affect gut microbiome and overall metabolic health. The goal 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 reduce inflammation and metabolic risk. This study will provide the foundation for development of novel strategies for obesity, inflammation, dyslipidemia and dysglycemia.
Aim 1: Determine combined effects of n-3 PUFA and HIIT on improving metabolic risk:
The investigators will test the hypothesis that n-3 PUFA in addition to HIIT will have beneficial effects on obesity-related markers of inflammation, dyslipidemia and insulin resistance in placebo, n-3 or exercise alone, and combined n-3 and exercise.
Aim 1.1: Investigate the influence of n-3 PUFA and HIIT on body weight and composition:
At baseline (week 0), anthropometric assessments will be performed, including: (1) height (m); (2) weight (kg); (3) waist circumference (cm); (4) hip circumference (cm); and body composition which will be assessed utilizing dual-energy X-ray absorptiometry (DXA) scanning. Anthropometric measures will be repeated at post-intervention (week 6).
Aim 1.2: Investigate the influence of n-3 PUFA and HIIT on serum markers associated with obesity
Fasting blood samples collected at weeks 1 and 6 will be analyzed for (1) markers of inflammation, including high sensitivity C-reactive protein (hs-CRP), IL-6, IL-10, MCP-1, and TNF-α; (2) adipokines, including adiponectin, resistin, and leptin; and (3) indices of systemic insulin resistance, including insulin and fasting blood glucose and (4) indices of dyslipidemia, including total cholesterol, high-density, lipoprotein (HDL), non-HDL, low- and very low-density lipoproteins (LDL and VLDL), total/HDL cholesterol, and triglycerides (TG) utilizing ELISA kits or Luminex analyzer [1] in the Nutrition, Exercise, \& Translational (NExT) Medicine Lab in the Department of Kinesiology \& Sport Management, TTU, Lubbock.
Aim 2: Determine combined effects of n-3 PUFA and HIIT on improving gut dysbiosis:
The investigators will test the hypothesis that n-3 PUFA supplementation will improve gut microbiota composition and related metabolites, which will result in reduced inflammation and ameliorate the metabolic response to a HIIT exercise intervention in an overweight population. This will be accomplished by identifying alterations in gut microbiota profiles following n-3 supplementation, HIIT or the interactive effects of both HIIT and n-3 PUFA.
Aim 2.1: Investigate the influence of n-3 PUFA and exercise on gut microbiota composition
Fecal samples will be collected by participants at their convenience in their homes and less than 24 hours prior to visiting the lab. Samples will be brought to the lab at weeks 1 and 6. Samples will be collected at home with investigator prepared kits and will be stored at -80°C until DNA extraction. Metagenomics analyses will be conducted in consultation with our collaborators at the University of Houston.
Aim 2.2: Investigate the influence of n-3 PUFA and exercise on microbiota produced metabolites
Fecal and serum short-chain fatty acid (SCFA)s, including acetate, propionate and butyrate, will be measured as markers of the above gut bacteria changes and in association with changes in serum markers of inflammation, dyslipidemia and dysglycemia. Fecal and serum SCFAs will be measured utilizing gas chromatography. Analyses will be conducted on fasting blood samples collected at baseline and post-intervention.
Participants will be randomly allocated to 1 of 4 treatment groups (n = 120), each balanced for sex, BMI, lipid profile, and dietary intake.
- placebo (safflower oil, AlaskOmega®) + flexibility (exercise control)
- n-3 PUFA (4 grams, 3000 mg EPA and 1000 mg DHA, AlaskOmega®) + flexibility training (exercise control)
- placebo (safflower oil, AlaskOmega®) + HIIT
- n-3 PUFA + HIIT
The goal is to conduct the study in smaller cohorts, such as 10-15 participants/group (n = 40-60).
4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) will be taken by participants in n-3 PUFA groups for 6 weeks
Placebo (safflower oil, AlaskOmega®, from Organic Technologies Inc.) will be taken by participants in placebo groups for 6 weeks
A 4 x 4 HIIT exercise (4 intervals for 4 min at 85-95% HRmax with 3min active recovery at 50-70% HRmax) program, 3 days/week, conducted under virtual investigator supervision and utilizing cycle ergometers (Keiser M3i Indoor Bike) equipment in collaboration with the TTU Department of Kinesiology \& Sport Management for 6 weeks.
If not asked to exercise, participants will be instructed to maintain their normal level of physical activity but will participate in time-matched control consisting of flexibility training led by investigators for 6 weeks.
All participants will wear a heart rate monitor (Polar H10) provided by TTU throughout the training (HIIT and control) to monitor exertion level.
Capsules will be administered in a double-blind fashion and will be identical in appearance. To ensure compliance, subjects will be reminded via phone (text message or phone call based on participant preference) to take their capsules and counts will be conducted when they come in for study visits.
At the end of the 6-week study, assessments will be repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| n-3 PUFA and flexibility- Control | Active comparator | Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid., Behavioral: Flexibility TrainingParticipants will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) for 6 weeks. Alongside supplementation, participants will be instructed to maintain their normal level of physical activity but will participate in a time-matched control consisting of flexibility training (low-intensity exercise) for 6 weeks. |
| Placebo and flexibility- Control | Placebo comparator | Dietary Supplement: Safflower Oil, Behavioral: Flexibility TrainingParticipants will take Placebo (safflower oil, AlaskOmega®, from Organic Technologies Inc.) will be taken by participants in placebo groups for 6 weeks. Alongside supplementation, participants will be instructed to maintain their normal level of physical activity but will participate in a time-matched control consisting of flexibility training (low-intensity exercise) for 6 weeks. |
| n-3 PUFA and HIIT- Test | Active comparator | Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid., Behavioral: High-Intensity Interval TrainingParticipants will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) for 6 weeks. Alongside supplementation, participants will engage in a 4 x 4 HIIT exercise (4 intervals for 4 min at 85-95% HRmax with 3min active recovery at 50-70% HRmax) program, 3 days/week, for 6 weeks. |
| Placebo and HIIT- Test | Placebo comparator | Dietary Supplement: Safflower Oil, Behavioral: High-Intensity Interval TrainingParticipants will take Placebo (safflower oil, AlaskOmega®, from Organic Technologies Inc.) will be taken by participants in placebo groups for 6 weeks. Alongside supplementation, participants will engage in a 4 x 4 HIIT exercise (4 intervals for 4 min at 85-95% HRmax with 3min active recovery at 50-70% HRmax) program, 3 days/week, for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old.
- Overweight/ Obese.
- Elevated Triglycerides.
- Fasting blood glucose < 126 mg/dL
Key exclusion criteria (9 listed)
- Diagnosed with diabetes, liver disease, or any lower gastrointestinal disease.
- Currently taking blood pressure, diabetes, or lipid lowering medication.
- Received antibiotic treatment within the last 6 months.
- Are pregnant, lactating, have an irregular menstrual cycle, or are menopausal.
- Currently following a structured or formal weight loss program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Polyunsaturated Fatty Acid.Also: AlaskOmega4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA). | Dietary supplement | n-3 PUFA and HIIT- Test, n-3 PUFA and flexibility- Control |
| Safflower OilAlso: Placebo4 grams safflower oil (AlaskOmega®) per day. | Dietary supplement | Placebo and HIIT- Test, Placebo and flexibility- Control |
| High-Intensity Interval TrainingAlso: HIITA 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 6 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. | Behavioural | Placebo and HIIT- Test, n-3 PUFA and HIIT- Test |
| Flexibility TrainingAlso: Flexibility30 min of stretching 3 days/week for 6 weeks | Behavioural | Placebo and flexibility- Control, n-3 PUFA and flexibility- Control |
Primary outcome
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 6 weeks
Time frame: Baseline and 6 weeks
Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)
Mean Change from Baseline in Interleukin (IL)-6 at 6 weeks
Time frame: Baseline and 6 weeks
Interleukin (IL)-6 (pg/mL)
Mean Change from Baseline in Interleukin (IL)-10 at 6 weeks
Time frame: Baseline and 6 weeks
Interleukin (IL)-10 (pg/mL)
Mean Change from Baseline in Monocyte chemoattractant protein-1 at 6 weeks
Time frame: Baseline and 6 weeks
Monocyte chemoattractant protein-1 (MCP-1; pg/mL)
Mean Change from Baseline in Tumor necrosis factor at 6 weeks
Time frame: Baseline and 6 weeks
Tumor necrosis factor (TNF)-alpha (pg/mL)
Mean Change from Baseline in High-density lipoprotein (HDL) at 6 weeks
Time frame: Baseline and 6 weeks
High-density lipoprotein (HDL) (mg/dL)
Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 6 weeks
Time frame: Baseline and 6 weeks
Non-high-density lipoprotein (Non-HDL) (mg/dL)
Mean Change from Baseline in Low-density lipoprotein (LDL) at 6 weeks
Time frame: Baseline and 6 weeks
Low-density lipoprotein (LDL) (mg/dL)
Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 6 weeks
Time frame: Baseline and 6 weeks
Very-low-density lipoprotein (VLDL) (mg/dL)
Mean Change from Baseline in Triglycerides at 6 weeks
Time frame: Baseline and 6 weeks
Triglycerides (mg/dL).
Mean Change from Baseline in Total/HDL cholesterol at 6 weeks
Time frame: Baseline and 6 weeks
Total/HDL cholesterol (mg/dL)
Mean Change from Baseline in Total cholesterol (mg/dL) at 6 weeks
Time frame: Baseline and 6 weeks
Total cholesterol (mg/dL)
Mean Change from Baseline in Insulin at 6 weeks
Time frame: Baseline and 6 weeks
Insulin (μU/mL)
Mean Change from Baseline in Fasting blood glucose at 6 weeks
Time frame: Baseline and 6 weeks
Fasting blood glucose (mg/dL)
Mean Change from Baseline in Skeletal Muscle Mass Percentage at 6 weeks
Time frame: Baseline and 6 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.
Mean Change from Baseline in Total Body Fat Percentage at 6 weeks
Time frame: Baseline and 6 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.
Mean Change from Baseline in Cardio Respiratory Fitness at week 0
Time frame: Baseline and 6 weeks
VO2 Max (mL/kg/min)
4 secondary outcomes
Mean Change from Baseline in Bacterial Profile at 6 weeks
Time frame: Baseline and 6 weeks
Mean Change from Baseline in Serum Acetate Profile at 6 weeks
Time frame: Baseline and 6 weeks
Mean Change from Baseline in Propionate Profile at 6 weeks
Time frame: Baseline and 6 weeks
Mean Change from Baseline in Butyrate Profile at 6 weeks
Time frame: Baseline and 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kembra KA Albracht-Schulte, Ph.D. principal investigator
Texas Tech University
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Polyunsaturated Fatty Acid., Safflower Oil and High-Intensity Interval Training in people with Obesity and Inflammation, run by Texas Tech University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 6 weeks (time frame: Baseline and 6 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.