Combining HIIT and n-3 PUFA Supplementation to Reduce Inflammation and Improve Metabolic Health (HIIT&PUFA)

NCT05297383 | Withdrawn

• 1 other identifier: 2019-07195-P
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 risk.

Conditions

Obesity; Inflammation; Insulin Resistance; Dyslipidemias; Gut Microbiome

Outcome Measures

Primary Outcomes (17)

• Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 6 weeks

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

  Baseline and 6 weeks

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

  Interleukin (IL)-6 (pg/mL)

  Baseline and 6 weeks

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

  Interleukin (IL)-10 (pg/mL)

  Baseline and 6 weeks

• Mean Change from Baseline in Monocyte chemoattractant protein-1 at 6 weeks

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

  Baseline and 6 weeks

• Mean Change from Baseline in Tumor necrosis factor at 6 weeks

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

  Baseline and 6 weeks

• Mean Change from Baseline in High-density lipoprotein (HDL) at 6 weeks

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

  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)

  Baseline and 6 weeks

• Mean Change from Baseline in Low-density lipoprotein (LDL) at 6 weeks

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

  Baseline and 6 weeks

• Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 6 weeks

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

  Baseline and 6 weeks

• Mean Change from Baseline in Triglycerides at 6 weeks

  Triglycerides (mg/dL).

  Baseline and 6 weeks

• Mean Change from Baseline in Total/HDL cholesterol at 6 weeks

  Total/HDL cholesterol (mg/dL)

  Baseline and 6 weeks

• Mean Change from Baseline in Total cholesterol (mg/dL) at 6 weeks

  Total cholesterol (mg/dL)

  Baseline and 6 weeks

• Mean Change from Baseline in Insulin at 6 weeks

  Insulin (μU/mL)

  Baseline and 6 weeks

• Mean Change from Baseline in Fasting blood glucose at 6 weeks

  Fasting blood glucose (mg/dL)

  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.

  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.

  Baseline and 6 weeks

• Mean Change from Baseline in Cardio Respiratory Fitness at week 0

  VO2 Max (mL/kg/min)

  Baseline and 6 weeks

Secondary Outcomes (4)

• Mean Change from Baseline in Bacterial Profile at 6 weeks

  Baseline and 6 weeks

• Mean Change from Baseline in Serum Acetate Profile at 6 weeks

  Baseline and 6 weeks

• Mean Change from Baseline in Propionate Profile at 6 weeks

  Baseline and 6 weeks

• Mean Change from Baseline in Butyrate Profile at 6 weeks

  Baseline and 6 weeks

Study Arms (4)

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.

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.

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.

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.

Dietary Supplement: Safflower Oil; Behavioral: High-Intensity Interval Training

Interventions

Omega-3 Polyunsaturated Fatty Acid. DIETARY_SUPPLEMENT

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

Also known as: AlaskOmega

n-3 PUFA and HIIT- Test; n-3 PUFA and flexibility- Control

Safflower Oil DIETARY_SUPPLEMENT

4 grams safflower oil (AlaskOmega®) per day.

Also known as: Placebo

Placebo and HIIT- Test; Placebo and flexibility- Control

High-Intensity Interval Training BEHAVIORAL

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.

Also known as: HIIT

Placebo and HIIT- Test; n-3 PUFA and HIIT- Test

Flexibility Training BEHAVIORAL

30 min of stretching 3 days/week for 6 weeks

Also known as: Flexibility

Placebo and flexibility- Control; n-3 PUFA and flexibility- Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old.
• Overweight/ Obese.
• Elevated Triglycerides.
• Fasting blood glucose \< 126 mg/dL

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Texas Tech University: lead
• University of Houston: collaborator
• Texas Tech University Health Sciences Center: collaborator

MeSH Terms

Conditions

Obesity; Inflammation; Insulin Resistance; Dyslipidemias

Interventions

Docosahexaenoic Acids; Safflower Oil; High-Intensity Interval Training; Pliability

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mechanical Phenomena; Physical Phenomena

Study Officials

• Kembra KA 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: March 15, 2022
• First Posted: March 28, 2022
• Study Start: April 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: December 31, 2022
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share