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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05295719
Other study ID # 2019-07195
Secondary ID GRANT12908084
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date September 1, 2024

Study information

Verified date December 2021
Source Texas Tech University
Contact Kembra D Albracht-Schulte, Ph.D.
Phone +1 (806)-834-5786
Email kembra.albracht@ttu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Dietary Supplement:
Omega-3 polyunsaturated fatty acid
4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA)
Behavioral:
High-Intensity Interval Training
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.
Dietary Supplement:
Safflower oil
4 grams safflower oil (AlaskOmega®) per day
Behavioral:
Flexibility training
30 min of stretching 3 days/week for 6 weeks

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Texas Tech University Texas Tech University Health Sciences Center, University of Houston

Outcome

Type Measure Description Time frame Safety issue
Primary 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-Supplementation at week 8
Primary Mean Change from Baseline in Interleukin (IL)-6 at 8 weeks Interleukin (IL)-6 (pg/mL) Post-Supplementation at week 8
Primary Mean Change from Baseline in Interleukin (IL)-10 at 8 weeks Interleukin (IL)-10 (pg/mL) Post-Supplementation at week 8
Primary Mean Change from Baseline in Monocyte chemoattractant protein-1 at 8 weeks Monocyte chemoattractant protein-1 (MCP-1; pg/mL) Post-Supplementation at week 8
Primary Mean Change from Baseline in Tumor necrosis factor at 8 weeks Tumor necrosis factor (TNF)-alpha (pg/mL) Post-Supplementation at week 8
Primary Mean Change from Baseline in Total Cholesterol at 8 weeks Total cholesterol (mg/dL) Post-Supplementation at week 8
Primary Mean Change from Baseline in High-density lipoprotein (HDL)at 8 weeks High-density lipoprotein (HDL) (mg/dL) Post-Supplementation at week 8
Primary Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 8 weeks Non-high-density lipoprotein (Non-HDL) (mg/dL) Post-Supplementation at week 8
Primary Mean Change from Baseline in Low-density lipoprotein (LDL) at 8 weeks Low-density lipoprotein (LDL) (mg/dL) Post-Supplementation at week 8
Primary Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 8 weeks Very-low-density lipoprotein (VLDL) (mg/dL) Post-Supplementation at week 8
Primary Mean Change from Baseline in Triglycerides at 8 weeks Triglycerides (mg/dL). Post-Supplementation at week 8
Primary Mean Change from Baseline in Total/HDL cholesterol at 8 weeks Total/HDL cholesterol (mg/dL) Post-Supplementation at week 8
Primary Mean Change from Baseline in Fasting blood glucose at 8 weeks Fasting blood glucose (mg/dL) Post-supplementation at week 8
Primary Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 8 weeks Oral glucose tolerance test (OGTT) (mg/dL). 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-supplementation at week 8
Primary Mean Change from Baseline in Insulin at 8 weeks Insulin (µU/mL) Post-supplementation at week 8
Primary 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-Supplementation at week 8
Primary Mean Change from Baseline in Body weigh at 8 weeks Body weight (kilograms) Post-Supplementation at week 8
Primary 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-Supplementation at week 8
Primary Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 14 weeks Serum high-sensitivity C-reactive protein (hs-CRP; mg/L) Post-Intervention at week 14
Primary Mean Change from Baseline in Monocyte chemoattractant protein-1 at 14 weeks Monocyte chemoattractant protein-1 (MCP-1; pg/mL) Post-Intervention at week 14
Primary Mean Change from Baseline in Interleukin (IL)-6 at 14 weeks Interleukin (IL)-6 (pg/mL) Post-Intervention at week 14
Primary Mean Change from Baseline in Interleukin (IL)-10 at 14 weeks Interleukin (IL)-10 (pg/mL) Post-Intervention at week 14
Primary Mean Change from Baseline in Tumor necrosis factor (TNF) at 14 weeks Tumor necrosis factor (TNF)-alpha (pg/mL) Post-Intervention at week 14
Primary Mean Change from Baseline in Total Cholesterol at 14 weeks Total Cholesterol (mg/dL) Post-intervention at week 14
Primary Mean Change from Baseline in High-density lipoprotein (HDL) at 14 weeks High-density lipoprotein (HDL) (mg/dL) Post-intervention at week 14
Primary Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 14 weeks Non-high-density lipoprotein (Non-HDL) (mg/dL) Post-intervention at week 14
Primary Mean Change from Baseline in Low-density lipoprotein (LDL) at 14 weeks Low-density lipoprotein (LDL) (mg/dL) Post-intervention at week 14
Primary Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 14 weeks Very-low-density lipoprotein (VLDL) (mg/dL) Post-intervention at week 14
Primary Mean Change from Baseline in Triglycerides at 14 weeks Triglycerides (mg/dL). Post-intervention at week 14
Primary Mean Change from Baseline in total/HDL cholesterol at 14 weeks Total/HDL cholesterol (mg/dL) Post-intervention at week 14
Primary Mean Change from Baseline in Fasting blood glucose at 14 weeks Fasting blood glucose (mg/dL) Post-Intervention at week 14
Primary Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 14 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 14
Primary Mean Change from Baseline in Insulin at 14 weeks Insulin (µU/mL) Post-Intervention at week 14
Primary Mean Change from Baseline in Body weight at 14 weeks Body weight (kilograms) Post-Intervention at week 14
Primary Mean Change from Baseline in Total Body Fat Percentage at 14 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 14
Primary Mean Change from Baseline in Skeletal Muscle Mass Percentage at 14 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 14
Primary Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 16 weeks Serum high-sensitivity C-reactive protein (hs-CRP; mg/L) Post-Feeding at week 16
Primary Mean Change from Baseline in Interleukin (IL)-6 at 16 weeks Interleukin (IL)-6 (pg/mL) Post-Feeding at week 16
Primary Mean Change from Baseline in Interleukin (IL)-10 at 16 weeks Interleukin (IL)-10 (pg/mL) Post-Feeding at week 16
Primary Mean Change from Baseline in Tumor necrosis factor (TNF) at 16 weeks Tumor necrosis factor (TNF)-alpha (pg/mL) Post-Feeding at week 16
Primary Mean Change from Baseline in Monocyte chemoattractant protein-1 at 16 weeks Monocyte chemoattractant protein-1 (MCP-1; pg/mL) Post-Feeding at week 16
Primary Mean Change from Baseline in Total Cholesterol at 16 weeks Total Cholesterol (mg/dL) Post-Feeding at week 16
Primary Mean Change from Baseline in High-density lipoprotein (HDL) at 16 weeks High-density lipoprotein (HDL) (mg/dL) Post-Feeding at week 16
Primary Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 16 weeks Non-high-density lipoprotein (Non-HDL) (mg/dL) Post-Feeding at week 16
Primary Mean Change from Baseline in Low-density lipoprotein (LDL) at 16 weeks Low-density lipoprotein (LDL)(mg/dL) Post-Feeding at week 16
Primary Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 16 weeks Very-low-density lipoprotein (VLDL) (mg/dL) Post-Feeding at week 16
Primary Mean Change from Baseline in Total/HDL cholesterol at 16 weeks Total/HDL cholesterol (mg/dL) Post-Feeding at week 16
Primary Mean Change from Baseline in Triglycerides at 16 weeks Triglycerides (mg/dL) Post-Feeding at week 16
Primary Mean Change from Baseline in Insulin at 16 weeks Insulin (µU/mL) Post-Feeding at week 16
Primary Mean Change from Baseline in Fasting blood glucose at 16 weeks Fasting blood glucose (mg/dL) Post-Feeding at week 16
Primary Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 16 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-Feeding at week 16
Primary Mean Change from Baseline in Skeletal Muscle Mass Percentage at 16 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-Feeding at week 16
Primary Mean Change from Baseline in Body weight at 16 weeks Body weight (kilograms) Post-Feeding at week 16
Primary Mean Change from Baseline in Total Body Fat Percentage at 16 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-Feeding at week 16
Primary Mean Change from Post-Supplementation in Serum high-sensitivity C-reactive protein at 14 weeks Serum high-sensitivity C-reactive protein (hs-CRP; mg/L) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in Interleukin (IL)-6 at 14 weeks Interleukin (IL)-6 (pg/mL) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in Interleukin (IL)-10 at 14 weeks Interleukin (IL)-10 (pg/mL) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in Monocyte chemoattractant protein-1 at 14 weeks Monocyte chemoattractant protein-1 (MCP-1; pg/mL) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in Tumor necrosis factor (TNF) at 14 weeks Tumor necrosis factor (TNF)-alpha (pg/mL) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in Total Cholesterol at 14 weeks Total Cholesterol (mg/dL) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in Total/HDL cholesterol at 14 weeks Total/HDL cholesterol (mg/dL) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in High-density lipoprotein (HDL) at 14 weeks High-density lipoprotein (HDL) (mg/dL) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in Non-high-density lipoprotein (Non-HDL) at 14 weeks Non-high-density lipoprotein (Non-HDL) (mg/dL) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in Low-density lipoprotein (LDL) at 14 weeks Low-density lipoprotein (LDL) (mg/dL) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in Very-low-density lipoprotein (VLDL) at 14 weeks Very-low-density lipoprotein (VLDL) (mg/dL) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in Triglycerides at 14 weeks Triglycerides (mg/dL) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in Insulin at 14 weeks Insulin (µU/mL) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in Oral glucose tolerance test (OGTT) at 14 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 14
Primary Mean Change from Post-Supplementation in Fasting blood glucose at 14 weeks Fasting blood glucose (mg/dL) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in Body weight at 14 weeks Body weight (kilograms) Post-Intervention at week 14
Primary Mean Change from Post-Supplementation in Total Body Fat Percentage at 14 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 14
Primary Mean Change from Post-Supplementation in Skeletal Muscle Mass Percentage at 14 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 14
Primary Mean Change from Post-Intervention in Serum high-sensitivity C-reactive protein at 16 weeks Serum high-sensitivity C-reactive protein (hs-CRP; mg/L) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in Tumor Necrosis Factor (TNF) at 16 weeks Tumor necrosis factor (TNF)-alpha (pg/mL) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in Interleukin (IL)-6 at 16 weeks Interleukin (IL)-6 (pg/mL) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in Interleukin (IL)-10 at 16 weeks Interleukin (IL)-10 (pg/mL) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in Monocyte Chemoattractant Protein-1 at 16 weeks Monocyte chemoattractant protein-1 (MCP-1; pg/mL) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in Total Cholesterol at 16 weeks Total Cholesterol (mg/dL) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in High-density lipoprotein (HDL) at 16 weeks High-density lipoprotein (HDL) (mg/dL) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in Non-high-density lipoprotein (Non-HDL) at 16 weeks Non-high-density lipoprotein (Non-HDL) (mg/dL) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in Low-density lipoprotein (LDL) at 16 weeks Low-density lipoprotein (LDL) (mg/dL) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in Very-low-density lipoprotein (VLDL) at 16 weeks Very-low-density lipoprotein (VLDL) (mg/dL) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in Total/HDL cholesterol at 16 weeks Total/HDL cholesterol (mg/dL) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in Triglycerides at 16 weeks Triglycerides (mg/dL) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in Insulin at 16 weeks Insulin (µU/mL) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in Fasting blood glucose at 16 weeks Fasting blood glucose (mg/dL) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in Oral glucose tolerance test (OGTT) at 16 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-Feeding at week 16
Primary Mean Change from Post-Intervention in Body weight at 16 weeks Body weight (kilograms) Post-Feeding at week 16
Primary Mean Change from Post-Intervention in Total Body Fat Percentage at 16 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-Feeding at week 16
Primary Mean Change from Post-Intervention in Skeletal Muscle Mass Percentage at 16 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-Feeding at week 16
Secondary Mean Change from Baseline in Bacterial Profile at 8 weeks Fecal Microbial DNA (16s Sequencing) Post-Supplementation at week 8
Secondary Mean Change from Baseline in Serum Acetate Profile at 8 weeks Serum Acetate (SCFA: gas chromatography analysis) Post-Supplementation at week 8
Secondary Mean Change from Baseline in Fecal acetate Profile at 8 weeks Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Supplementation at week 8
Secondary Mean Change from Baseline in Propionate Profile at 8 weeks Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Supplementation at week 8
Secondary Mean Change from Baseline in Butyrate Profile at 8 weeks Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Supplementation at week 8
Secondary Mean Change from Baseline in Markers of Serum lipopolysaccharides at 8 weeks Serum lipopolysaccharides (LPS, ng/ml) Post-Supplementation at week 8
Secondary Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 8 weeks Serum lipopolysaccharides-binding protein (LBP, pg/ml) Post-Supplementation at week 8
Secondary Mean Change from Baseline in Bacterial Profile at 14 weeks Fecal Microbial DNA (16s Sequencing) Post-Intervention at week 14
Secondary Mean Change from Baseline in Serum Acetate Profile at 14 weeks Serum Acetate (SCFA: gas chromatography analysis) Post-Intervention at week 14
Secondary Mean Change from Baseline in Fecal acetate Profile at 14 weeks Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Intervention at week 14
Secondary Mean Change from Baseline in Propionate Profile at 14 weeks Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Intervention at week 14
Secondary Mean Change from Baseline in Butyrate Profile at 14 weeks Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Intervention at week 14
Secondary Mean Change from Baseline in Markers of Serum lipopolysaccharides at 14 weeks Serum lipopolysaccharides (LPS, ng/ml) Post-Intervention at week 14
Secondary Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 14 weeks Serum lipopolysaccharides-binding protein (LBP, pg/ml) Post-Intervention at week 14
Secondary Mean Change from Baseline in Serum Acetate Profile at 16 weeks Serum Acetate (SCFA: gas chromatography analysis) Post-Feeding at week 16
Secondary Mean Change from Baseline in Fecal acetate Profile at 16 weeks Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Feeding at week 16
Secondary Mean Change from Baseline in Bacterial Profile at 16 weeks Fecal Microbial DNA (16s Sequencing) Post-Feeding at week 16
Secondary Mean Change from Baseline in Propionate Profile at 16 weeks Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Feeding at week 16
Secondary Mean Change from Baseline in Butyrate Profile at 16 weeks Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Feeding at week 16
Secondary Mean Change from Baseline in Markers of Serum lipopolysaccharides at 16 weeks Serum lipopolysaccharides (LPS, ng/ml) Post-Feeding at week 16
Secondary Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 16 weeks Serum lipopolysaccharides-binding protein (LBP, pg/ml) Post-Feeding at week 16
Secondary Mean Change from Post-Supplementation in Bacterial Profile at 14 weeks Fecal Microbial DNA (16s Sequencing) Post-Intervention at week 14
Secondary Mean Change from Post-Supplementation in Serum Acetate Profile at 14 weeks Serum Acetate (SCFA: gas chromatography analysis) Post-Intervention at week 14
Secondary Mean Change from Post-Supplementation in Fecal acetate Profile at 14 weeks Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Intervention at week 14
Secondary Mean Change from Post-Supplementation in Propionate Profile at 14 weeks Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Intervention at week 14
Secondary Mean Change from Post-Supplementation in Butyrate Profile at 14 weeks Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Intervention at week 14
Secondary Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides at 14 weeks Serum lipopolysaccharides (LPS, ng/ml) Post-Intervention at week 14
Secondary Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides-binding protein at 14 weeks Serum lipopolysaccharides-binding protein (LBP, pg/ml) Post-Intervention at week 14
Secondary Mean Change from Post-Intervention in Bacterial Profile at 16 weeks Fecal Microbial DNA (16s Sequencing) Post-Feeding at week 16
Secondary Mean Change from Post-Intervention in Serum Acetate Profile at 16 weeks Serum Acetate (SCFA: gas chromatography analysis) Post-Feeding at week 16
Secondary Mean Change from Post-Intervention in Fecal acetate Profile at 16 weeks Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Feeding at week 16
Secondary Mean Change from Post-Intervention in Propionate Profile at 16 weeks Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Feeding at week 16
Secondary Mean Change from Post-Intervention in Butyrate Profile at 16 weeks Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS)) Post-Feeding at week 16
Secondary Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides at 16 weeks Serum lipopolysaccharides (LPS, ng/ml) Post-Feeding at week 16
Secondary Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides-binding protein at 16 weeks Serum lipopolysaccharides-binding protein (LBP, pg/ml) Post-Feeding at week 16
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