Impact of Cottonseed Oil on Oxidative Stress, Inflammation, and Metabolism

NCT05439590 | Completed

• 1 other identifier: Cotton Incorporated 22-070
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Recent research evidence suggests that cottonseed oil (CSO) may have both direct and indirect anti-inflammatory and anti-oxidative impacts linked to bioactive components of CSO and favorable alterations in lipid metabolism. These impacts are directly related to non-communicable diseases such as diabetes, cardiovascular diseases, and cancer. Our overarching hypothesis is that the effect of CSO consumption on oxidative stress markers (isoprostanes), inflammatory cytokines, metabolic biomarkers, and bile acid metabolism will be beneficial for reversing disease pathophysiology linked to oxidative stress, inflammation, and bile acids. Our long-term goal is to establish effective and practical therapeutic strategies utilizing dietary incorporation of CSO to prevent or reverse these diseases. The following hypotheses will be tested in the proposed investigation: H1: CSO consumption will lower exercise-induced oxidative stress, and the effect of CSO will be greater than that of OO for lowering of exercise-induced oxidative stress. H2: CSO consumption will lower inflammatory cytokines and metabolic markers linked to the inflammation process in human participants, and the effect of CSO will be greater than that of OO for lowering inflammation. H3: Features of serum bile acids, serum metabolomes, and lipidomes distinguishing CSO and OO treatment correspond to metabolic pathways illuminating the health benefits of CSO treatment. H4: Metabolic and inflammatory impacts of dietary oils will be greater for 60 g/d of CSO compared to 30 g/d.

Conditions

Inflammation; Healthy; Oxidative Stress; Metabolic Syndrome

Outcome Measures

Primary Outcomes (8)

• Serum oxidative stress biomarkers

  Concentration of exercise-induced serum isoprostanes (nM/L)

  4 weeks

• Fasting serum bile acid concentration

  Concentration of fasting serum bile acids (nM/L)

  4 weeks

• Fasting serum lipids

  Concentration of fasting serum triglycerides, high density lipoproteins, cholesterol, very low density cholesterol (mM)

  4 weeks

• Fasting serum inflammatory cytokines

  Concentration of fasting serum inflammatory cytokine responses (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor; all in pg/ml)

  4 weeks

• Fasting serum lipidome and metabolome features (Untargeted)

  Serum lipidomes and metabolomes features (Untargeted measured using LC-MS)

  4 weeks

• Fasting glucose

  Serum glucose concentration (mM)

  4 weeks

• Fasting insulin

  Serum insulin concentration (microIU/mL)

  4 weeks

• Fasting Eicosanoids

  Several serum prostaglandins, leukotrienes, and thromboxanes (nM)

  4 weeks

Secondary Outcomes (5)

• Body composition

  4 weeks

• Visceral Adipose Tissue

  4 weeks

• Body Mass Index

  4 weeks

• Blood Pressure

  4 weeks

• Aerobic Fitness

  1 day

Other Outcomes (3)

• Habitual Diet

  1 month

• Acute Diet

  1 day

• Physical activity and sedentary behavior

  7 days

Study Arms (4)

High dose CSO

EXPERIMENTAL

Participants will be randomly assigned to a smoothie containing 60 g of CSO per day for four weeks.They will be asked to consume smoothies any time of the day.

Behavioral: High dose CSO

Low dose CSO

EXPERIMENTAL

Participants will be randomly assigned to a smoothie containing 30 g of CSO per day for four weeks.They will be asked to consume smoothies any time of the day.

Behavioral: Low dose CSO

High dose OO

ACTIVE COMPARATOR

Participants will be randomly assigned to a smoothie containing 60 g of OO per day for four weeks.They will be asked to consume smoothies any time of the day.

Behavioral: High dose OO

Low dose OO

ACTIVE COMPARATOR

Participants will be randomly assigned to a smoothie containing 30 g of OO per day for four weeks.They will be asked to consume smoothies any time of the day.

Behavioral: Low dose OO

Interventions

High dose CSO BEHAVIORAL

Participants in the high-dose CSO arm of the study will consume two smoothies containing a total of 60 g of CSO per day for 4 weeks.

Also known as: HD CSO

High dose CSO

Low dose CSO BEHAVIORAL

Participants in the low-dose CSO arm of the study will consume two smoothies containing a total of 30 g of CSO per day for 4 weeks.

Also known as: LD CSO

Low dose CSO

Low dose OO BEHAVIORAL

Participants in the low-dose OO arm of the study will consume two smoothies containing a total of 30 g of OO per day for 4 weeks.

Also known as: LD OO

Low dose OO

High dose OO BEHAVIORAL

Participants in the high-dose OO arm of the study will consume two smoothies containing a total of 60 g of OO per day for 4 weeks.

Also known as: HD OO

High dose OO

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• are between the ages of 18-55 years
• have body mass index between 18-27 kg/m2

You may not qualify if:

• take medications to lower cholesterol, lipids, and/or inflammation,
• take blood pressure medications,
• take antioxidant supplements (Vitamin E or C or iron) at levels greater than 800 IU/day,
• have diabetes, a gallbladder condition, or have had gallbladder removed,
• take oral contraceptives regularly,
• have smoked in the past 30 days,
• consume alcohol more than 14 drinks/week,
• have an allergy to dairy, egg, tree nuts, peanuts, shellfish, soy, fish, wheat, legumes, extra virgin olive oil, and cottonseed oil, or have been on a ketogenic or paleo diet in the past six weeks,
• pregnant or lactating,
• on weight loss diet or planning to change exercise regimen,
• have physical mobility issues or are not able to walk on a treadmill,
• or have other health concerns or conditions that may interfere with your participation in the study

Sponsors & Collaborators

• Montana State University: lead

Study Sites (1)

Nutrition Research Laboratory

Bozeman, Montana, 59717, United States

Location

MeSH Terms

Conditions

Inflammation; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mary P. Miles, PhD

  Montana State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Smoothies containing 30 g CSO, 30 g OO, 60 g CSO, and 60 g OO were designed to be comparable in taste and appearance. The smoothies will be prepared and coded prior to receipt by the research team. Randomization is for order of coded meals.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The design is randomized parallel design, where the healthy adults will be randomized into 30 g CSO, 30 g OO, 60 g CSO, and 60 g OO.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: August 8, 2022
• Primary Completion: November 3, 2023
• Study Completion: November 3, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)