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

NCT05439590 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2023-11-18

No results posted yet for this study

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

Interventions

BEHAVIORAL

High dose CSO

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.

BEHAVIORAL

Low dose CSO

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.

BEHAVIORAL

Low dose OO

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.

BEHAVIORAL

High dose OO

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.

Sponsors & Collaborators

  • Montana State University

    lead OTHER

Principal Investigators

  • Mary P. Miles, PhD · Montana State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-08
Primary Completion
2023-11-03
Completion
2023-11-03

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05439590 on ClinicalTrials.gov