Low dose CSO for Metabolic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nutrition Research Laboratory, Bozeman, MT
Metabolic Syndrome+3 More
High dose CSO - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Metabolic Syndrome
  • Inflammation
  • Healthy Subjects (HS)
  • Stress Oxidative

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

8 Primary · 5 Secondary · Reporting Duration: 1 month

1 day
Acute Diet
Aerobic Fitness
1 month
Habitual Diet
4 weeks
Blood Pressure
Body Mass Index
Body composition
Fasting Eicosanoids
Fasting glucose
Fasting insulin
Fasting serum bile acid concentration
Fasting serum inflammatory cytokines
Fasting serum lipidome and metabolome features (Untargeted)
Fasting serum lipids
Serum oxidative stress biomarkers
Visceral Adipose Tissue
7 days
Physical activity and sedentary behavior

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

High dose OO
1 of 4
Low dose OO
1 of 4
Low dose CSO
1 of 4
High dose CSO
1 of 4
Active Control
Experimental Treatment

32 Total Participants · 4 Treatment Groups

Primary Treatment: Low dose CSO · No Placebo Group · N/A

Low dose CSO
Behavioral
Experimental Group · 1 Intervention: Low dose CSO · Intervention Types: Behavioral
High dose CSO
Behavioral
Experimental Group · 1 Intervention: High dose CSO · Intervention Types: Behavioral
High dose OO
Behavioral
ActiveComparator Group · 1 Intervention: High dose OO · Intervention Types: Behavioral
Low dose OO
Behavioral
ActiveComparator Group · 1 Intervention: Low dose OO · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month
Closest Location: Nutrition Research Laboratory · Bozeman, MT
2019First Recorded Clinical Trial
1 TrialsResearching Metabolic Syndrome
1 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between the ages of 18-55 years.
You have a body mass index between 18-27 kg/m2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.