Recruiting

Lipid Metabolism

Sponsor:

University of Tennessee Graduate School of Medicine

Code:

NCT06800105

Conditions

Ovary Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High fat smoothie

Study Details

Brief summary:

Minimal information is available regarding changes in whole-body metabolism in ovarian cancer patients, and no study has assessed whole-body lipid metabolism in this patient population. In this pilot study we will assess fasting and postprandial lipid metabolism of ovarian cancer patients before, during, and after treatment via indirect calorimetry.

Conditions

Ovary Cancer

Study ID

NCT06800105

Start date

Mar 22, 2023

Status verified date

Jan, 2025

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women
  • Age >18
  • Presumed ovarian cancer diagnosis (i.e. those being clinically evaluated for suspicion of ovary cancer)
  • Planned treatment course for ovarian cancer involving cytoreductive surgery followed by chemotherapy
  • Availability to commit to attending all study visits
  • Internet access and consistent access to phone/email/text communication

Exclusion Criteria:

  • Pregnancy
  • Inability to provide voluntary informed consent
  • Inability to consume the pre-study visit meal/snack and/or the study visit meal due to strict dietary restrictions
  • Illicit substance use (e.g. cocaine, methamphetamines, heroin, street drugs) - marijuana and CBD oil and related supplements will be considered on a case-by-case basis by the principal investigators
  • Circumstances and/or medical condition that would limit compliance with study requirements and protocol, as determined by the principal investigators

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with presumed ovarian cancer

Patients with presumed ovarian cancer will complete three, 4-hour study visits at the following time points:

  • The 1st visit will occur before treatment.
  • The 2nd visit will occur after about half of the planned treatment as been completed.
  • The 3rd visit will occur 4-8 weeks after the completion of treatment.

Interventions

High fat smoothie

Participants will consume a standardized 490 kcal high-fat smoothie, consisting of 57% fat, 23% carbohydrate, and 20% protein.

Primary outcome measure

  • Feasibility assessed by attrition [ Time Frame: 60 months ]
  • Feasibility and acceptability assessed by protocol adherence [ Time Frame: 60 months ]

Central Contacts and Locations

Central contacts

Jill M Maples, PhD

8653059367jmaples1@utmck.edu

Locations

University of Tennessee Graduate School of Medicine

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Jill M Maples, PhD

jmaples1@utmck.edu

More Information

Sponsor

University of Tennessee Graduate School of Medicine

Last update posted

Jan 29, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Tennessee Graduate School of Medicine on 2025-01-29.