NCT03084913

Brief Summary

This study compared a plant-based, olive oil diet to the diet recommended by the Prostate Cancer Foundation for weight loss and improvement in some laboratory biomarkers.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

March 9, 2017

Last Update Submit

March 20, 2017

Conditions

Prostate Cancer

Keywords

dietary treatment

Outcome Measures

Primary Outcomes (1)

  • weight loss

    8 weeks

Secondary Outcomes (1)

  • improvement in in fasting blood glucose and insulin

    8 weeks

Study Arms (2)

Prostate Cancer Foundation diet

ACTIVE COMPARATOR

Intervention: 8-weeks of a Prostate Cancer Foundation diet

Other: Plant- based, olive oil dietOther: Prostate Cancer Foundation diet

plant- based, olive oil diet

EXPERIMENTAL

Intervention: 8 weeks of a plant-based, olive oil diet

Other: Plant- based, olive oil dietOther: Prostate Cancer Foundation diet

Interventions

Plant- based, olive oil dietOTHER

used as part of daily diet, followed for 8 weeks

Also known as: plant-based, olive oil diet
Prostate Cancer Foundation dietplant- based, olive oil diet
Prostate Cancer Foundation dietOTHER

followed for 8 weeks

Prostate Cancer Foundation dietplant- based, olive oil diet

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate cancer
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • prostate cancer, BMI 25.0 to 40.0 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Mary M Flynn, PhD, RD

    Research Dietitian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research dietitian, Associate professor of Medicine

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 21, 2017

Study Start

January 1, 2015

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

March 21, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share