Juice Plus+ and Juice Plus+ Complete in Ovarian Cancer

July 31, 2026 updated by: M.D. Anderson Cancer Center

A Randomized Phase II Study of the Nutritional Supplements Juice Plus + and Juice Plus + Complete in Ovarian Cancer Patients

The goal of this clinical research study is to see if ovarian cancer patients who add Juice PLus+ and Juice Plus+ Complete to their diets have better outcomes when compared to ovarian cancer patients who receive only dietary counseling alone.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Before starting the study, patients will have a dietary pattern evaluation, physical exam, blood test, height, weight, hip, wrist, mid-arm and waist circumference measurements.

Researchers will compare changes in weight, waist, hip, mid-arm and wrist size, and changes in the amount of vitamins, iron, and nutrients in the blood. Researchers will also measure the levels of some proteins that can be linked to ovarian tumors.

Patients will be randomly picked (as in the toss of a coin) to be in one of two groups. One group will receive free of charge nutritional counseling for 6 months, while the second group will receive free of charge daily supplements . These supplements will be made up of a combination from fruits and vegetables (Juice Plus+). Patients will be asked to take two capsules (Juice Plus+) in the morning, and two capsules (Juice Plus+) along with a drink containing vitamins and minerals (Juice Plus+ Complete) in the evening for 6 months.

All patients will have their eating patterns monitored for six months. Patients will come to the clinic at least every three months as part of their normal treatment schedule. Each visit will take 3 hours and will include a physical exam, blood tests, and anthropometric measurements (height, weight, waist, hip, mid-arm, and wrist circumferences). At some visits, dietary and quality of life assessments will also be done.

With the exception of the first interview, nutritional counseling will be mostly done by a 30 to 60 minute telephone call once a week for two months. Counseling will also be done once every other week for two months and then once a month for two months.

Participation in this study will be stopped if patients have to start being fed by vein, patients get pregnant or begin breast feeding, patients have bowel obstruction, patients are diagnosed with a condition requiring a restricted diet, patients begin medication that is incompatible with a high fiber diet, or patients have severe side effects.

This is an investigational study. A total of 50 patients will take part in this study.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Body Mass Index (BMI) > 19.5
  2. Epithelial ovarian cancer of (any tumor type). Stages 2 and up.
  3. In first clinical remission. (CA125 < 35)
  4. > 21 years of age.
  5. CT scan of abdomen/pelvis without evidence of ovarian cancer.
  6. Ambulatory/mobile and able to eat/not on parenteral nutrition.
  7. Life expectancy of at least 6 months.
  8. Informed consent signed indicating patient's knowledge of the investigational nature of the study.

Exclusion Criteria:

  1. Evidence of bowel obstruction.
  2. Pregnant or lactating.
  3. Diagnosed with a co-morbidity requiring a restricted diet or medication for which a high fiber diet may be contraindicated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Nutritional Counseling
For 6 months control group receives dietary counseling.
Behavioral: Nutritional Counseling
Initial interview and subsequent telephone contact once per week for two months, once every other week for the following two months, and once per month for the remaining two months.
Experimental: Daily Supplements
2 capsules (Juice Plus+) twice a day (morning and evening) plus Juice Plus+ Complete drink each evening for 6 months.
Dietary supplement: Daily Supplements
Two capsules daily in the morning and two capsules daily in the evening of Juice Plus+ in addition to regular meal. Also a beverage, Juice Plus+ Complete (a powder mixture to be added to one cup of fluid) daily in the evening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum lipid peroxide levels resulting from nutritional supplements or dietary counseling
Time Frame: Baseline to 6 months
Measurements of serum lipid peroxide and serum carotenoid levels obtained at baseline and at least every 3 months for total of 6 months; 3 measurements per participant used to assess changes in the lipid peroxide and serum carotenoid levels - baseline measurement during and after treatment. Outcome evaluated using repeated measures ANOVA design with 2 groups and 3 time points.
Baseline to 6 months
Change in levels of serum carotenoid resulting from nutritional supplements or dietary counseling
Time Frame: Baseline to 6 months
Measurements of serum lipid peroxide and serum carotenoid levels obtained at baseline and at least every 3 months for total of 6 months; 3 measurements per participant used to assess changes in the lipid peroxide and serum carotenoid levels - baseline measurement during and after treatment. Outcome evaluated using repeated measures ANOVA design with 2 groups and 3 time points.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Natural Alternatives International

Investigators

  • Principal Investigator: Beverly C. Handy, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2003

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

September 21, 2011

First Submitted That Met QC Criteria

September 21, 2011

First Posted (Estimated)

September 23, 2011

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID00-420
  • NCI-2011-03303 (Registry Identifier: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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