Ovarian CancerPhase 2NCT01439659
Juice Plus+ and Juice Plus+ Complete in Ovarian Cancer
A Phase 2 study testing Nutritional Counseling and Daily Supplements in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Nutritional Counseling and Daily Supplements
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2003to 1 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) > 19.5
- Epithelial ovarian cancer of (any tumor type). Stages 2 and up.
- In first clinical remission. (CA125 < 35)
- > 21 years of age.
- CT scan of abdomen/pelvis without evidence of ovarian cancer.
- Ambulatory/mobile and able to eat/not on parenteral nutrition.
- Life expectancy of at least 6 months.
- Informed consent signed indicating patient's knowledge of the investigational nature of the study.
Who cannot join
- Evidence of bowel obstruction.
- Pregnant or lactating.
- Diagnosed with a co-morbidity requiring a restricted diet or medication for which a high fiber diet may be contraindicated.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- Nutritional Counseling, Daily Supplements
- Keywords
- Ovarian Cancer, Epithelial ovarian cancer, First clinical remission, Nutritional Supplements, Juice Plus +, Juice Plus + Complete, Dietary counseling
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional CounselingBehavioural
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.
Daily SupplementsDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Counseling | Other | For 6 months control group receives dietary counseling. Receives: Behavioral: Nutritional Counseling |
| Daily Supplements | Experimental | 2 capsules (Juice Plus+) twice a day (morning and evening) plus Juice Plus+ Complete drink each evening for 6 months. Receives: Dietary Supplement: Daily Supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum lipid peroxide levels resulting from nutritional supplements or dietary counseling
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.
Measured: Baseline to 6 months
Change in levels of serum carotenoid resulting from nutritional supplements or dietary counseling
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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study start18 Feb 2003
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Alternatives International
- Responsible party
- Sponsor
- Investigators
- Beverly C. Handy, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439659
- Sponsor's protocol ID
- ID00-420
- Other IDs
- NCI-2011-03303
- Status last verified
- Jul 2026
- First submitted
- 21 Sep 2011
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of the Nutritional Supplements Juice Plus + and Juice Plus + Complete in Ovarian Cancer Patients
- ClinicalTrials.gov ID
- NCT01439659
- Acronym / sponsor ID
- ID00-420
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Epithelial ovarian cancer, First clinical remission, Nutritional Supplements, Juice Plus +, Juice Plus + Complete, Dietary counseling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Natural Alternatives International
- Study start
- 18 Feb 2003 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional Counseling | Other | Behavioral: Nutritional CounselingFor 6 months control group receives dietary counseling. |
| Daily Supplements | Experimental | Dietary Supplement: Daily Supplements2 capsules (Juice Plus+) twice a day (morning and evening) plus Juice Plus+ Complete drink each evening for 6 months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Body Mass Index (BMI) > 19.5
- Epithelial ovarian cancer of (any tumor type). Stages 2 and up.
- In first clinical remission. (CA125 < 35)
- > 21 years of age.
- CT scan of abdomen/pelvis without evidence of ovarian cancer.
Key exclusion criteria (3 listed)
- Evidence of bowel obstruction.
- Pregnant or lactating.
- Diagnosed with a co-morbidity requiring a restricted diet or medication for which a high fiber diet may be contraindicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional CounselingInitial 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. | Behavioural | Nutritional Counseling |
| Daily SupplementsTwo 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. | Dietary supplement | Daily Supplements |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverly C. Handy, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nutritional Counseling and Daily Supplements in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum lipid peroxide levels resulting from nutritional supplements or dietary counseling (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.