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NCT01043939 · ClinicalTrials.gov registry record · Phase 1

Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors

A Phase 1 study, sponsored by University of Minnesota.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT01043939: Completed Phase 1 study, sponsored by University of Minnesota.

NCT01043939 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01043939, a Phase 1 study, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

Rationale: Survivors of childhood cancer are at an increased risk of developing cardiovascular risk factors as well as early cardiovascular disease, likely due to the intensive therapeutic regimen used to treat their cancer. Purple grape juice (PGJ) is a rich source of flavonoids and a powerful antioxidant. Clinical studies in both diseased and healthy adults suggest that daily consumption of PGJ contributes to increased antioxidant capacity, reduced low-density lipoprotein (LDL) oxidation, and improved vasodilation. Purpose: This randomized clinical trial is evaluating whether purple grape juice can reduce oxidative stress and improve the vascular health of survivors of childhood cancer in the early stages of cardiovascular disease.

Primary Outcome

Difference of least square means (95% Confidence Interval) in RH-PAT Index Scores between juice groups. Higher RH-PAT scores indicate better endothelial function; a positive difference of least square means is suggestive of an improvement in endothelial function. Probes were placed on the index fingers of both hands and a blood pressure cuff was placed on one arm. The cuff was inflated to suprasystolic pressure and the digital pulse volume was recorded before, during \& after a 5 minute occlusi

Interventions

  • OTHER Apple Juice
  • OTHER Purple Grape Juice

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2009-11
Est. Completion 2010-12
Phase Phase 1
University of Minnesota

966 total trials

What the finished NCT01043939 record still lists

NCT01043939 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 2 interventions - of which Apple Juice is the first listed.

NCT01043939 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01043939 about?

NCT01043939 is a clinical study titled "Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors". Rationale: Survivors of childhood cancer are at an increased risk of developing cardiovascular risk factors as well as early cardiovascular disease, likely due to the intensive therapeutic regimen used to treat their cancer. Purple grape juice (PGJ) is a rich source of flavonoids and a powerful anti...

What is the current status of trial NCT01043939?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-11. Estimated completion is 2010-12.

What interventions are being tested in trial NCT01043939?

The interventions under investigation include: Apple Juice (OTHER), Purple Grape Juice (OTHER).

Who is sponsoring clinical trial NCT01043939?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01043939's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01043939, the US trial registry maintained by the National Library of Medicine. NCT01043939 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.