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Juice Plus+ Study on Pregnancy Outcomes

September 17, 2009
The first Juice Plus+ study on Pregnancy Outcomes was incredible. Now, researchers at the University of Mississippi are doing a prospective, randomized, double-blinded, placebo-controlled study on pregnancy outcomes in both low-risk and high-risk pregnancies. If the results of this study are anything close to the results of Dr. Odom’s retrospective study, Juice Plus+ will be the standard of care in America and likely across the world for reducing pregnancy risks, specifically preeclampsia.
I’ve met Dr. Doug Odom personally at several nutrition conferences and he is the sweetest, kindest, most loving obstetrician I’ve ever met. He is so kind, so brilliant, and down to earth. He said when he first saw the results of the study he was blown away. He couldn’t believe that there was not one single child in the study on Juice Plus+ who had preeclampsia, toxemia, or gestational diabetes.
Here’s just an update on the study’s progress and design:
Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia
This study is currently recruiting participants.
Verified by University of Mississippi Medical Center, July 2009
First Received: December 20, 2007   Last Updated: July 1, 2009   History of Changes
Sponsors and Collaborators: University of Mississippi Medical Center
NSA, LLC
Information provided by: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00583635

Purpose 

Use of Juice Plus+ food supplements, when initiated in the first trimester and used continuously thereafter, will result in a lower incidence of preeclampsia and pregnancy complications. Study sponsored by NSA, LLC.

Condition
Preeclampsia
Pregnancy Loss
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Minimizing Early Pregnancy Oxidative Stress to Maximize Healthy Pregnancy Outcome: Reducing Preeclampsia and Reproductive Loss With Antioxidant-Rich Tablet Supplementation Initiated in the First Trimester

Resource links provided by NLM:

Further study details as provided by University of Mississippi Medical Center:
 

Primary Outcome Measures: 

  • Development of preeclampsia during pregnancy [ Time Frame: Preeclampsia at any time during gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures: 

  • The observed incidence of preterm labor, premature rupture of membranes, perinatal loss [ Time Frame: First, second and third trimester ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description: 

Blood to be analyzed for various markers, then discarded, none to be retained.

Estimated Enrollment: 300
Study Start Date: May 2004
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts

Low Risk Pregnancy, Placebo

Low Risk Pregnancy, Active Food Supplement

High Risk Pregnancy, Placebo

High Risk Pregnancy, Active Food Supplement

Detailed Description:

Not desired

Eligibility 

Ages Eligible for Study: 18 Years to 44 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population

Patients cared for in the University of Mississippi Medical Center

Criteria

Inclusion Criteria:

  • Pregnant Patients seen in first trimester with low or high risk pregnancy

Exclusion Criteria:

  • Pregnant patients first seen after the first trimester
  • Unlikely to continue care in our system
  • Unwilling to comply with rigor of taking food supplements throughout gestation

Contacts and Locations

More Information
No publications provided

Responsible Party: Professor OBGYN, University of Mississippi Medical Center ( James N. Martin, Jr., MD )
Study ID Numbers: IRB File # 2003-0119
Study First Received: December 20, 2007
Last Updated: July 1, 2009
ClinicalTrials.gov Identifier: NCT00583635 History of Changes
Health Authority: United States: Institutional Review Board


Keywords provided by University of Mississippi Medical Center:

Preeclampsia
Prevention
Food Supplement


Study placed in the following topic categories:

Hypertension, Pregnancy-Induced
Antioxidants
Pregnancy Complications
Eclampsia
Stress
Pre-Eclampsia
Healthy
Preeclampsia
Hypertension


Additional relevant MeSH terms:

Hypertension, Pregnancy-Induced
Antioxidants
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Pre-Eclampsia
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2009

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8 Comments leave one →
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    April 3, 2011 6:07 am

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    April 7, 2011 2:20 am

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  3. Anonymous permalink
    April 7, 2011 1:52 pm

    Good Article

  4. Tina Duncan permalink
    May 11, 2011 3:42 am

    Those are some amazing statistics on pregnancy outcomes. Where can we get a copy of the published study?

  5. December 14, 2011 7:40 pm

    Glad to see the research behind my well-made decision to take Juice Plus as my prenatal instead of the yucky things that they want you to take.

  6. McCool11 permalink
    March 27, 2012 2:11 pm

    I suggest doing more research before throwing out those prenatal vitamins. There are a lot of conflicting arguments for and against Juice Plus as a ‘stand-in’ for prenatals. It is lacking in some of the ‘majors’ such as folate and iron and excessive in vitamin A which can be dangerous.

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