Standard Process 21 Day Purification Program Project
SPPP
The Effects of the Standard Process 21 Day Purification Program, on Serum Lipids, C-Reactive Protein, Homocystine, Blood Pressure, and Heart Rate Variability in Normal Weight and Overweight Participants Who Have Total Cholesterol Levels Over 180.
1 other identifier
interventional
40
1 country
1
Brief Summary
To determine the effects of a commercially available dietary modification plus nutritional supplement regimen, the Standard Process 21 day Purification Program (SPPP), on serum lipids, C-reactive protein (CRP), homocysteine, body mass index (BMI), body weight, blood pressure, and heart rate variability (HRV) in normal weight (BMI \< 26) and overweight (BMI 26 or above) participants who have total cholesterol levels over 180.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJuly 29, 2008
July 1, 2008
8 months
July 25, 2008
July 28, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Serum lipids
Before and 3 weeks after starting SPPP (dietary modification + whole food supplements)
Secondary Outcomes (1)
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, homocysteine, C-reactive protein, blood pressure, heart rate variability, body mass index
Before and 3 weeks after starting SPPP (dietary modification + whole food supplements)
Study Arms (2)
Normal weight
EXPERIMENTALBMI \< 26
Overweight
EXPERIMENTALBMI \>= 26
Interventions
The Standard Process 21 Day Purification Program (SPPP) consists of a controlled food intake regimen of mostly fruit and vegetables with restricted calories, protein and fats plus daily use of herbal and whole food based supplements.
Eligibility Criteria
You may qualify if:
- The two experimental groups will be 1. normal weight participants (BMI \< 26) and 2. overweight participants (BMI 26 or above).
- All participants will have total cholesterol levels over 180.
- Both male and female subjects between the ages of 18-65 will be included in the study.
You may not qualify if:
- Individuals with diabetes, heart, kidney, thyroid disorders, neurological diseases, and chronic disease will be excluded from the study.
- Female subjects who are pregnant or breast feeding and those using blood lipid modifying medications and/or supplements drugs and/or hypertension will be excluded from study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Logan College of Chiropractic
Chesterfield, Missouri, 63017, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 29, 2008
Study Start
July 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
July 29, 2008
Record last verified: 2008-07