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.
Elevated low-density lipoprotein (LDL) cholesterol concentrations are a risk factor for
cardiovascular diseases. (1) Cholesterol lowering drugs are the most frequently prescribed
medications in the U.S. and are known to have muscle, kidney and liver side effects for some
users. Recent reviews conclude that benefits outweigh risks reporting statin and other
cholesterol-lowering drugs to be safe and effective for most users. (2, 3, 4, 5) The new
blood cholesterol level guidelines may recommend that more people take cholesterol lowering
medications. According to the American Heart Association (AHA), total cholesterol levels
should be below 180 mg/dL, with levels from 200 mg/dL to 239 mg/dL considered borderline
high. Total cholesterol of 240 mg/dL and above is considered high. (6) However, published
studies on the effect of blood lipids suggested that the actual cholesterol level itself is
not the most important risk factor. It is the ratio between the level of total cholesterol
and HDL that played a major role in the cardiovascular risk. The ideal HDL/cholesterol ratio
should be higher than 25%. The ideal triglyceride/cholesterol ratio should be below 2.0. It
is estimated that over 50 million adults in the U.S. have lipid levels higher than the above
recommendations. (6) For persons who prefer conservative care, dietary modification is
considered a first approach to the treatment and control of high cholesterol. (1, 7, 8)
Hypertension is another risk factor for cardiovascular diseases and has close links to high
blood cholesterol. (8) Between 40 and 50 million Americans have hypertension, which is
defined as systolic blood pressure of at least 140 mm Hg or diastolic blood pressure of at
least 90 mm Hg. (8) Hypertension is strongly, continuously, and independently related to
coronary artery disease (CAD), stroke, renal disease, and all-cause mortality. For every
7.5-mm Hg increase in diastolic blood pressure, CAD risk increases 29% and stroke risk
increases 46%. These risks have been shown for women as well as for men. Even within the
high-normal blood pressure range, higher measurements result in greater risk of
cardiovascular diseases. (9-10) It has been reported that diet and nutritional supplements
are effective in reducing elevated blood pressure and reducing the risk of heart attack and
stroke. (11-15) Diet and supplements have also been shown to have effects in reducing blood
cholesterol. (16, 17)
Traditional dietary control has focused on reducing intake of saturated fat and cholesterol.
Recent studies have suggested that the traditional focus of lipid management may have been
overly simplistic and that diets might be more effective if more attention was given on
including certain foods or factors rather than just avoiding saturated fat and cholesterol.
Gardner et al 2005 reported improved results with more plant-based foods, such as whole
grains, vegetables, legumes, and fruits while simultaneously limiting saturated fat and
cholesterol. (17) It has been reported that nutritional supplements and diet can reduce
serum lipids and blood pressure. There are no reports on the effects of nutritional
supplement on HRV despite the close link of the autonomic nervous system activity on
regulation of blood pressure.
The Standard Process 21 day Purification Program 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. A recent case series of 28 chiropractic
patients showed that the use of the SPPP resulted in significantly lowered total
This study will investigate the effects of the SPPP in participants with elevated total
cholesterol. The program requires the subjects to eat a modified; mostly fruits and
vegetables diet and take the SPPP nutritional supplements for three weeks
The outcome measures of this study are supported in the literature as risk factors for
cardiovascular and other conditions, e.g., serum lipids, C - reactive protein, homocystine,
blood pressure, high BMI and heart rate variability (HRV).
- 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
- Exclusion criteria are based on factors that could interfere with the effects of the
SPPP on the outcome measures and/or the safety of the participants as follows:
- 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