Randomized controlled trial of 100 subjects, 71 completed 3 cycles of the ProLon® either in a randomized phase (N=39) or after being crossed over from a control diet group to the FMD group (N=32). Control subjects continued their normal diet. ProLon® participants consumed the fasting mimicking diet (FMD) for 5 consecutive days per month for 3 months. Measurements were performed prior to the diet (Before) and during the recovery period after the 3rd cycle (After).
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Clinical Study Methodology
Clinical Study Results
IGF-1, marker associated with increased mortality and DNA damage in human cells, was reduced by 14%.
C-reactive protein (CRP) levels decreased from 1.5 mg/L to 1.0 mg/L after participants had resumed their normal diet for 5-8 days after cycle 3.
A transient, major, and significant elevation of stem cell/regenerative markers was also observed.
Participants lost an average of 5 lbs.
The weight loss came mostly from abdominal fat shown as reduction in abdominal fat mass.
> 1-inch loss in waist circumference.
Lean body mass was preserved.
Blood pressure (BP) was significantly reduced from 117.4 to 113.6 mm Hg (systolic).
And 75.7 to 72.8 mm Hg (diastolic).
Total cholesterol was reduced nearly 10 mg/dl with significant reductions of LDL from 104.9 to 99.2 mg/dl.
Prolon and Elevated Risk Cohorts
In obese participants (BMl>30), body weight decreased 9 lbs.
Weight remained significantly lower after subjects returned to their normal diet for an average of 3 months. In overweight participants (BMl>25), abdominal fat was reduced by >7%.
With preserved relative lean body mass and decreased waist circumference by approximately >3 cm.
In participants with high cholesterol (>199 mg/dl), total cholesterol was reduced by 20 mg/dl and LD-cholesterol reduced by 15 mg/dl.
In participants with high triglycerides (>100 mg/dl), triglyceride levels were reduced by >25 mg/dl.
For participants with high blood pressure (>120/80) systolic and diastolic BPs were reduced by >6 mmHg.
Blood pressure remained significantly reduced after subjects returned to their normal diet of an average of 3 months. In high fasting glucose participants (>99mg/dl), fasting glucose was reduced by <10mg/dl and remained reduced after subject returned to their normal diet for an average of 3 months. in low glucose participants (<99mg/dl), fasting glucose remained unchanged.
lGF-1, was reduced by 20% in participants with high lGF-1 levels.
In participants at an average risk for developing cardiovascular disease (C-reactive protein between 1-3 mg/L), CRP was lowered >1 mg/L closer to the lowest risk range.