The Science Behind The Colon Vitamin

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The Colon Vitamin containsnatural micronutrients and antioxidants

that have been shown in scientific studies to promote colon health.*

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* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Natural Micronutrients & Antioxidants

Ingredients Role Impact shown in studies

Micronutrients

Vitamin B2 An important factor in folate metabolism Protects against polyp formation

Vitamin B6 Prevents abnormalities in DNA synthesis, repair, and methylation

Reduced colorectal cancer risk

Folate Increases DNA methylation in colon cells which is important in DNA synthesis & gene stability

Reduced risk of recurrent polyps

Calcium Appears to reduce the risk of colorectal cancer by binding bile & fatty acids and by inhibiting pathological crypt activity

Reduced risk of polyp formation

Antioxidants

Beta Carotene An antioxidant with antineoplastic activity Reduced risk of recurrent polyps

Vitamin D Normal & cancerous cells express Vitamin D receptors which induce anti-cancer reactions

Reduced colorectal cancer risk

Selenium Protects colon cells against a wide range of external and internal stressors, including inhibiting malignant colon cell proliferation

Reduced risk of polyp formation and colorectal cancer risk

Curcumin An antioxidant with antineoplastic activity that potentiates the effect of chemotherapy in colon and other cancers

Phase 3 studies underway in patients with colon cancer

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Beta Carotene: non-smokers & non-alcohol drinkers saw a decrease in the risk of one or more recurrent adenomatous polyps.

Methods: We studied the effect of β-carotene supplementation on colorectal adenoma recurrence among subjects in a multicenter double-blind, placebo-controlled clinical trial of antioxidants for the prevention of colorectal adenomas. A total of 864 subjects who had had an adenoma removed and were polyp-free were randomly assigned (in a factorial design) to receive β-carotene (25 mg or placebo) and/or vitamins C and E in combination (1000 mg and 400 mg, respectively, or placebo), and were followed with colonoscopy for adenoma recurrence 1 year and 4 years after the qualifying endoscopy. A total of 707 subjects had two follow-up examinations and provided smoking and alcohol use data. Adjusted multivariate risk ratios (RRs) and 95% confidence intervals (CIs) were used to assess the effects of β-carotene on adenoma recurrence.

Results: Among subjects who neither smoked cigarettes nor drank alcohol, β-carotene was associated with a marked decrease in the risk of one or more recurrent adenomas (RR = 0.56, 95% CI = 0.35 to 0.89), but β-carotene supplementation conferred a modest increase in the risk of recurrence among those who smoked (RR = 1.36, 95% CI = 0.70 to 2.62) or drank (RR = 1.13, 95% CI = 0.89 to 1.43). For participants who smoked cigarettes and also drank more than one alcoholic drink per day, β-carotene doubled the risk of adenoma recurrence (RR = 2.07, 95% CI = 1.39 to 3.08; P for difference from nonsmoker/nondrinker RR < .001).

Conclusion: Alcohol intake and cigarette smoking appear to modify the effect of β-carotene supplementation on the risk of colorectal adenoma recurrence.

Journal of the National Cancer Institute 2003; 95: 717-722

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Calcium: dietary calcium is associated with decreased incidence of colon polyps.

Epidemiology. 7(3):264-268), May 1996

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Folic Acid (Folate): supplementation is associated with reduced rate of recurrentadenomatous polyps.

World Journal of Gastroenterology 2008; 14: 4492-4498

AIM: To determine whether folic acid supplementation will reduce the recurrence of colorectal adenomas, the precursors of colorectal cancer, we performed a double-blind placebo-controlled trial in patients with adenomatous polyps.

METHODS: In the current double-blind, placebo-controlled trial at this VA Medical Center, patients with colorectal adenomas were randomly assigned to receive either a daily 5 mg dose of folic acid or a matched identical placebo for 3 years. All polyps were removed at baseline colonoscopy and each patient had a follow up colonoscopy at 3 years. The primary endpoint was a reduction in the number of recurrent adenomas at 3 years.

RESULTS: Of 137 subjects, who were eligible after confirmation of polyp histology and run-in period to conform compliance, 94 completed the study; 49 in folic acid group and 45 in placebo group. Recurrence of adenomas at 3-year was compared between the two groups. The mean number of recurrent polyps at 3-year was 0.36 (SD, 0.69) for folic acid treated patients compared to 0.82 (SD, 1.17) for placebo treated subjects, resulting in a 3-fold increase in polyp recurrence in the placebo group. Patients below 70 years of age and those with left-sided colonic adenomas or advanced adenomas responded better to folic acid supplementation.

CONCLUSION: High dose folic acid supplementation is associated with a significant reduction in the recurrence of colonic adenomas suggesting that folic acid may be an effective chemopreventive agent for colorectal neoplasia.

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Selenium: supplementation may prevent the development of adenomatous polyps.

American Journal of Gastroenterology 2002; 97: 2103-2108

OBJECTIVE: Selenium is a fundamental nutrient to human health that might have anticarcinogenic effects. Previous studies have assessed the possible relationship of selenium status to colorectal adenomas with controversial results. We primarily aimed to assess the relationship of serum selenium status with the presence of large size colorectal adenomas in subjects living in a poor selenium region. The serum selenium status in colorectal cancer was also evaluated.

METHODS: Serum selenium levels were measured in 28 patients with large size sporadic adenomatous polyps, 24 patients with colorectal adenocarcinomas, and 35 age-matched healthy individuals. A logistic regression analysis was performed to assess the relationship of serum selenium to colorectal adenomatous polyps after adjusting for confounding variables (age, sex, smoking habit, and alcohol drinking).

RESULTS: Among subjects aged 60 yr, mean serum selenium levels were significantly lower in both patient groups (adenoma, 57.9 4.3 g/L; cancer, 43.7 6.6 g/L) than in healthy controls (88.9 8 g/L) (p = 0.0001). There were no difference among subjects >60 yr old. A significant inverse association between selenium status and the diagnosis of large size adenomatous polyps after adjusting for confounding variables was found (adjusted p = 0.029). Subjects with higher selenium status (75th percentile value of 82.11 g/L) had a lower probability (OR = 0.17, 95% CI = 0.03–0.84) to be in the adenoma group than subjects with lower selenium status (<82.11 g/L). This association was more marked in subjects aged 60 yr (adjusted p value = 0.04, OR = 0.08, 95% CI = 0.007–0.91), and was not significant in older subjects.

CONCLUSIONS: Results suggest that high selenium status may decrease the risk of large size adenomas in a low selenium region, and that this preventive effect seems to be exclusive to subjects 60 yr. These results will need to be confirmed in additional epidemiological studies before recommending selenium supplementation in patients with colon adenomas.

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Vitamin B2: high levels appear to be protective against adenomatous polyps.

Cancer Epidemiology Biomarkers and Prevention 2008; 17: 2136-2145

Background: Folate, other vitamin B cofactors, and genes involved in folate-mediated one-carbon metabolism all may play important roles in colorectal neoplasia. In this study, we examined the associations between dietary and circulating plasma levels of vitamins B2, B6, and B12 and risk colorectal adenomas.

Methods: The Aspirin/Folate Polyp Prevention Study is a randomized clinical trial of folic acid supplementation and incidence of new colorectal adenomas in individuals with a history of adenomas (n = 1,084). Diet and supplement use were ascertained through a food frequency questionnaire administered at baseline. Blood collected at baseline was used to determine plasma B-vitamin levels. We used generalized linear regression to estimate risk ratios (RR) and 95% confidence intervals (95% CI) as measures of association.

Results: We found a borderline significant inverse association with plasma B6

[pyridoxal 5′-phosphate (PLP)] and adenoma risk (adjusted RR Q4 versus Q1, 0.78; 95% CI, 0.61-1.00; Ptrend = 0.08). This association was not modified by folic acid supplementation or plasma folate. However, the protective association of PLP with adenoma risk was observed only among subjects who did not drink alcohol (Pinteraction = 0.03). Plasma B2 (riboflavin) was inversely associated with risk of advanced lesions (adjusted RR Q4 versus Q1, 0.51; 95% CI, 0.26-0.99; Ptrend = 0.12). No significant associations were observed between adenoma risk and plasma vitamin B12 or dietary intake of vitamin B2

and B6. When we examined specific gene-B-vitamin interactions, we observed a possible interaction between methylenetetrahydrofolate reductase -C677T and plasma B2 on risk of all adenomas.

Conclusion: Our results suggest that high levels of PLP and B2 may protect against colorectal adenomas. (Cancer Epidemiol Biomarkers Prev2008;17(8):2136–45)

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Vitamin B6: Vitamin B6 levels associated with a decreased risk of colorectal cancer.

Journal of the American Medical Association 2010; 303: 1077-1083

Context Mounting evidence indicates that vitamin B6, a coenzyme involved in nearly 100 enzymatic reactions, may reduce the risk of colorectal cancer.Objective To conduct a systematic review with meta-analysis of prospective studies assessing the association of vitamin B6 intake or blood levels of pyridoxal 5′-phosphate (PLP; the active form of vitamin B6) with risk of colorectal cancer.Data Sources Relevant studies were identified by a search of MEDLINE and EMBASE databases to February 2010, with no restrictions. We also reviewed reference lists from retrieved articles.Study Selection We included prospective studies that reported relative risk (RR) estimates with 95% confidence intervals (CIs) for the association between vitamin B6 intake or blood PLP levels and the risk of colorectal, colon, or rectal cancer.Data Extraction Two authors independently extracted data and assessed study quality. Study-specific RRs were pooled using a random-effects model.Data Synthesis Nine studies on vitamin B6 intake and 4 studies on blood PLP levels were included in the meta-analysis. The pooled RRs of colorectal cancer for the highest vs lowest category of vitamin B6 intake and blood PLP levels were 0.90 (95% CI, 0.75-1.07) and 0.52 (95% CI, 0.38-0.71), respectively. There was heterogeneity among studies of vitamin B6 intake (P = .01) but not among studies of blood PLP levels (P = .95). Omitting 1 study that contributed substantially to the heterogeneity among studies of vitamin B6 intake yielded a pooled RR of 0.80 (95% CI, 0.69-0.92). The risk of colorectal cancer decreased by 49% for every 100-pmol/mL increase (approximately 2 SDs) in blood PLP levels (RR, 0.51; 95% CI, 0.38-0.69).

Conclusion Vitamin B6 intake and blood PLP levels were inversely associated with the risk of colorectal cancer in this meta-analysis.

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Vitamin D: intake of Vitamin D is associated with a 50% lower risk of developing colorectal cancer.

Journal of Steroid Biochemistry & Molecular Biology 2005; 97: 179-194

BackgroundInadequate photosynthesis or oral intake of Vitamin D are associated with high incidence rates of colorectal cancer, but the dose–response relationship has not been adequately studied.

MethodsDose–response gradients from observational studies of Vitamin D intake and serum 25-hydroxyvitamin D were plotted as trend lines. The point on each linear trend line corresponding to an odds ratio of 0.50 provided the prediagnostic Vitamin D intake or 25-hydroxyvitamin D concentration associated with 50% lower risk compared to <100 IU/day Vitamin D or <13 ng/ml serum 25-hydroxyvitamin D. Medians of these values were determined.

ResultsOverall, individuals with ≥1000 IU/day oral Vitamin D (p < 0.0001) or ≥33 ng/ml (82 nmol/l) serum 25-hydroxyvitamin D (p < 0.01) had 50% lower incidence of colorectal cancer compared to reference values.

ConclusionsIntake of 1000 IU/day of Vitamin D, half the safe upper intake established by the National Academy of Sciences, was associated with 50% lower risk. Serum 25-hydroxyvitamin D of 33 ng/ml, which is known to be safe, also was associated with 50% lower risk. Prompt public health action is needed to increase intake of Vitamin D3 to 1000 IU/day, and to raise 25-hydroxyvitamin D by encouraging a modest duration of sunlight exposure.

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Curcumin: possesses anti-cancer activity & potentiates the effect of chemotherapy in colon and other cancers.

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AbstractThe most practical approach to reduce the morbidity and mortality of cancer is to delay the process of carcinogenesis through the use of chemopreventive agents. This necessitates that safer compounds, especially those derived from natural sources must be critically examined for chemoprevention. A spice common to India and the surrounding regions, is tur- meric, derived from the rhizome of Curcuma longa. Pre-clinical studies in a variety of cancer cell lines including breast, cervical, colon, gastric, hepatic, leukemia, oral epithelial, ovarian, pancreatic, and prostate have consistently shown that curcumin possesses anti-cancer activity in vitro and in pre-clinical animal models. The robust activity of curcumin in colo- rectal cancer has led to five phase I clinical trials being completed showing the safety and tolerability of curcumin in colo- rectal cancer patients. To date clinical trials have not identified a maximum tolerated dose of curcumin in humans with clinical trials using doses up to 8000 mg per day. The success of these trials has led to the development of phase II trials that are currently enrolling patients. Overwhelming in vitro evidence and completed clinical trials suggests that curcumin may prove to be useful for the chemoprevention of colon cancer in humans. This review will focus on describing the pre- clinical and clinical evidence of curcumin as a chemopreventive compound in colorectal

cancer. Published by Elsevier Ireland Ltd.

Cancer Letters 225 (2007) 170-181

Dosages Matter

The Colon Vitamin Dose% DV (Daily Value)

Typical Multi-vitamin Dose%DV (Daily Value)

Micronutrients

Vitamin B2 3 mg, 176% 1.1 mg, 65%

Vitamin B6 3 mg, 150% 2 mg, 100%

Folate 500 mcg, 125% 400 mcg, 100%

Calcium 800 mcg, 80% 500 mg, 50%

Antioxidants

Beta Carotene 8,500 IU, 170% (Vitamin A) 1,014 IU, 20%

Vitamin D 1,000 IU, 250% 800 IU, 200%

Selenium 100 mcg, 143% 55 mcg, 79%

Curcumin 25 mg 0

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Delivering the right dosages to the right place at the right time

White tablet releases calcium at a pH of 7.0 thusdelivering the calcium directly to the colon whereit can bind with fatty acids and bile acids in the colon*

Yellow tablet releases all of the other ingredientsinto the small intestine where they are absorbedinto the bloodstream to effect their benefit

* Patent-pending formula. Developed by Dr. Frank Farrell, a gastroenterologist,to promote colon health. He has been in clinical practice for nearly two decadesand is a Fellow of the American Gastroenterological Association.

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Summary

Contains micronutrients and antioxidants that have been shown in scientific studies to promote colon health.*

Contains research-based dosages to deliver more effective benefits.

Has a unique patent-pending delivery mechanism (SynerGI-

dosing®) to deliver the right ingredients to the right place at the right time.

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Developed by a gastroenterologist who is well aware of the need and the scientific research to create the solution.

For Endoscopy Centers & ASCs:

Ask for your free Patient Introductory Kit• 50 cards redeemable for free 1-month supply

• Attractive display stand• Educational brochure

Contact DrFarrell@TheColonVitamin.com

Here’s to your patients’ colon health!

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.