Prior to a randomized controlled trial to prevent gastric cancer by oral supplementation of β β β β-carotene and vitamin C in a high-risk Japanese population, we examined the serum response to threemonth oral supplementation of β β β β-carotene (0, 3, 30 mg/day) and vitamin C (0, 50, 1000 mg/day) by a three-by-three factorial design using 54 subjects (age range = = = =40-69 years). Serum concentrations of carotenoids, α α α α-tocopherol, and ascorbic acid were examined at baseline, and one, two, and threemonth points. Both serum β β β β-carotene and ascorbic acid were significantly higher in high-dose groups than in each placebo group during the supplementation. The serum β β β β-carotene increased gradually (597-830% increase) during the study, whereas the serum ascorbic acid reached nearly a steady-state at the one-month point and remained stable thereafter (88-95% increase). No statistically significant interaction between β β β β-carotene and vitamin C supplementations was observed either for serum β β β β-carotene or for serum ascorbic acid. Among carotenoids and α α α α-tocopherol examined, serum lycopene in the high-dose β β β β-carotene group was significantly higher than in the placebo group at all points. No unfavorable change in carotenoids and α α α α-tocopherol was observed in any group.Key words: β-Carotene -Ascorbic acid -Supplements -Nutrient -Randomized controlled trial Gastric cancer has long been the most common cancer in Japan.1) Several epidemiologic studies have reported protective effects of high intake of β-carotene and vitamin C (ascorbic acid) and their high serum or plasma concentration levels against gastric cancer.2, 3) Vitamin C in fruits and vegetables is considered to be a preventative substance inhibiting nitrosamine formation and also acting as a free radical scavenger.2, 4) Atrophic gastritis is considered to be a precursor of intestinal-type gastric cancer. 5) A protective effect of β-carotene against the progression of atrophic gastritis has been reported.
6)Based on these findings, we planned a randomized controlled trial to test the preventative effect of oral β-carotene and vitamin C supplementation for a high-risk population, i.e., subjects with atrophic gastritis. 7) However, the effects of oral supplementation of β-carotene and vitamin C on the serum concentrations have not yet been established in Japanese populations. Prior to the study, we conducted a pilot study using subjects of a health check-up program to evaluate the effect of supplementation of β-carotene and vitamin C on the serum levels.
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MATERIALS AND METHODS
Study designThe study design has been reported elsewhere.8) Briefly, the subjects were recipients of a health check-up program in a local general hospital with chronic atrophic gastritis diagnosed on the basis of pepsinogen I less than 70 mg/ml and pepsinogen I/pepsinogen II ratio less then 3.0. The age ranged from 40 to 69 years. Among 90 subjects screened, 55 subjects, 35 men and 20 women, participated in the trial. The participants were randomly ass...