2.2. Study Design
DSM Nutritional Products
This study was a three-arm, double-blinded randomized controlled trial (RCT). Ninety study participants were randomly assigned to one of three treatment arms: (1) 3 mg/day β-cryptoxanthin for 8 weeks, (2) 6 mg/day β-cryptoxanthin for 8 weeks, and (3) placebo. β-cryptoxanthin (3 mg) formulated in 15% corn oil with 1% dl-alpha-tocopherol were packaged in soft gel capsules and was provided as one 3 mg capsule and one placebo, two 3 mg capsules and 2 placebo capsules, respectively. The capsules were manufactured by DSM Nutritional Products. The placebo consisted of identical soft gel capsules without β-cryptoxanthin. A sample size of 90 subjects, accounting for an expected drop-out rate of approximately 15%, has 80% power to detect a difference of 0.8 standard deviations on β-cryptoxanthin concentration with alpha = 0.05. The randomization codes were generated using “blockrand” R package [