Effects of gender, posture, and age on gastric residence time of an indigestible solid: pharmaceutical considerations.

We have recently reported the effect of varying food composition on the gastric residence time (GRT) of an indigestible solid, the Heidelberg capsule (HC). The purpose of the present evaluation was to evaluate the reproducibility and the effect of gender, posture, and age on the GRT of the HC. The reproducibility in measurement of the GRT of the Heidelberg capsule was evaluated in two trials separated by 1 week. Mean GRT values obtained in nine healthy men on day 1 were not statistically different from those on day 8 (3.5 +/- 0.6 vs 3.5 +/- 0.7 hr, P greater than 0.05). To evaluate the influence of gender on the GRT of the HC, 12 healthy male volunteers and 12 age (+/- 3 years)- and race-matched female counterparts entered into a randomized study. Each subject was served a standardized 500-kcal breakfast 30 min prior to oral ingestion of the HC. The mean (+/- SD) ambulatory GRT in the males was significantly faster than in the females (3.4 +/- 0.6 vs 4.6 +/- 1.2 hr, P less than 0.01). Influence of posture on the GRT of HC was examined in the same 12 men in a two-way, randomized, crossover study. The mean GRT for volunteers in the supine state was not statistically different from that in the upright, ambulatory state (3.4 +/- 0.8 vs 3.5 +/- 0.7 hr, P greater than 0.05). The effect of age on the GRT of the HC was evaluated in 12 healthy elderly males (greater than 65 years) with no prior gastrointestinal complications.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes