Experimental design
The present study was a double-blind, placebo-controlled,
randomised, crossover clinical trial. After completing the
screening process, participants presented at 18.00 hours at
the Pennington inpatient unit for 5 d. At 18.30 hours, they
received a standardised dinner and, at 20.00 hours, a snack.
This provided 50 % of the basal energy requirement, calcu-
lated according to published equations(16). The macronutrient
composition of the diet was 50 % from carbohydrates, 30 %
from fat and 20 % from protein. At 21.00 hours, subjects
were interviewed for the occurrence of symptoms within the
last 12 hours(17). On the next day, in order to minimise
physical activity, subjects remained in their bed for the
entire duration of the RMR assessment. RMR was measured
for 45 min (baseline) before ingestion of twelve gel capsules
followed by another 120 min of RMR measurement. Doses
(placebo or capsinoids at 1, 3, 6 or 12 mg) were randomly
assigned using a randomised number sequence. Urine was
collected before and after the 165 min RMR measurement
for nitrogen excretion rate. Blood pressure and body tempera-
ture were measured at 2 50, 2 5, 60 and 120 min of capsules
ingestion. At the end of the 165 min RMR measurement,
occurrence of symptoms for the last 3 h was assessed accord-
ing to a symptoms’ checklist(17). Total body fat content was
measured by dual energy X-ray absorptiometry scan on one
of the mornings after RMR testing. Finally, 72 h after the
last testing day, subjects were contacted by phone and inter-
viewed for the presence of symptoms and adverse events.
Physical activity and consumption of tea, coffee and alcohol
were not permitted during the week of metabolic evaluation.