Randomized, balanced, incomplete block design exploratory study of efficacy, with 8 active treatments (4 treatments per subject; 35 or 37 subjects per treatment) compared to a reference treatment (all 72 subjects).
Incomplete block design cross over study in which the subjects consumed commercial rice porridge (60 grams of extruded rice to which 300 ml of boiling water was added) in the morning in a fasted state. On each visit one of the seven different natural exacts was mixed into this porridge just before consumption. The reference was consumed by all subjects and consisted of plain porridge with no extract added.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
72
Lambda Therapeutics Research Ttd
Ahmedabad, Gujarat, India
Post-prandial blood glucose
Glucose concentration in venous plasma
Time frame: Positive incremental Area under the glucose versus time Curve between 0 (before) and 2 hours.
Breath hydrogen excretion
Hydrogen gas in exhaled breath. When a subject produced 10 ppm hydrogen or more above the basal breath hydrogen level the treatment was regarded as a "positive"
Time frame: Fifteen minutes before (basal) and 65, 125, 185, 245, 305, 365 and 425 minutes after the ingestion of the test products
Intestinal discomfort
An intestinal discomfort questionnaire was administered. The questionnaire asked whether subjects had experienced 1) flatulence, 2) nausea, 3) bloating or 4) pain in the bowels. Percentage of "Yes" scores was calculated per discomfort.
Time frame: Ten minutes before (baseline) and at 130, 250, 370 and 420 minutes after the ingestion of the test products.
Stool consistency and number of stools
Stool consistency was evaluated by semi-quantitative Bristol scale (score between 1 = constipation and 7 = watery diarrhea).
Time frame: 24 hours before study product intake, during 7 hour the test day and in the 17 hours after the test day (telephone interview).
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