Lambda Therapeutics Research Ttd
Ahmedabad, Gujarat, 382481, India
NCT Number: NCT04258501
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).
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Notify Me20 year–50 year
All sexes
Interventional
Not applicable
Ahmedabad, Gujarat, 382481, India
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Positive incremental Area under the glucose versus time Curve between 0 (before) and 2 hours.
Glucose concentration in venous plasma
Time frame: Fifteen minutes before (basal) and 65, 125, 185, 245, 305, 365 and 425 minutes after the ingestion of the test products
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: Ten minutes before (baseline) and at 130, 250, 370 and 420 minutes after the ingestion of the test products.
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: 24 hours before study product intake, during 7 hour the test day and in the 17 hours after the test day (telephone interview).
Stool consistency was evaluated by semi-quantitative Bristol scale (score between 1 = constipation and 7 = watery diarrhea).
Time frame: Total Area under the insulin versus time Curve 0-2 hours after the intake.
Post-prandial serum insulin Area under versus time curves
Time frame: Subjects were asked to empty their bladder before study product intake (-20 minutes) and again before leaving the site ( 450 minutes). In these two samples and in all additional urine samples voided while subjects were on site, glucose was analyzed
Glucose in urine was measured using dipsticks with a detection limit of 2.28 mmol/L
Unilever R&D
Industry
An Exploratory Study of Efficacy and Tolerance on Selected Natural Extracts, With the Potential of Reducing Post Prandial Blood Glucose Response, in Healthy Indian Adult Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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