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| Name | Class |
|---|---|
| Lambda Therapeutic Research Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mulberry fruit extract | Experimental | 1.5 g of mulberry fruit powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water |
|
| Mulberry leaf extract | Experimental | 1.0 g of mulberry leaf powdered extract mixed into aa bowl containing 60 g of extruded rice + 300 ml of boiling water |
|
| White bean extract | Experimental | 3 g of white bean powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water |
|
| Apple extract | Experimental | 2 g of apple powdered extract standardized in phloridzin mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water |
|
| Elderberry extract | Experimental | 2 g of elderberry powder extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water |
|
| Turmeric extract |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mulberry fruit | Other |
| ||
| Mulberry leaf |
| Measure | Description | Time Frame |
|---|---|---|
| Post-prandial blood glucose | Glucose concentration in venous plasma | Positive incremental Area under the glucose versus time Curve between 0 (before) and 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | Fifteen minutes before (basal) and 65, 125, 185, 245, 305, 365 and 425 minutes after the ingestion of the test products |
| Measure | Description | Time Frame |
|---|---|---|
| Post-prandial serum insulin | Post-prandial serum insulin Area under versus time curves | Total Area under the insulin versus time Curve 0-2 hours after the intake. |
| Glucose in urine | Glucose in urine was measured using dipsticks with a detection limit of 2.28 mmol/L |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Mela, Dr. | Unilever R&D Vlaardingen (retired) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lambda Therapeutics Research Ttd | Ahmedabad | Gujarat | 382481 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32647531 | Derived | Mela DJ, Cao XZ, Dobriyal R, Fowler MI, Lin L, Joshi M, Mulder TJP, Murray PG, Peters HPF, Vermeer MA, Zhang Z. The effect of 8 plant extracts and combinations on post-prandial blood glucose and insulin responses in healthy adults: a randomized controlled trial. Nutr Metab (Lond). 2020 Jul 6;17:51. doi: 10.1186/s12986-020-00471-x. eCollection 2020. |
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| ID | Term |
|---|---|
| C000723317 | Morus alba |
| C000713810 | elderberry extract |
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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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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Randomization was generated by the bio-statistician CRO. Subjects and key study team personnel were blinded as much as possible with regard to the identification of specific treatments but their distinctive colors, flavors or tastes could not be masked.
To ensure the study team was not apparently aware of the treatments being administered to subjects, persons who were involved in the preparation of test products were not involved in rest of the study.
The sponsors team was blinded.
| Experimental |
0.18 g of curcumin powdered extract mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water |
|
| Turmeric extract + Apple extract | Experimental | 0.18 g of curcumin powdered extract + 2 g of apple powdered extract standardized in phloridzin mixed into a bowl containing 60 g of extruded rice + 300 ml of boiling water |
|
| Turmeric extract + Elderberry extract | Experimental | 0.18 g of curcumin powdered extract + 2 g of elderberry powder extract mixed into aa bowl containing 60 g of extruded rice + 300 ml of boiling water |
|
| Rice porridge control | Placebo Comparator | Bowl containing 60 g of extruded rice + 300 ml of boiling water |
|
|
| White bean | Other |
|
| Apple | Other |
|
| Elderberry | Other |
|
| Turmeric | Other |
|
| Rice porridge | Other |
|
| 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. |
| 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). | 24 hours before study product intake, during 7 hour the test day and in the 17 hours after the test day (telephone interview). |
| 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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |