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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
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The study is a randomized acceptability trial involving the provision of three different doses of Moringa powder to be consumed daily by study participants.
Moringa is a drought-resistant nutrient-dense tree with high concentrations of anti-inflammatory plant chemicals in its edible leaves and seeds. In preclinical studies Moringa has been shown to improve insulin resistance, dyslipidemia, and high blood pressure. But its effects in humans remain unclear. Moringa (20g leaf powder on two different days) supplementation decreased post-prandial glucose in Saharawi refugees with type 2 diabetes, compared to controls (Leone, et. al., 2018). In a randomized control trial in Spain, Moringa consumed as six daily capsules of dry leaf powder (2.4 g/day) for 12 weeks, significant decreased fasting blood glucose and glycated hemoglobin (HbA1c) among prediabetic subjects (Gomez-Martinez, et. al., 2021).
The investigators are conducting a testing trial of Moringa oleifera leaves, offered as powder, to be added to foods and/or drinks to test safety, acceptability and consumption of it in three different doses: 1 tsp, 2 tsp, and 3 tsp. Study participants will be randomly allocated to one of the three doses.
Among the studies that have been conducted with human subjects (individuals with diabetes), no adverse effects have been reported with whole leaf powder at up to a single dose of 50 g or using 8 g per day dose for 40 days (Stohs & Hartman, 2015).
The outcomes to be measured in this testing trial are the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moringa Powder - Medium Dose | Experimental | Group A |
|
| Moringa Powder - High Dose | Experimental | Group B |
|
| Moringa Powder - Low Dose | Experimental | Group C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moringa Powder - Low Dose | Other | 1 teaspoon Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Consumption | Total number of days that moringa powder was consumed | 7 days |
| Acceptability | Total acceptability score, in a scale from 3 to 15 points, with higher scores indicating greater acceptance | 7 days |
| Side effects | Total number of side effects reported | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Daily dose consumed | Average number of teaspoons consumed (among days when consumption was reported) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in skin carotenoids | Difference in skin carotenoid score from baseline to endline (score at endline minus score at baseline). Skin carotenoid levels are measured using the VeggieMeter. This measurement involves scanning a finger using a quick, non-invasive optical method that requires the participant to gently press a finger against a lens surface, with the help of a spring-loaded cover. Skin carotenoids are a biomarker for consumption of fruits and vegetables. A positive outcome value is expected as an indication of consumption of the Moringa powder. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susana Matias, PhD | University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Berkeley | California | 94720 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35010932 | Background | Gomez-Martinez S, Diaz-Prieto LE, Vicente Castro I, Jurado C, Iturmendi N, Martin-Ridaura MC, Calle N, Duenas M, Picon MJ, Marcos A, Nova E. Moringa oleifera Leaf Supplementation as a Glycemic Control Strategy in Subjects with Prediabetes. Nutrients. 2021 Dec 24;14(1):57. doi: 10.3390/nu14010057. | |
| 30322091 | Background |
| Label | URL |
|---|---|
| Stohs SJ, Hartman MJ. (2015). Review of the Safety and Efficacy of Moringa oleifera. | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 30, 2023 | Aug 2, 2023 | SAP_000.pdf |
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Baseline assessor will reveal the participants group, only after completing the baseline measurements. After provision of corresponding dosage (assignment), the group information will again be covered, per programming in the Excel file.
| Moringa Powder - Medium Dose | Other | 2 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days |
|
| Moringa Powder - High Dose | Other | 3 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days |
|
| 7 days |
| Taste | Average taste score (possible scores range is 1-3, with higher scores indicating greater acceptance) | 7 days |
| Texture | Average texture score (possible scores range is 1-3, with higher scores indicating greater acceptance) | 7 days |
| Visual appearance | Average visual appearance score (possible scores range is 1-3, with higher scores indicating greater acceptance) | 7 days |
| Willingness to continue | Proportion who indicate willingness to continue consuming moringa powder | 7 days |
| Leone A, Bertoli S, Di Lello S, Bassoli A, Ravasenghi S, Borgonovo G, Forlani F, Battezzati A. Effect of Moringa oleifera Leaf Powder on Postprandial Blood Glucose Response: In Vivo Study on Saharawi People Living in Refugee Camps. Nutrients. 2018 Oct 12;10(10):1494. doi: 10.3390/nu10101494. |
| 25808883 | Background | Stohs SJ, Hartman MJ. Review of the Safety and Efficacy of Moringa oleifera. Phytother Res. 2015 Jun;29(6):796-804. doi: 10.1002/ptr.5325. Epub 2015 Mar 24. |