Side Effect Clinical Trial
Official title:
Moringa Powder Acceptability Trial Among Healthy Adults
Verified date | November 2023 |
Source | University of California, Berkeley |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a randomized acceptability trial involving the provision of three different doses of Moringa powder to be consumed daily by study participants.
Status | Active, not recruiting |
Enrollment | 52 |
Est. completion date | May 30, 2024 |
Est. primary completion date | May 11, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - adults (18-65 y old) - University of California (UC) Berkeley staff - able to communicate in English or Spanish Exclusion Criteria: - UC Berkeley students or academic employees - pregnant or lactating individuals - individuals who already consume Moringa regularly - individuals who have been told that they have diabetes or hypothyroidism - individuals who are taking any medication, with the exception of over-the-counter pain medication and contraceptives - individuals who follow a medically prescribed diet |
Country | Name | City | State |
---|---|---|---|
United States | University of California | Berkeley | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Berkeley | University of California, Davis |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | 7 days | |
Other | Taste | Average taste score (possible scores range is 1-3, with higher scores indicating greater acceptance) | 7 days | |
Other | Texture | Average texture score (possible scores range is 1-3, with higher scores indicating greater acceptance) | 7 days | |
Other | Visual appearance | Average visual appearance score (possible scores range is 1-3, with higher scores indicating greater acceptance) | 7 days | |
Other | Willingness to continue | Proportion who indicate willingness to continue consuming moringa powder | 7 days | |
Primary | Consumption | Total number of days that moringa powder was consumed | 7 days | |
Primary | Acceptability | Total acceptability score, in a scale from 3 to 15 points, with higher scores indicating greater acceptance | 7 days | |
Primary | Side effects | Total number of side effects reported | 7 days | |
Secondary | Daily dose consumed | Average number of teaspoons consumed (among days when consumption was reported) | 7 days |
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