Moringa Powder Acceptability Trial Among Healthy Adults

Side Effect Clinical Trial

Official title:

Moringa Powder Acceptability Trial Among Healthy Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05861076
• Other study ID #: 2022-10-15659
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: November 2023
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a randomized acceptability trial involving the provision of three different doses of Moringa powder to be consumed daily by study participants.

Description:

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: - Consumption (measured by self-report and skin carotenoid level, as a biomarker of consumption of fruits and vegetables) - Acceptability (measured by rating the taste of the moringa powder when consumed with foods/drinks) - Safety (measured by self-report of any potential side effects, such as digestive issues due to fiber content) Results from this trial will suggest an acceptable dose in a population not yet diagnosed with a specific disease (e.g. diabetes) and therefore potentially less willing to consume it in doses that could make taste a potential barrier for consumption.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acceptability
• Consumption
• Side Effect

Intervention

Other:
• Moringa Powder - Low Dose
1 teaspoon Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days
• Moringa Powder - Medium Dose
2 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days
• Moringa Powder - High Dose
3 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days

Locations

Country	Name	City	State
United States	University of California	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Berkeley	University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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

External Links

•   Gomez-Martinez S, et.al. (2021). Moringa oleifera Leaf Supplementation as a Glycemic Control Strategy in Subjects with Prediabetes.
•   Leone A, et. al. (2018). 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;
•   Stohs SJ, Hartman MJ. (2015). Review of the Safety and Efficacy of Moringa oleifera.