- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05861076
Moringa Powder Acceptability Trial Among Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Berkeley, California, United States, 94720
- University of California
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Moringa Powder - Medium Dose
Group A
|
2 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days
|
|
Experimental: Moringa Powder - High Dose
Group B
|
3 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days
|
|
Experimental: Moringa Powder - Low Dose
Group C
|
1 teaspoon Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Side effects
Time Frame: 7 days
|
Total number of side effects reported
|
7 days
|
|
Consumption
Time Frame: 7 days
|
Total number of days that moringa powder was consumed
|
7 days
|
|
Acceptability
Time Frame: 7 days
|
Total acceptability score, in a scale from 3 to 15 points, with higher scores indicating greater acceptance
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily dose consumed
Time Frame: 7 days
|
Average number of teaspoons consumed (among days when consumption was reported)
|
7 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Willingness to continue
Time Frame: 7 days
|
Proportion who indicate willingness to continue consuming moringa powder
|
7 days
|
|
Taste
Time Frame: 7 days
|
Average taste score (possible scores range is 1-3, with higher scores indicating greater acceptance)
|
7 days
|
|
Texture
Time Frame: 7 days
|
Average texture score (possible scores range is 1-3, with higher scores indicating greater acceptance)
|
7 days
|
|
Visual appearance
Time Frame: 7 days
|
Average visual appearance score (possible scores range is 1-3, with higher scores indicating greater acceptance)
|
7 days
|
|
Change in skin carotenoids
Time Frame: 7 days
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Susana Matias, PhD, University of California, Berkeley
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022-10-15659
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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