Moringa Powder Acceptability Trial Among Healthy Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Moringa Powder Acceptability Trial Among Healthy Adults

Conditions
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Side Effect, Consumption, Acceptability

Intervention / Treatment
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* Other: Moringa Powder - Low Dose
* Other: Moringa Powder - Medium Dose
* Other: Moringa Powder - High Dose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moringa Powder - Medium Dose<br>Group A | Other: Moringa Powder - Medium Dose<br>* 2 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days<br>|
| Experimental: Moringa Powder - High Dose<br>Group B | Other: Moringa Powder - High Dose<br>* 3 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days<br>|
| Experimental: Moringa Powder - Low Dose<br>Group C | Other: Moringa Powder - Low Dose<br>* 1 teaspoon Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily dose consumed | Average number of teaspoons consumed (among days when consumption was reported) | 7 days |