Acceptability, Consumption, Side Effect
Conditions
Brief 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.
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.
Interventions
OTHERMoringa Powder - Low Dose
1 teaspoon Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days
OTHERMoringa Powder - Medium Dose
2 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days
OTHERMoringa Powder - High Dose
3 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days
Sponsors
University of California, Davis
University of California, Berkeley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consumption | 7 days | Total number of days that moringa powder was consumed |
| Acceptability | 7 days | Total acceptability score, in a scale from 3 to 15 points, with higher scores indicating greater acceptance |
| Side effects | 7 days | Total number of side effects reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily dose consumed | 7 days | Average number of teaspoons consumed (among days when consumption was reported) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in skin carotenoids | 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. |
| Willingness to continue | 7 days | Proportion who indicate willingness to continue consuming moringa powder |
| Taste | 7 days | Average taste score (possible scores range is 1-3, with higher scores indicating greater acceptance) |
| Texture | 7 days | Average texture score (possible scores range is 1-3, with higher scores indicating greater acceptance) |
| Visual appearance | 7 days | Average visual appearance score (possible scores range is 1-3, with higher scores indicating greater acceptance) |
Countries
United States
Outcome results
None listed