Clinical trial NCT05861076: Moringa Powder Acceptability Trial Among Healthy Adults
Official title: Moringa Powder Acceptability Trial Among Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Consumption
Acceptability
Side Effect
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: University of California, Davis
First posted: 2023-05-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Consumption
timeFrame: 7 days
measure: Acceptability
timeFrame: 7 days
measure: Side effects
timeFrame: 7 days
Secondary outcomes:
measure: Daily dose consumed
timeFrame: 7 days
Other outcomes:
measure: Change in skin carotenoids
timeFrame: 7 days
measure: Taste
timeFrame: 7 days
measure: Texture
timeFrame: 7 days
measure: Visual appearance
timeFrame: 7 days
measure: Willingness to continue
timeFrame: 7 days
Locations:
city: Berkeley
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, Berkeley
name: Susana Matias, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.