Moringa Powder Acceptability Trial Among Healthy Adults

December 30, 2024 updated by: University of California, Berkeley
The study is a randomized acceptability trial involving the provision of three different doses of Moringa powder to be consumed daily by study participants.

Study Overview

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

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Berkeley, California, United States, 94720
        • University of California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susana Matias, PhD, University of California, Berkeley

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2023

Primary Completion (Actual)

May 11, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

December 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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