Moringa Powder Acceptability Trial Among Healthy Adults

NCT ID: NCT05861076

Last Updated: 2025-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2023-05-30

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.

Conditions

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Consumption Acceptability Side Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Moringa Powder - Medium Dose

Group A

Group Type EXPERIMENTAL

Moringa Powder - Medium Dose

Intervention Type OTHER

2 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days

Moringa Powder - High Dose

Group B

Group Type EXPERIMENTAL

Moringa Powder - High Dose

Intervention Type OTHER

3 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days

Moringa Powder - Low Dose

Group C

Group Type EXPERIMENTAL

Moringa Powder - Low Dose

Intervention Type OTHER

1 teaspoon Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days

Interventions

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Moringa Powder - Low Dose

1 teaspoon Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days

Intervention Type OTHER

Moringa Powder - Medium Dose

2 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days

Intervention Type OTHER

Moringa Powder - High Dose

3 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role collaborator

University of California, Berkeley

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susana Matias, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Locations

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University of California

Berkeley, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 35010932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30322091 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25808883 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6680322/

Stohs SJ, Hartman MJ. (2015). Review of the Safety and Efficacy of Moringa oleifera.

Other Identifiers

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2022-10-15659

Identifier Type: -

Identifier Source: org_study_id

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