NCT05861076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

May 5, 2023

Last Update Submit

December 30, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Daily dose consumed

    7 days

Other Outcomes (5)

  • Change in skin carotenoids

    7 days

  • Taste

    7 days

  • Texture

    7 days

  • +2 more other outcomes

Study Arms (3)

Moringa Powder - Medium Dose

EXPERIMENTAL

Group A

Other: Moringa Powder - Medium Dose

Moringa Powder - High Dose

EXPERIMENTAL

Group B

Other: Moringa Powder - High Dose

Moringa Powder - Low Dose

EXPERIMENTAL

Group C

Other: Moringa Powder - Low Dose

Interventions

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

Moringa Powder - Low Dose

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

Moringa Powder - Medium Dose

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

Moringa Powder - High Dose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults (18-65 y old)
  • University of California (UC) Berkeley staff
  • able to communicate in English or Spanish

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California

Berkeley, California, 94720, United States

Location

Related Publications (3)

  • 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.

    PMID: 35010932BACKGROUND
  • 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.

    PMID: 30322091BACKGROUND
  • 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.

    PMID: 25808883BACKGROUND

Related Links

Study Officials

  • Susana Matias, PhD

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 16, 2023

Study Start

January 3, 2023

Primary Completion

May 11, 2023

Study Completion

May 30, 2023

Last Updated

January 1, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations