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Completed

NCT Number: NCT05861076

Moringa Powder Acceptability Trial Among Healthy Adults

The study is a randomized acceptability trial involving the provision of three different doses of Moringa powder to be consumed daily by study participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California

Berkeley, California, 94720, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moringa Powder - Low Dose

Other

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

Moringa Powder - Medium Dose

Other

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

Moringa Powder - High Dose

Other

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

Primary outcomes

  1. Consumption

    Time frame: 7 days

    Total number of days that moringa powder was consumed

  2. Acceptability

    Time frame: 7 days

    Total acceptability score, in a scale from 3 to 15 points, with higher scores indicating greater acceptance

  3. Side effects

    Time frame: 7 days

    Total number of side effects reported

Secondary outcomes

  1. Daily dose consumed

    Time frame: 7 days

    Average number of teaspoons consumed (among days when consumption was reported)

Other outcomes

  1. 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.

  2. Taste

    Time frame: 7 days

    Average taste score (possible scores range is 1-3, with higher scores indicating greater acceptance)

  3. Texture

    Time frame: 7 days

    Average texture score (possible scores range is 1-3, with higher scores indicating greater acceptance)

  4. Visual appearance

    Time frame: 7 days

    Average visual appearance score (possible scores range is 1-3, with higher scores indicating greater acceptance)

  5. Willingness to continue

    Time frame: 7 days

    Proportion who indicate willingness to continue consuming moringa powder

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • University of California, Davis

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 16, 2023
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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