ConsumptionNCT05861076
Moringa Powder Acceptability Trial Among Healthy Adults
A study testing Moringa Powder - Low Dose, Moringa Powder - Medium Dose and Moringa Powder - High Dose in people with Consumption and Acceptability, run by University of California, Berkeley at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Consumption, Acceptability, Side Effect
- What is being tested?
- Moringa Powder - Low Dose, Moringa Powder - Medium Dose and Moringa Powder - High Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults (18-65 y old)
- University of California (UC) Berkeley staff
- able to communicate in English or Spanish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
Berkeley, California, 94720
About this study
The study is a randomized acceptability trial involving the provision of three different doses of Moringa powder to be consumed daily by study participants.
Read the 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.
- Conditions
- Consumption, Acceptability, Side Effect
- Being tested
- Moringa Powder - Low Dose, Moringa Powder - Medium Dose, Moringa Powder - High Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa Powder - Low DoseOther
1 teaspoon Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days
Moringa Powder - Medium DoseOther
2 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days
Moringa Powder - High DoseOther
3 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Moringa Powder - Medium Dose | Experimental | Group A Receives: Other: Moringa Powder - Medium Dose |
| Moringa Powder - High Dose | Experimental | Group B Receives: Other: Moringa Powder - High Dose |
| Moringa Powder - Low Dose | Experimental | Group C Receives: Other: Moringa Powder - Low Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption
Total number of days that moringa powder was consumed
Measured: 7 days
Acceptability
Total acceptability score, in a scale from 3 to 15 points, with higher scores indicating greater acceptance
Measured: 7 days
Side effects
Total number of side effects reported
Measured: 7 days
Secondary outcomes (1)
Daily dose consumed
Average number of teaspoons consumed (among days when consumption was reported)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start3 Jan 2023
- Primary completion11 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Susana Matias, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861076
- Sponsor's protocol ID
- 2022-10-15659
- Status last verified
- Dec 2024
- First submitted
- 5 May 2023
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35010932Leone 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.
PubMed 30322091Stohs 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.
PubMed 25808883
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moringa Powder Acceptability Trial Among Healthy Adults
- ClinicalTrials.gov ID
- NCT05861076
- Acronym / sponsor ID
- 2022-10-15659
- Conditions
- Consumption, Acceptability, Side Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moringa Powder - Medium Dose | Experimental | Other: Moringa Powder - Medium DoseGroup A |
| Moringa Powder - High Dose | Experimental | Other: Moringa Powder - High DoseGroup B |
| Moringa Powder - Low Dose | Experimental | Other: Moringa Powder - Low DoseGroup C |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults (18-65 y old)
- University of California (UC) Berkeley staff
- able to communicate in English or Spanish
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moringa Powder - Low Dose1 teaspoon Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days | Other | Moringa Powder - Low Dose |
| Moringa Powder - Medium Dose2 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days | Other | Moringa Powder - Medium Dose |
| Moringa Powder - High Dose3 teaspoons Moringa leaf powder to be consumed with usual food and/or drinks daily for 7 days | Other | Moringa Powder - High Dose |
Primary outcome
Consumption
Time frame: 7 days
Total number of days that moringa powder was consumed
Acceptability
Time frame: 7 days
Total acceptability score, in a scale from 3 to 15 points, with higher scores indicating greater acceptance
Side effects
Time frame: 7 days
Total number of side effects reported
1 secondary outcome
Daily dose consumed
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Background: PubMed 35010932Gomez-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.
- Background: PubMed 30322091Leone 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.
- Background: PubMed 25808883Stohs 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.
- Stohs SJ, Hartman MJ. (2015). Review of the Safety and Efficacy of Moringa oleifera.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Consumption
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
Effects of a Hemp Seed-based Product on Appetite and Health Parameters
Healthy
Recruiting
Effects of Dietary Supplements on Muscle Mass and Function While Using GLP-1 Medication
Obesity & Overweight, Muscle Mass and Strength
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana Matias, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moringa Powder - Low Dose, Moringa Powder - Medium Dose and Moringa Powder - High Dose in people with Consumption and Acceptability, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05861076, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.