Generating Health Evidence From Dietary Supplementation With a Micro-vegetable Blend

April 29, 2026 updated by: University of Exeter

Large-Scale, Sustainable, Nutrient-Dense MicroVeg: Generating Health Evidence & Production Capacity to Support Incorporation Into UK Diet

Micro-vegetables (MV) are seedlings of larger vegetables. They can be grown quickly and are a concentrated source of micronutrients. MV are thought to have broad health benefits, including many inflammatory conditions. These include metabolic, cardiovascular, and cognitive diseases. This could have important implications for the health of an ageing UK population. Less than a third of British adults consume 5 portions of fruit and vegetables per day; this is the level that reduces risk of morbidity and mortality. Vegetables, including MV may - at least in part - exert their health effects by changing the level and type of bacteria in the mouth and gut. Despite their promise, the MV scientific literature is not yet extensive enough to support definitive health claims. It requires the addition of high-quality studies that are relevant to humans. This study will firstly investigate the anti-inflammatory effects on skeletal muscle and adipose tissue in older adults, using a proteomics approach. Second, this study will assess concentrations of circulating inflammatory markers in the sera collected from participants at baseline and at the conclusion of a 6-week period. Further, this study will describe the effects of six weeks MV consumption on cognition, and the oral and gut microbiome. As the bioactive compounds in the MV are owed to the potential beneficial effects for human health, these will be characterised in sera collected from participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • Devon
      • Exeter, Devon, United Kingdom, EX1 2LU
        • Public Health and Sports Sciences, University of Exeter

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 60 years and above
  • Body mass index > 25kg/m2
  • Able to give written informed consent to participate in the study

Exclusion Criteria:

  • Not meeting any inclusion criteria
  • Have had an adverse reaction to a local anaesthetic in the past
  • Hepatitis B, Hepatitis C or HIV positive
  • Have a bleeding disorder or are regularly taking a medication that will impair their blood's capacity to clot (e.g., aspirin, clopidogrel, warfarin, heparin)
  • Have had a severe adverse reaction to plasters
  • Have a gastrointestinal disorder that may impair the absorption of the supplement from the gastrointestinal tract
  • Have an autoimmune condition
  • Have a diagnosed neurocognitive disorder
  • Have a skin condition that is likely to increase the risk of infection at the biopsy site
  • Frequent use of medication or recreational drugs likely to affect our results
  • Recent infection or vaccination
  • Known allergy to any vegetables
  • Participated in a nutrition supplementation study in the last month

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Dietary supplement: Placebo
The intervention in this study is 6 weeks with a placebo supplement
Experimental: Micro-vegetable blend
Dietary supplement: Micro-vegetable blend
The intervention in this study is 6 weeks with a daily proprietary blend micro-vegetables that has been freeze-dried

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tandem Mass Tag (TMT) global proteomics
Time Frame: Adipose and skeletal muscle sampling at baseline and 6-week post-intervention
Characterisation of the proteome - hypothesis free
Adipose and skeletal muscle sampling at baseline and 6-week post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concentration of broad panel of inflammatory cytokines
Time Frame: Blood sample collected at baseline and 6-week post-intervention
Using multiplex immunoassay including but not limited to TNFα, IL-6, IL-10 and IL-1β, MIP1α, Galectin 1, Chemerin, Eotaxin, gp130, MCP-1, IL-7, MIP3α, IL-15, Aggrecan, Resistin, Leptin, MIP1β, MMP-1, MMP-3, MMP-13, and FABP4
Blood sample collected at baseline and 6-week post-intervention
Concentration of circulating bioactive components
Time Frame: Blood sample collected at baseline and 6-week post-intervention
Characterisation of bioactive components, including but not limited to polyphenols
Blood sample collected at baseline and 6-week post-intervention
Microbiome
Time Frame: Faecal and saliva collected at baseline and 6-week post-intervention
Metagenomic sequencing. Exploratory outcome to establish reference data for Shannon H diversity index and Chao1 species richness
Faecal and saliva collected at baseline and 6-week post-intervention
Simple Reaction Time
Time Frame: 5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Assessment of alertness and focused attention
5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Digit Vigilance
Time Frame: 5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Assessment of sustained and intensive attention
5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Choice Reaction Time
Time Frame: 5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Accompanied with Simple Reaction Time and records additional time taken to execute appropriate response
5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Pattern Separation
Time Frame: 5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Assessment of ability to store and retrieve visual information
5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Exeter

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Advanced Growers Limited
Ecog Pro Limited

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4331899

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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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