InflammationNCT06384690
Generating Health Evidence From Dietary Supplementation With a Micro-vegetable Blend
A study testing Micro-vegetable blend in people with Inflammation, run by University of Exeter at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Micro-vegetable blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2024to 31 Aug 2025
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60 years and above
- Body mass index > 25kg/m2
- Able to give written informed consent to participate in the study
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Public Health and Sports Sciences, University of Exeter
Exeter, Devon, EX1 2LU
About this study
Official title: 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.
- Conditions
- Inflammation
- Being tested
- Micro-vegetable blend, Placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-vegetable blendDietary supplement
The intervention in this study is 6 weeks with a daily proprietary blend micro-vegetables that has been freeze-dried
PlaceboDietary supplement
The intervention in this study is 6 weeks with a placebo supplement
| Study group | Role | What they receive |
|---|---|---|
| Micro-vegetable blend | Experimental | Not described Receives: Dietary Supplement: Micro-vegetable blend |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tandem Mass Tag (TMT) global proteomics
Characterisation of the proteome - hypothesis free
Measured: Adipose and skeletal muscle sampling at baseline and 6-week post-intervention
Secondary outcomes (7)
Concentration of broad panel of inflammatory cytokines
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
Measured: Blood sample collected at baseline and 6-week post-intervention
Concentration of circulating bioactive components
Characterisation of bioactive components, including but not limited to polyphenols
Measured: Blood sample collected at baseline and 6-week post-intervention
Microbiome
Metagenomic sequencing. Exploratory outcome to establish reference data for Shannon H diversity index and Chao1 species richness
Measured: Faecal and saliva collected at baseline and 6-week post-intervention
Simple Reaction Time
Assessment of alertness and focused attention
Measured: 5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Digit Vigilance
Assessment of sustained and intensive attention
Measured: 5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Choice Reaction Time
Accompanied with Simple Reaction Time and records additional time taken to execute appropriate response
Measured: 5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Pattern Separation
Assessment of ability to store and retrieve visual information
Measured: 5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Feb 2024
- Primary completion29 Oct 2024
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Growers Limited, Ecog Pro Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384690
- Sponsor's protocol ID
- 4331899
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large-Scale, Sustainable, Nutrient-Dense MicroVeg: Generating Health Evidence & Production Capacity to Support Incorporation Into UK Diet
- ClinicalTrials.gov ID
- NCT06384690
- Acronym / sponsor ID
- 4331899
- Conditions
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Advanced Growers Limited, Ecog Pro Limited
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 25 Apr 2024 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micro-vegetable blend | Experimental | Dietary Supplement: Micro-vegetable blend |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 60 years and above
- Body mass index > 25kg/m2
- Able to give written informed consent to participate in the study
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Micro-vegetable blendThe intervention in this study is 6 weeks with a daily proprietary blend micro-vegetables that has been freeze-dried | Dietary supplement | Micro-vegetable blend |
| PlaceboThe intervention in this study is 6 weeks with a placebo supplement | Dietary supplement | Placebo |
Primary outcome
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
7 secondary outcomes
Concentration of broad panel of inflammatory cytokines
Time frame: 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
Microbiome
Time frame: 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)
Digit Vigilance
Time frame: 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)
Pattern Separation
Time frame: 5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
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 30 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-vegetable blend in people with Inflammation, run by University of Exeter at 1 site in United Kingdom.
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 13 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 30 Apr 2026. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?
Tandem Mass Tag (TMT) global proteomics (time frame: Adipose and skeletal muscle sampling at baseline and 6-week post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2026.