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Completed

NCT Number: NCT06384690

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

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.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Health and Sports Sciences, University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Micro-vegetable blend

Dietary Supplement

The intervention in this study is 6 weeks with a daily proprietary blend micro-vegetables that has been freeze-dried

Placebo

Dietary Supplement

The intervention in this study is 6 weeks with a placebo supplement

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Advanced Growers Limited
  • Ecog Pro Limited

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 25, 2024
Registry last updated
Apr 30, 2026

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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