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

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: Recruiting
• Conditions: Inflammation
• Intervention / Treatment: Dietary supplement: Micro-vegetable blend; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary O'Leary; Phone Number: 01392 724759; Email: M.OLeary@exeter.ac.uk
• Study Contact Backup: Name: Cealan Henry; Email: c.henry3@exeter.ac.uk

Study Locations

• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX1 2LU
      • Recruiting
      • Public Health and Sports Sciences, University of Exeter
      • Contact: Cealan Henry; Email: c.henry3@exeter.ac.uk

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Tandem Mass Tag (TMT) global proteomics	Characterisation of the proteome - hypothesis free	Adipose and skeletal muscle sampling at baseline and 6-week post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Faecal and saliva collected at baseline and 6-week post-intervention
Simple Reaction Time	Assessment of alertness and focused attention	5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Digit Vigilance	Assessment of sustained and intensive attention	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	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	5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)

Collaborators and Investigators

• Sponsor: University of Exeter
• Collaborators: Advanced Growers Limited; Ecog Pro Limited

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID 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