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

NCT06384690 | Completed

• 1 other identifier: 4331899
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Concentration of broad panel of inflammatory cytokines

  Blood sample collected at baseline and 6-week post-intervention

• Concentration of circulating bioactive components

  Blood sample collected at baseline and 6-week post-intervention

• Microbiome

  Faecal and saliva collected at baseline and 6-week post-intervention

• Simple Reaction Time

  5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)

• Digit Vigilance

  5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)

Study Arms (2)

Micro-vegetable blend

EXPERIMENTAL

Dietary Supplement: Micro-vegetable blend

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

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

Micro-vegetable blend

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead
• Advanced Growers Limited: collaborator
• Ecog Pro Limited: collaborator

Study Sites (1)

Public Health and Sports Sciences, University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 25, 2024
• Study Start: February 1, 2024
• Primary Completion: October 29, 2024
• Study Completion: August 31, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)