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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06384690
• Other study ID #: 4331899
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: University of Exeter
• Contact: Mary O'Leary
• Phone: 01392 724759
• Email: M.OLeary[@]exeter.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Public Health and Sports Sciences, University of Exeter	Exeter	Devon

Sponsors (3)

Lead Sponsor	Collaborator
University of Exeter	Advanced Growers Limited, Ecog Pro Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Concentration of broad panel of inflammatory cytokines	Using multiplex immunoassay including but not limited to TNFa, IL-6, IL-10 and IL-1ß, MIP1a, Galectin 1, Chemerin, Eotaxin, gp130, MCP-1, IL-7, MIP3a, IL-15, Aggrecan, Resistin, Leptin, MIP1ß, MMP-1, MMP-3, MMP-13, and FABP4	Blood sample collected at baseline and 6-week post-intervention
Secondary	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
Secondary	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
Secondary	Simple Reaction Time	Assessment of alertness and focused attention	5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Secondary	Digit Vigilance	Assessment of sustained and intensive attention	5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Secondary	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)
Secondary	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)