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

Not Applicable

Active, not recruiting

Interventions: Dietary Supplement: Placebo
Dietary Supplement: Micro-vegetable blend

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Micro-vegetable blend	Micro-vegetable blend	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Concentration of circulating bioactive components	Blood sample collected at baseline and 6-week post-intervention	Characterisation of bioactive components, including but not limited to polyphenols
Microbiome	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
Concentration of broad panel of inflammatory cytokines	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
Simple Reaction Time	5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)	Assessment of alertness and focused attention
Digit Vigilance	5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)	Assessment of sustained and intensive attention
Choice Reaction Time	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
Pattern Separation	5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)	Assessment of ability to store and retrieve visual information

Locations (1): Public Health and Sports Sciences, University of Exeter
🇬🇧
Exeter, Devon, United Kingdom