Clinical trial NCT06384690: Generating Health Evidence From Dietary Supplementation With a Micro-vegetable Blend
Official title: Large-Scale, Sustainable, Nutrient-Dense MicroVeg: Generating Health Evidence & Production Capacity to Support Incorporation Into UK Diet
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Inflammation
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Advanced Growers Limited
name: Ecog Pro Limited
First posted: 2024-04-25
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tandem Mass Tag (TMT) global proteomics
timeFrame: Adipose and skeletal muscle sampling at baseline and 6-week post-intervention
Secondary outcomes:
measure: Concentration of broad panel of inflammatory cytokines
timeFrame: Blood sample collected at baseline and 6-week post-intervention
measure: Concentration of circulating bioactive components
timeFrame: Blood sample collected at baseline and 6-week post-intervention
measure: Microbiome
timeFrame: Faecal and saliva collected at baseline and 6-week post-intervention
measure: Simple Reaction Time
timeFrame: 5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
measure: Digit Vigilance
timeFrame: 5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
measure: Choice Reaction Time
timeFrame: 5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
measure: Pattern Separation
timeFrame: 5 times throughout the intervention (baseline, week 2, week 4, week 6 and week 8)
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Public Health and Sports Sciences, University of Exeter
state: Devon
Study officials:
References: