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

NCT ID: NCT06384690

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Micro-vegetable blend

Group Type EXPERIMENTAL

Micro-vegetable blend

Intervention Type DIETARY_SUPPLEMENT

The intervention in this study is 6 weeks with a daily proprietary blend micro-vegetables that has been freeze-dried

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Micro-vegetable blend

The intervention in this study is 6 weeks with a daily proprietary blend micro-vegetables that has been freeze-dried

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

* 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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Advanced Growers Limited

UNKNOWN

Sponsor Role collaborator

Ecog Pro Limited

UNKNOWN

Sponsor Role collaborator

University of Exeter

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Public Health and Sports Sciences, University of Exeter

Exeter, Devon, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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4331899

Identifier Type: -

Identifier Source: org_study_id