Identifying the Microbial Metabolome: The Missing Link Between Diet and Human Health

NCT07591961 | Completed

• 2 other identifiers: 15/HSMC/005U01CA179531
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is a lot of evidence to suggest that the bacteria in our gut play a major role in maintaining our health, but very little is known about the way in which this is achieved. In this study we will identify how the bacteria in out gut change the food we eat into products that may be responsible for this effect. We will also identify which bacteria are responsible for these changes. The foods we will look at are those suggested by the American Institute of Cancer Research to help prevent cancer; leafy green vegetables (cabbage, spinach), soft fruits (strawberry) cereal (oats) and plant-based protein (soya and pea). We will feed a diet rich in these foods to volunteers, monitoring the changes to the bacteria in our gut and the products produced. We will identify which products have potential to prevent cancer and also to work out how they are being produced. This work will provide new and important information that will allow us to understand more about the link between diet and health.

Conditions

Inflammation Gastrointestinal Tract

Keywords

Microbiome; Metabolome; Dietary Metabolites; Macronutrient Balance

Outcome Measures

Primary Outcomes (2)

• Gut Microbial Metabolites

  Wide range of beneficial and detrimental microbial metabolites in faeces, blood and urine

  At Day 3

• Gut Microbial Metabolites

  Wide range of beneficial and detrimental microbial metabolites in faeces, blood and urine

  At Day 5

Secondary Outcomes (2)

• Gut Microbial Species

  At Day 3

• Gut Microbial Species

  At Day 5

Study Arms (6)

oat

ACTIVE COMPARATOR

The intervention products will be commercially available oat provided as freeze dried powders baked into a bun.

Dietary Supplement: Food

pea

ACTIVE COMPARATOR

The intervention products will be commercially available pea provided as freeze dried powders baked into a bun.

Dietary Supplement: Food

soya

ACTIVE COMPARATOR

The intervention products will be commercially available soya provided as freeze dried powders baked into a bun.

Dietary Supplement: Food

strawberry

ACTIVE COMPARATOR

The intervention products will be commercially available strawberry provided as freeze dried powders. The product will be consumed as bread rolls, each containing 33.3 g of the intervention product. Three rolls will be consumed per day during the five day intervention period

Dietary Supplement: Food

spinach

ACTIVE COMPARATOR

The intervention products will be commercially available spinach provided as freeze dried powders baked into a bun.

Dietary Supplement: Food

kale

ACTIVE COMPARATOR

The intervention products will be commercially available kale provided as freeze dried powders baked into a bun.

Dietary Supplement: Food

Interventions

Food DIETARY_SUPPLEMENT

The intervention products will be consumed as bread rolls, each containing 33.3 g of the intervention product. Three rolls will be consumed per day during the five day intervention period, in addition to the prescribed low-phytochemical diet.

kale; oat; pea; soya; spinach; strawberry

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male or females
• aged between 18 and 55 years
• able to give informed consent.

You may not qualify if:

• are taking any medicines prescribed by their GP
• are taking drugs to lower high cholesterol levels or high blood pressure
• regularly take analgesics, antipyretic or anti-inflammatories
• regularly take nutritional supplements
• have taken antibiotics in the last three months
• have given a large blood donation in last three months

Sponsors & Collaborators

• University of Aberdeen: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Interventions

Food

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Wendy R Russell, PhD

  University of Aberdeen Rowett Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants receive five alternative interventions during the period of the study

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: May 18, 2026
• Study Start: May 23, 2016
• Primary Completion: August 30, 2019
• Study Completion: September 4, 2019
• Last Updated: May 18, 2026

Record last verified: 2020-02