Actively Recruiting

Phase Not Applicable
Age: 30Years - 70Years
All Genders
Healthy Volunteers
NCT07586111

Effects of Plant Foods on Gastrointestinal and Cardiometabolic Health

Led by King's College London · Updated on 2026-05-14

248

Participants Needed

1

Research Sites

135 weeks

Total Duration

On this page

Sponsors

K

King's College London

Lead Sponsor

B

Biotechnology and Biological Sciences Research Council

Collaborating Sponsor

AI-Summary

What this Trial Is About

The aim of this randomised controlled trial is to investigate the effects of plant foods on gastrointestinal and cardiometabolic health in healthy adults aged 30-70 years old. The main question it will answer is "what is the effect of plant foods on alpha-diversity of the gut microbiota?". Researchers will compare two diets containing plant foods to see if they have different effects on gastrointestinal and cardiometabolic health. Participants will be asked to replace all their meals, snacks and drinks with those provided by the study team for four weeks (6 days/week). Participants will also be asked to attend the research facility on three occasions to: * Provide a blood sample * Provide a urine sample * Provide a stool sample * Have their body composition assessed * Have an ultrasound of their artery (arm) * Have their blood pressure measured * Answer questionnaires related to dietary intake, mental health, physical activity, quality of life, diet acceptability and adherence

CONDITIONS

Official Title

Effects of Plant Foods on Gastrointestinal and Cardiometabolic Health

Who Can Participate

Age: 30Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 30 to 70 years
  • Ability to give informed consent in English
  • Consume equal or less than the average UK plant food intake in number and quantity
  • Consume less than 30 g of fiber per day
  • Body mass index (BMI) between 18.50 and 29.99 kg/m2
  • Willing to adhere to the diet intervention, complete questionnaires, and provide stool, urine, and blood samples
  • Willing to record weight, anthropometric values, and food intake during the study
  • Able to follow the diet protocol for the entire trial (including having freezer space and access to oven/microwave, no planned travel)
  • Willing to stop prebiotic and probiotic use 4 weeks before and during the intervention
  • Willing to consume animal products daily
  • Stable medication use if receiving hormone replacement therapy for the past 3 months
Not Eligible

You will not qualify if you...

  • Medical history of diabetes, major psychiatric conditions, current eating disorder, alcohol abuse, active cancer treatment in the past year, severe neurological, endocrine, renal, cardiac, pulmonary, or other chronic diseases
  • Severe oesophagitis, gastritis, duodenitis, active diverticulitis, intestinal or colonic strictures
  • Diagnosed Coeliac disease, Crohn's disease, or Ulcerative colitis
  • History of stem cell or organ transplant, gut resection surgery (except appendicectomy and cholecystectomy)
  • Bleeding disorder, anaphylaxis, or other major conditions affecting study outcomes
  • Current diagnosis of irritable bowel syndrome (IBS) per Rome IV criteria
  • Use of prebiotics, probiotics, antibiotics, or medications affecting blood pressure, appetite, gut motility, glucose, or lipid levels within 4 weeks before enrollment
  • Use of dietary supplements except vitamin D or calcium within 4 weeks before enrollment
  • Allergy or intolerance to study food ingredients
  • Unwilling or unable to consume study foods or follow protocol (e.g., alcohol limits, animal products)
  • Pregnant or lactating
  • Unwilling to consume non-halal or non-kosher products
  • Estimated energy needs below 1,500 kcal/day or above 3,000 kcal/day
  • Unexplained or unintentional weight loss in past six months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

King's College London

London, United Kingdom, SE1 9NH

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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