Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
King's College London
London, United Kingdom, SE1 9NH
Actively Recruiting
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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