Effects of Plant Foods on Gastrointestinal and Cardiometabolic Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorKing's College London
About this trial
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
Eligibility criteria
Qualifiers
Adults aged 30-70 years of age
Capacity to give informed consent in English
Consume equal or less than the average UK plant food intake (number and quantity)
Consume less than 30 g/d of fibre
Disqualifiers
Medical history of any of the following: diabetes, major active or historic psychiatric conditions (e.g., schizophrenia), current eating disorder, alcohol abuse, active treatment for cancer in the last year, severe neurological, endocrine, renal, cardiac or pulmonary disease (or any other chronic medical condition), severe oesophagitis, gastritis or duodenitis, active diverticulitis or intestinal/colonic strictures, Coeliac disease, Crohn's disease or Ulcerative colitis, stem cell or organ transplant, gut resection surgery (excluding appendicectomy and cholecystectomy), bleeding disorder, anaphylaxis or any other major or chronic condition known to impact study outcome measures.
A current diagnosis of IBS, as defined by the Rome IV criteria.
Prebiotics and probiotics 4 weeks prior to enrolment.
Antibiotics within 4 weeks of enrolment.
Trial design
Treatments tested in this trial
- A diet containing plant foods
- A diet containing different plant foods
Treatment groups
248 Participants
are divided into 2 treatment groupsSponsors and collaborators
King's College London
Lead sponsor
Biotechnology and Biological Sciences Research Council
Collaborator
University of Southampton
Collaborator
University of Leeds
Collaborator
Source ClinicalTrials.gov