King's College London
London, SE1 9NH, United Kingdom
Location status: Recruiting
NCT Number: NCT07586111
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
Interested in participating?
Request Info30 year–70 year
All sexes
Interventional
Not applicable
London, SE1 9NH, United Kingdom
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Study meals, snacks and drinks will be provided that contain plant foods for four weeks (6 days a week). Participants will follow guidance in self-selecting foods on one day per week.
Other names: Study Diet A
Study meals, snacks and drinks will be provided that contain plant foods for four weeks (6 days a week). Participants will follow guidance in self-selecting foods on one day per week.
Other names: Study Diet B
Time frame: Week 4
The diversity of microbial taxa in faecal samples at 4 weeks assessed by calculating alpha-diversity score from 16S ribosomal RNA sequencing.
Time frame: Baseline, Week 4
Absolute and change in alpha-diversity as measured by the diversity of micriobial taxa in faecal samples via 16S RNA sequencing.
Time frame: Baseline, Week 4
The diversity of microbial taxa in faecal samples by calculating beta-diversity via 16S ribosomal RNA sequencing.
Time frame: Baseline, Week 4
Absolute and change in microbiota composition of faecal samples between baseline and Week 4 as assessed by 16S ribosomal RNA sequencing.
Time frame: Baseline, Week 4
Absolute and change in short-chain fatty acids through Liquid Chromatography - Mass Spectrometry using validated assays.
Time frame: Baseline, Week 4
Absolute and change in bile acids through Liquid Chromatography - Mass Spectrometry using validated assays.
Time frame: Baseline, Week 4
Metabolomics analysis via 1H NMR spectroscopy.
Time frame: Baseline, Week 4
Absolute and change in water content of faecal samples assessed via oven drying.
Time frame: Baseline, Week 4
Absolute and change in stool frequency measured via prospective 7-day stool diary
Time frame: Baseline, Week 4
Absolute and change in stool consistency measured by Bristol stool form scale. Scale from 1 to 7.
Time frame: Baseline, Week 4
Absolute and change in gastrointestincal symptons measured by Gastrointestinal symptoms rating scale score. Scored from 15 to 105 with lower scores indicating less severe symptoms.
Time frame: Baseline, Week 4
Flow mediated dilation measured via ultrasound of arm.
Time frame: Baseline, Week 4
Metabolomics measured via 1H NMR spectroscopy.
Time frame: Baseline, Week 4
Metabolomics via Liquid Chromatography-Mass Spectroscopy using validated assays.
Time frame: Baseline, Week 4
Absolute and change in diastolic and systolic blood pressure.
Time frame: Baseline, Week 4
Absolute and change in body composition measured via biolelectrical impedance analysis (BIA).
Time frame: Baseline, Week 4
Absolute and change in waist circumference assessed by tape measure.
Time frame: Baseline, Week 4
Dietary intake measured by aggregating EPIC Norfolk food frequency questionnaire, daily food and drink diaries and food checklists.
Time frame: Baseline, Week 4
Absolute and change in biomarkers of dietary intake as measured via validated assays.
Time frame: Baseline, Week 4
Absolute and change in SF-36 questionnaire scores.
Time frame: Baseline, Week 4
Absolute and change in Patient Health Questionnaire-8 and Anxiety and Depression Scale scores.
Time frame: Baseline, Week 4
Acceptability of diet measured through a diet acceptability questionnaire containing multiple choice and open-ended questions.
Time frame: Week 4
Absolute diet satisfaction measured by Food benefits assessment scale. Scored from 41 to 205 with a lower score indicating a higher diet satisfaction.
Time frame: Baseline, Week 4
Adherence to the intervention as measured by consumption of study meals, snacks and drinks.
King's College London
Other
A Randomised Controlled Trial Investigating the Impact of Plant Foods on Gastrointestinal and Cardiometabolic Health
Acronym: PLANTIFUL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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