Feeding Behavior Clinical Trial
Official title:
A Randomised Controlled Trial of Meal Timing as an Acute Modifier of the Gut Microbiota and the Cardiometabolic Health of the Host.
The interplay between diet and the gut microbiota has been implicated in the onset of
cardiovascular disease. The gut microbiota displays diurnal rhythms, which may be influenced
by meal timing. This study aimed to investigate the effect of main meal consumption timing on
the microbiota and the cardiometabolic factors of the host using a cross-over RCT in healthy
adults
The main outcome measurements will be: a) changes in gut microbiota composition based on 16S
rRNA gene amplicon sequencing and shotgun metagenomics, b) changes in bacterial functional
capacity) and urinary/faecal metabolomics, c) changes in targeted bacterial metabolites,
d)Inflammatory markers
The aim of this study is to explore the effect of the timing of main meal consumption on gut
microbiota and immune response in healthy adults.
This study will be an open-label, cross-over RCT in healthy adults. Healthy adult (>18 y)
participants will be recruited from the community by means of an advertisement leaflet (see
associated supporting document-"Advertisement flyer") and word of mouth. The researcher will
arrange a meeting with those expressing an interest about the study. The researcher will
collect demographic information (e.g. age and gender) and ask the subjects whether they
suffer from any acute or chronic illness (defined as illness which requires regular visits to
health services) (see associated supporting document-"Health Questionnaire"). If they suffer
from a chronic illness they will be excluded. Other exclusion criteria include history of
previous of major gut surgery, unstable weight, use of antibiotics or steroids the last 3
months. Participants will be informed about the study at Human Nutrition, New Lister
Building, Glasgow Royal Infirmary, or at the University of Glasgow main campus social areas
(e.g. Gilchrist). No children will be recruited. Subjects who have expressed an interest
about the study but are not suitable to participate will be acknowledged and will receive an
explanation as to why they have been excluded.
Following informed written consent, participants will be randomly allocated to intervention
groups using the MS Excel "rand()" function. Women will start their intervention on the same
phase of their menstrual cycle to avoid the effect of hormonal changes on study outcome.
Dietary interventions: Participants will be asked to undertake two experimental diets. The
two dietary interventions are identical with the only difference being the timing of the main
meal consumption (dinner and lunch). Participants will follow each diet for a period of one
week with a three week washout period between the two interventions. The wash out period aims
to drive the gut microbiota characteristics back to baseline levels. The diet will provide
the average energy requirements of the participants (Department of Health) and aims to keep
participants' weight stable during the study period. All dietary aspects of the study will be
designed and supervised by the qualified dietitians/nutritionists, who are members of the
research team. Participants will be given a list of meals and snacks to choose from (see
associated supporting document-"Food List Preferences"). All meals will be provided to the
participants free of charge. Meals will be ordered online by the researchers, using the
University of Glasgow Hub, and will be delivered to the participants' residence by the
supermarket staff. Weight and height will be measured.
Week 1 Participants will follow a structured diet containing meals of their choice for a
week. The participants will select these meals from a list which the researcher will provide
to them. The timing of the meal will be specified and the participants will have to complete
their meals within 25±5 minutes. The participants will be given written instructions on how
to follow the diet (see associated supporting document-"Instruction Sheet" & "Participant
Study Calendar"). Participants will provide all faecal samples produced during days from noon
of day 5 to noon of day 8. Fasted blood (6 ml) and urine samples will be collected the day
after the end of the Week 1 intervention (i.e. day 8). These will be collected at the Human
Nutrition laboratory, at the New Lister Building, Glasgow Royal Infirmary. Weight and height
measurements will be repeated.
Week 2, 3 & 4 During the wash out period, the participants will follow their habitual diet
and no research intervention will take place.
Week 5 This will be replication of the dietary intervention and sample collection at Week 1.
The only difference is that lunch meal from Week 1 will swap to dinners in Week 5.
Diet compliance: Over the course of the two experimental diets compliance will be monitored
by asking participants to complete a "checklist" with their prescribed diet (see associated
supporting document-"Compliance Questionnaire"). A gentle reminder call or text will be sent
to the participants every 3 days to increase participants' motivation and compliance on the
diets.
Sample collection & analysis: Fresh faecal and urine samples will be collected as described
above. The main outcome measurements will be: a) changes in gut microbiota composition based
on 16S rRNA gene amplicon sequencing and shotgun metagenomics, b) changes in bacterial
functional capacity (whole genome shotgun metagenomics) and urinary/faecal metabolomics, c)
changes in targeted bacterial metabolites (short chain fatty acids, sulphide, ammonia,
lactate, succinate, ethanol). Blood lipids, appetite hormones, adipokines, and inflammatory
markers will be measured using ELISA kits. Stool samples will be collected from participants'
homes or delivered to the lab by pre-paid taxi.
Detailed analysis: Genomic DNA will be extracted by the faecal samples using in-house
developed assays. The sample will be tested for purity on 1% Agarose gel and the
concentration of nucleic acids will be measured with Nanodrop. Amplification of the V4 region
of the 16S rRNA gene will be performed in house using PCR and High Fidelity Mastermix and
Golay Barcodes. The pooled sample will be sent to the University of Birmingham for 250 bp
pair-end sequencing on MiSeq. The data will be analysed by Dr Gerasimidis PDRA in
Bioinfomatics. Similarly measurements of SCFA will be performed in acidified ether extracts
using Gas Chromatography equipped with an FID detector. Quantification will be performed
against authentic standards. Other bacterial metabolites and cardiovascular markers will be
assayed with colorometric and enzymatic assays and commercially available ELISA kits as these
have been reported previously. https://www.ncbi.nlm.nih.gov/pubmed/28318688 and
https://www.ncbi.nlm.nih.gov/pubmed/26119811
Power calculation: An accurate power calculation is impossible to compute due to lack of
pilot data. Based on a similar study for a mean difference of 5.4 μmol/g of faecal acetate
(SD=5) and 80% power, 20 participants are required. Power calculation will be revised
following recruitment and study completion of the first 7 participants.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04502979 -
Learning to Love Mealtime Together
|
N/A | |
Completed |
NCT03334266 -
Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months
|
N/A | |
Completed |
NCT03651258 -
Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play
|
||
Completed |
NCT05992753 -
Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels
|
||
Completed |
NCT03332108 -
Novel Approach To Improving Lactation Support With Mobile Health Technology
|
N/A | |
Completed |
NCT03941392 -
Nutritional Study in Spanish Pediatric Population
|
||
Not yet recruiting |
NCT05059574 -
Breast Crawling,Breastfeeding Success and Mothers' Attitudes to Feeding Their Babies
|
N/A | |
Completed |
NCT03242863 -
Effect of Varying Proportions of Low and High Energy Dense Foods Over 5 Days in Preschool Children
|
N/A | |
Completed |
NCT03127579 -
Family Meal Duration and Children's Eating Behavior
|
N/A | |
Completed |
NCT02996422 -
Appalachians Together Restoring the Eating Environment: Improving Healthy Diet in Rural Appalachian Kentucky
|
N/A | |
Enrolling by invitation |
NCT03755999 -
A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period
|
N/A | |
Recruiting |
NCT03439618 -
Comparison of Time-restricted Feeding and Continuous Feeding in Critically Ill Patients
|
N/A | |
Completed |
NCT03488680 -
Effectiveness of Behavior Change Communication in Improving Feeding Practices, Nutritional and Health Status of Infants
|
N/A | |
Recruiting |
NCT04960969 -
The Effects of Time-Restricted Eating Model
|
N/A | |
Completed |
NCT02930642 -
Food Insecurity, Obesity, and Impulsive Food Choice
|
N/A | |
Completed |
NCT03926065 -
Variations in Palatability and Portion Size of Vegetables on Meal Intake of Preschool Children
|
N/A | |
Completed |
NCT03886428 -
The Influence of Satiation Measures on the Portion Size Effect
|
N/A | |
Completed |
NCT03025815 -
Effects of the Oral Stimulation Program in Extreme Preterm Infants
|
N/A | |
Completed |
NCT02347527 -
Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals
|
N/A | |
Completed |
NCT03664154 -
Stress and Feeding (SAFE): A Pilot Intervention for Mothers and Their Preterm Infants
|
N/A |