Feeding BehaviorTIMCNCT03949543
The Timing of Main Meal Consumption Effect on Gut Microbiota and Host
A study testing Large Lunch Intervention and Large Dinner Intervention in people with Feeding Behavior and Gastrointestinal Microbiome, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Feeding Behavior, Gastrointestinal Microbiome, Diet
- What is being tested?
- Large Lunch Intervention and Large Dinner Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Oct 2017to 28 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) Healthy adult people
Who cannot join
- History of gut surgery
- Use of antibiotics or steroids the last 3 months
- Positive or negative energy balance (recent weight gain or loss, ±2 Kg the past month)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Medicine, University of Glasgow / New Lister Building, Glasgow Royal Infirmary
Glasgow, G312ER
About this study
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.
Read the detailed description
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.
- Conditions
- Feeding Behavior, Gastrointestinal Microbiome, Diet, Meal Time
- Being tested
- Large Lunch Intervention, Large Dinner Intervention
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large Lunch InterventionOther
Participants were asked to consume 60% of their daily energy requirements as lunch, between 12:30 and 13:30. Breakfast accounted for 15% of their total daily energy, a morning and evening snack for 5%. 15% was given for light meal either as dinner.
Large Dinner InterventionOther
Participants were asked to consume 60% of their daily energy requirements as dinner, between 19:30 and 20:30, each day during their two dietary interventions. Breakfast accounted for 15% of their total daily energy, a morning and evening snack for 5%. 15% was given for light meal either as lunch.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adult Participants A | Experimental | Participants who will get two interventional diets, for 7 days each, but allocated to start with large lunch intervention Receives: Other: Large Lunch Intervention; Other: Large Dinner Intervention |
| Healthy Adult Participants B | Experimental | Participants who will get two interventional diets, for 7 days each, but allocated to start with large dinner intervention Receives: Other: Large Lunch Intervention; Other: Large Dinner Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome alpha diversity
Shannon diversity index
Measured: 7 days post-intervention
Faecal short chain fatty acids
Short chain fatty acids (umol/g)
Measured: 7 days post-intervention
Secondary outcomes (7)
HDL
mmol/L
Measured: 7 days post-intervention
LDL
mmol/L
Measured: 7 days post-intervention
Triglycerides
mmol/L
Measured: 7 days post-intervention
Glucose
mmol/L
Measured: 7 days post-intervention
Insulin
mU/L
Measured: 7 days post-intervention
IL-6
pg/mL
Measured: 7 days post-intervention
tnf alpha
pg/mL
Measured: 7 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start10 Oct 2017
- Primary completion28 May 2018
- Study completion28 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Konstantinos Gerasimidis, University of Glasgow
- Investigators
- Konstantinos Gerasimidis, BSc MSc PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949543
- Sponsor's protocol ID
- 200170046
- Acronym
- TIMC
- Status last verified
- May 2019
- First submitted
- 9 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Meal Timing as an Acute Modifier of the Gut Microbiota and the Cardiometabolic Health of the Host.
- ClinicalTrials.gov ID
- NCT03949543
- Acronym / sponsor ID
- TIMC / 200170046
- Conditions
- Feeding Behavior, Gastrointestinal Microbiome, Diet, Meal Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 28 May 2018 (actual)
- Study completion
- 28 May 2018 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult Participants A | Experimental | Other: Large Lunch Intervention, Other: Large Dinner InterventionParticipants who will get two interventional diets, for 7 days each, but allocated to start with large lunch intervention |
| Healthy Adult Participants B | Experimental | Other: Large Lunch Intervention, Other: Large Dinner InterventionParticipants who will get two interventional diets, for 7 days each, but allocated to start with large dinner intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Healthy adult people
Key exclusion criteria (3 listed)
- History of gut surgery
- Use of antibiotics or steroids the last 3 months
- Positive or negative energy balance (recent weight gain or loss, ±2 Kg the past month)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Large Lunch InterventionParticipants were asked to consume 60% of their daily energy requirements as lunch, between 12:30 and 13:30. Breakfast accounted for 15% of their total daily energy, a morning and evening snack for 5%. 15% was given for light meal either as dinner. | Other | Healthy Adult Participants A, Healthy Adult Participants B |
| Large Dinner InterventionParticipants were asked to consume 60% of their daily energy requirements as dinner, between 19:30 and 20:30, each day during their two dietary interventions. Breakfast accounted for 15% of their total daily energy, a morning and evening snack for 5%. 15% was given for light meal either as lunch. | Other | Healthy Adult Participants A, Healthy Adult Participants B |
Primary outcome
Gut microbiome alpha diversity
Time frame: 7 days post-intervention
Shannon diversity index
Faecal short chain fatty acids
Time frame: 7 days post-intervention
Short chain fatty acids (umol/g)
7 secondary outcomes
HDL
Time frame: 7 days post-intervention
LDL
Time frame: 7 days post-intervention
Triglycerides
Time frame: 7 days post-intervention
Glucose
Time frame: 7 days post-intervention
Insulin
Time frame: 7 days post-intervention
IL-6
Time frame: 7 days post-intervention
tnf alpha
Time frame: 7 days post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos Gerasimidis, BSc MSc PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Large Lunch Intervention and Large Dinner Intervention in people with Feeding Behavior and Gastrointestinal Microbiome, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome alpha diversity (time frame: 7 days post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.