Healthy WomenONTIME-MICNCT03147703
Timing of Food Intake Impacts Daily Rhythms of Human Saliva Microbiota
A study testing Food Timing in people with Healthy Women, run by Universidad de Murcia at 1 site in Spain.
Trial summary
The purpose of this investigation is to test the hypothesis that in humans, eating late may induce changes in saliva microbiota daily rhythms towards a more obesogenic and a less responsiveness to dietary treatments profile. Read more about this study
- Who is it for?
- Ages 20 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women
- What is being tested?
- Food Timing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2015to 31 Jul 2015
- 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 20 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women
- Body Mass Index: 20 to 30 kg/m2
- Caucasian
- Day workers
Who cannot join
- Endocrine (Diabetes mellitus or others), renal, hepatic, cancer or psychiatric disorders
- Receiving any pharmacologic treatment other than oral contraceptives
- Bulimia diagnosis, prone to binge eating
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timing of Food Intake Impacts Daily Rhythms of Human Saliva Microbiota in a Mediterranean Population
The purpose of this investigation is to test the hypothesis that in humans, eating late may induce changes in saliva microbiota daily rhythms towards a more obesogenic and a less responsiveness to dietary treatments profile. These changes in microbiota may partly explain the weight loss difficulties that characterized late eaters in previous studies. Thus, the aim is to analyze the effect of the timing of food intake in humans' saliva microbiome daily rhythms in a randomized, crossover interventional study, in order to achieve.
Read the detailed description
Overweight and obesity can currently be considered a major threat to human health. Recent studies suggest that not only "what" we eat, but also "when" we eat may have a significant role in obesity treatment. The importance of caloric distribution across the day on weight loss therapy was supported by a 12-weeks experimental study showing that subjects assigned to high caloric intake during breakfast lost significantly more weight than those assigned to high caloric intake during the dinner. These results suggest that eating late may affect obesity and impair the success of weight loss therapies.
Novel evidence from animal and human studies indicates that the composition of the gut microbiota may also be involved in obesity and weight loss. Moreover, studies performed in extreme obese subjects have demonstrated that weight loss improves the obesity-associated gut microbiota composition towards a lean microbiome phenotype.
A recent study has shown that the timing of food intake influences microbiota in mice model. This study reported that obesity dampens the cyclical changes in the gut microbiome of mice while time-restricted feeding (TRF), in which feeding is consolidated to the nocturnal phase, partially restores these cyclical fluctuations. Furthermore, TRF which protects against obesity and metabolic diseases affects bacteria and has shown to influence host metabolism. Then, feeding pattern and time of food intake, in addition to diet, are important parameters when assessing the microbiome's contribution to mice metabolism. However, to our knowledge no human studies are available showing the effect of timing of food intake in microbiota.
Thus, the aim was to analyze the effect of the timing of food intake in humans' saliva microbiome, in order to achieve a better understanding of the relationship between food timing, obesity and weight loss in humans.
This goal will be achieved through a specific approach:
- Interventional (randomized, cross-over controlled trials) (Aim 1): To study that, eating late may induce changes in saliva microbiota daily rhythms towards a more obesogenic pattern and a less responsiveness to dietary treatments profile in women (n=10).
- Conditions
- Healthy Women
- Being tested
- Food Timing
- Keywords
- Microbiota, Food timing, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food TimingBehavioural
the timing of the main meal of the day (lunch in Spain) is changed from early (14:00) to late (17:30) and viceversa in a randomized and crossover way
| Study group | Role | What they receive |
|---|---|---|
| Early Eating (EE) | Experimental | The intervention is Food Timing, Early Eating is defined at 13:00 hours for lunch Receives: Behavioral: Food Timing |
| Late Eating (LE) | Experimental | The intervention is Food Timing, Late Eating is defined for 17:30 hours for lunch Receives: Behavioral: Food Timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva microbiome daily rhythms
Investigators will measure daily rhythms of saliva microbiome at early eating and late eating visits.
Measured: Total of 4 weeks. Samples will be collected after week 1 and 2 and at week 4.
Feces microbiome daily rhythms
Investigators will assess gut microbiome with one feces sample at early eating and late eating visits.
Measured: Total of 4 weeks. Samples will be collected after week 1 and 2 and at week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Jun 2015
- Primary completion1 Jul 2015
- Study completion31 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy WomenStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PROF. MARTA GARAULET AZA, Universidad de Murcia
- Investigators
- Marta Garaulet, PHD, Study director, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147703
- Sponsor's protocol ID
- 2017ES00003
- Acronym
- ONTIME-MIC
- Status last verified
- Apr 2021
- First submitted
- 25 Apr 2017
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Spain: Ministry of Health and consumption
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Food Intake Impacts Daily Rhythms of Human Saliva Microbiota in a Mediterranean Population
- ClinicalTrials.gov ID
- NCT03147703
- Acronym / sponsor ID
- ONTIME-MIC / 2017ES00003
- Conditions
- Healthy Women
- Keywords
- Microbiota, Food timing, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 31 Jul 2015 (actual)
- First posted
- 10 May 2017 (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 purpose of this investigation is to test the hypothesis that in humans, eating late may induce changes in saliva microbiota daily rhythms towards a more obesogenic and a less responsiveness to dietary treatments profile. These changes in microbiota may partly explain the weight loss difficulties that characterized late eaters in previous studies. Thus, the aim is to analyze the effect of the timing of food intake in humans' saliva microbiome daily rhythms in a randomized, crossover interventional study, in order to achieve.
Detailed description
Overweight and obesity can currently be considered a major threat to human health. Recent studies suggest that not only "what" we eat, but also "when" we eat may have a significant role in obesity treatment. The importance of caloric distribution across the day on weight loss therapy was supported by a 12-weeks experimental study showing that subjects assigned to high caloric intake during breakfast lost significantly more weight than those assigned to high caloric intake during the dinner. These results suggest that eating late may affect obesity and impair the success of weight loss therapies.
Novel evidence from animal and human studies indicates that the composition of the gut microbiota may also be involved in obesity and weight loss. Moreover, studies performed in extreme obese subjects have demonstrated that weight loss improves the obesity-associated gut microbiota composition towards a lean microbiome phenotype.
A recent study has shown that the timing of food intake influences microbiota in mice model. This study reported that obesity dampens the cyclical changes in the gut microbiome of mice while time-restricted feeding (TRF), in which feeding is consolidated to the nocturnal phase, partially restores these cyclical fluctuations. Furthermore, TRF which protects against obesity and metabolic diseases affects bacteria and has shown to influence host metabolism. Then, feeding pattern and time of food intake, in addition to diet, are important parameters when assessing the microbiome's contribution to mice metabolism. However, to our knowledge no human studies are available showing the effect of timing of food intake in microbiota.
Thus, the aim was to analyze the effect of the timing of food intake in humans' saliva microbiome, in order to achieve a better understanding of the relationship between food timing, obesity and weight loss in humans.
This goal will be achieved through a specific approach:
- Interventional (randomized, cross-over controlled trials) (Aim 1): To study that, eating late may induce changes in saliva microbiota daily rhythms towards a more obesogenic pattern and a less responsiveness to dietary treatments profile in women (n=10).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Eating (EE) | Experimental | Behavioral: Food TimingThe intervention is Food Timing, Early Eating is defined at 13:00 hours for lunch |
| Late Eating (LE) | Experimental | Behavioral: Food TimingThe intervention is Food Timing, Late Eating is defined for 17:30 hours for lunch |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy women
- Body Mass Index: 20 to 30 kg/m2
- Caucasian
- Day workers
Key exclusion criteria (4 listed)
- Endocrine (Diabetes mellitus or others), renal, hepatic, cancer or psychiatric disorders
- Receiving any pharmacologic treatment other than oral contraceptives
- Bulimia diagnosis, prone to binge eating
- Pregnancy
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 |
|---|---|---|
| Food Timingthe timing of the main meal of the day (lunch in Spain) is changed from early (14:00) to late (17:30) and viceversa in a randomized and crossover way | Behavioural | Early Eating (EE), Late Eating (LE) |
Primary outcome
Saliva microbiome daily rhythms
Time frame: Total of 4 weeks. Samples will be collected after week 1 and 2 and at week 4.
Investigators will measure daily rhythms of saliva microbiome at early eating and late eating visits.
Feces microbiome daily rhythms
Time frame: Total of 4 weeks. Samples will be collected after week 1 and 2 and at week 4.
Investigators will assess gut microbiome with one feces sample at early eating and late eating visits.
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 22 Apr 2021.
- Individual participant dataSharing planned: No. Spain: Ministry of Health and consumption
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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.
Marta Garaulet, PHD study director
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Timing in people with Healthy Women, run by Universidad de Murcia at 1 site in Spain.
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 4 inclusion and 4 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 22 Apr 2021. 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 Spain. 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?
Saliva microbiome daily rhythms (time frame: Total of 4 weeks. Samples will be collected after week 1 and 2 and at week 4.). 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 22 Apr 2021.