Food Consumption and AppetiteNCT04514588
Associations Between Genetic Markers of Caffeine Metabolism, Appetite Hormones and Body Weight
A study testing caffeine consumption in people with Food Consumption and Appetite and Food Habits, run by Gkouskou Kalliopi at 1 site in Greece.
Trial summary
The effect of caffeine on appetite and body weight is controversial. Mostly epidemiological studies exist that show either a negative effect (reduction of appetite and body weight) or no effect. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Consumption and Appetite, Food Habits, Caffeine
- What is being tested?
- caffeine consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- 30 Jun 2020to 30 Jun 2022
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal weight (BMI<25)
- apparently healthy participants
Who cannot join
- smokers,
- special population groups, i.e. athletes, pregnant women etc.,
- people with a chronic or acute disease and
- those on medication
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University of West Attica
Aigáleo, Attica
Dimitrios Haniotis, prof, dchaniotis@uniwa.gr
About this study
The effect of caffeine on appetite and body weight is controversial. Mostly epidemiological studies exist that show either a negative effect (reduction of appetite and body weight) or no effect. In this trial we are going to study the results of the consumption of 5mgr/kgr body weight of caffeine on appetite, food consumption and hormones ghrelin, asprosin, leptin and pancreatic polypeptide in relation to gene polymorphisms that affect caffeine metabolism and body weight. Seventy subjects will participate in a cross sectional study consisting of two trials (with or without the consumption of caffeine) in order to study the aforementioned parameters. Differences of total calories consumption between fast metabolizers of caffeine and the rest of the participants is the primary outcome.
Read the detailed description
In more detail, participants will be recruited through local advertisements in the university campus so that to be of normal weight (BMI<25) and apparently healthy. Smokers, special population groups, i.e. athletes, pregnant women etc., those having a chronic or acute disease and those on medication will be excluded from the study.
Experimental protocol. Each volunteer will take part in 2 trials (with 7days interval between them) in a random order (using a random-number table). Female participants will be on the follicular phase of their menstrual cycle during the experiments to avoid variability in appetite [doi.org/10.1016/j.appet.2018.01.029.]. The week preceding each experimental day, participants will be instructed to abstain from any caffeine. Furthermore, the day preceding each experimental day participants will be instructed to abstain from alcohol source and physical exercise, to get enough sleep (~7 h) and to come to the lab after an overnight fast of 10 h. Furthermore, the days before the experiment, volunteers will be asked to consume similar foods and quantities, keeping more or less constant eating patterns. Participants will arrive at the lab in the morning 9 am after an overnight fast of 10 h. They will consume a breakfast snack along with one of the three experimental drinks within 5 min. The snack will consist of 1 slice of white bread, 5 g of butter and 10 g of white sugar, providing 142 kcal (6.5% of energy from proteins, 62.5% from carbohydrates and 31.0% from lipids). The experimental drinks will be either (a) 200 mL of instant coffee providing 5 mg caffeine/kg body weight or (b) 200 mL of water (Control). After a 3-h period, participants will be offered an ad libitum lunch meal from a buffet, consisting of common Greek diet foods (pasta, tomato sauce, beef, salad, cheese, yogurt, fruit and juice). They will be instructed to consume as much food as they desire until they feel satiated, within 30 min. Researchers will record the exact amount of food consumed by weighting the foods that will be chosen and their remnants. In addition, a detailed recording of the foods participants are going to consume later in the evening will be performed from a registered dietician through recall questionnaires.
Molecular and biochemical parameters that are going to be recorded with the utilization of standardized generally accepted protocols are blood pressure, body weight and other anthropometric parameters, blood levels of ghrelin, asprosin, leptin, pancreatic polypeptide, insulin and glucose, and genetic markers that are related to caffeine metabolism (CYP1A2 rs2069514 και CYP1A2 rs762251), as well as to an obesity genetic risk score (32SNPs).
Primary and secondary outcomes Based on genotype data, participants will be categorized as fast, medium and slow metabolizers of caffeine. For sample size calculation differences of total calories consumptions between groups will be utilized as primary outcome. More specifically, since a small participation of slow metabolizers are expected, these subjects will be grouped together with medium metabolizers. A difference of total calories consumption that exceeds 20% between the two groups is considered clinically significant. Taking into account an attrition rate of 10% between the two trials (caffeine and control) a total of about 70 participants are required for the study.
Macronutrients (protein, carbohydrates and lipids) consumption, responses on visual analog scales for satiety and appetite, hormones concentrations will be studied as secondary outcomes
- Conditions
- Food Consumption and Appetite, Food Habits, Caffeine
- Being tested
- caffeine consumption
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeine consumptionDietary supplement
In this trial we are going to study the results of the consumption of 5mgr/kgr body weight of caffeine on appetite, food consumption and hormones ghrelin, asprosin, leptin and pancreatic polypeptide in relation to gene polymorphisms that affect caffeine metabolism and body weight
| Study group | Role | What they receive |
|---|---|---|
| caffeine consumption and metabolism | Other | Participants will take part in two trials. Each trial will last one day at least one week apart. During the first trial half of the participants will consume caffeine (5mgr/kgr) and the rest only water. During the second trial a crossover design will be applied Receives: Dietary Supplement: caffeine consumption |
| control | Other | Control group will consume only water (not coffee) and the same parameters will be recorded as previously Receives: Dietary Supplement: caffeine consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
total calories consumption change
a detail recording of foods and their quantities during the day of the trial will take place
Measured: two trials (caffeine and control) two weeks apart each lasting one day
Secondary outcomes (4)
hormones concentrations change
insulin, ghrelin, asprosin, leptin and pancreatic polypeptide
Measured: two trials (caffeine and control) two weeks apart each lasting one day
VAS (visual analog scale-11-likert scale with greater numbers indicating greater appetite) change for appetite
visual analog scales administered in specific time frames 15 min before and 15, 30, 60, 90, 120, 150, 180 min after the consumption of breakfast with or without caffeine
Measured: two trials (caffeine and control) two weeks apart each lasting one day
VAS (visual analog scale 11-likert scale with greater numbers indicating greater satiety) change for satiety
visual analog scales administered in specific time frames 15 min before and 15, 30, 60, 90, 120, 150, 180 min after the consumption of breakfast with or without caffeine
Measured: two trials (caffeine and control) two weeks apart each lasting one day
various macronutrients consumption change
a detail recording of foods and their quantities during the day of the trial will take plac
Measured: two trials (caffeine and control) two weeks apart each lasting one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start30 Jun 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food Consumption and AppetiteStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gkouskou Kalliopi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gkouskou Kalliopi, National and Kapodistrian University of Athens
- Investigators
- Aristides Eliopoulos, prof, Study chair, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514588
- Sponsor's protocol ID
- AP336.30.06.2020
- Status last verified
- Aug 2020
- First submitted
- 2 Aug 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gkouskou KG, Georgiopoulos G, Vlastos I, Lazou E, Chaniotis D, Papaioannou TG, Mantzoros CS, Sanoudou D, Eliopoulos AG. CYP1A2 polymorphisms modify the association of habitual coffee consumption with appetite, macronutrient intake, and body mass index: results from an observational cohort and a cross-over randomized study. Int J Obes (Lond). 2022 Jan;46(1):162-168. doi: 10.1038/s41366-021-00972-6. Epub 2021 Sep 25.
PubMed 34564706
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Genetic Markers of Caffeine Metabolism, Appetite Hormones and Body Weight
- ClinicalTrials.gov ID
- NCT04514588
- Acronym / sponsor ID
- AP336.30.06.2020
- Conditions
- Food Consumption and Appetite, Food Habits, Caffeine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Gkouskou KalliopiUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 17 Aug 2020 (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 effect of caffeine on appetite and body weight is controversial. Mostly epidemiological studies exist that show either a negative effect (reduction of appetite and body weight) or no effect. In this trial we are going to study the results of the consumption of 5mgr/kgr body weight of caffeine on appetite, food consumption and hormones ghrelin, asprosin, leptin and pancreatic polypeptide in relation to gene polymorphisms that affect caffeine metabolism and body weight. Seventy subjects will participate in a cross sectional study consisting of two trials (with or without the consumption of caffeine) in order to study the aforementioned parameters. Differences of total calories consumption between fast metabolizers of caffeine and the rest of the participants is the primary outcome.
Detailed description
In more detail, participants will be recruited through local advertisements in the university campus so that to be of normal weight (BMI<25) and apparently healthy. Smokers, special population groups, i.e. athletes, pregnant women etc., those having a chronic or acute disease and those on medication will be excluded from the study.
Experimental protocol. Each volunteer will take part in 2 trials (with 7days interval between them) in a random order (using a random-number table). Female participants will be on the follicular phase of their menstrual cycle during the experiments to avoid variability in appetite [doi.org/10.1016/j.appet.2018.01.029.]. The week preceding each experimental day, participants will be instructed to abstain from any caffeine. Furthermore, the day preceding each experimental day participants will be instructed to abstain from alcohol source and physical exercise, to get enough sleep (~7 h) and to come to the lab after an overnight fast of 10 h. Furthermore, the days before the experiment, volunteers will be asked to consume similar foods and quantities, keeping more or less constant eating patterns. Participants will arrive at the lab in the morning 9 am after an overnight fast of 10 h. They will consume a breakfast snack along with one of the three experimental drinks within 5 min. The snack will consist of 1 slice of white bread, 5 g of butter and 10 g of white sugar, providing 142 kcal (6.5% of energy from proteins, 62.5% from carbohydrates and 31.0% from lipids). The experimental drinks will be either (a) 200 mL of instant coffee providing 5 mg caffeine/kg body weight or (b) 200 mL of water (Control). After a 3-h period, participants will be offered an ad libitum lunch meal from a buffet, consisting of common Greek diet foods (pasta, tomato sauce, beef, salad, cheese, yogurt, fruit and juice). They will be instructed to consume as much food as they desire until they feel satiated, within 30 min. Researchers will record the exact amount of food consumed by weighting the foods that will be chosen and their remnants. In addition, a detailed recording of the foods participants are going to consume later in the evening will be performed from a registered dietician through recall questionnaires.
Molecular and biochemical parameters that are going to be recorded with the utilization of standardized generally accepted protocols are blood pressure, body weight and other anthropometric parameters, blood levels of ghrelin, asprosin, leptin, pancreatic polypeptide, insulin and glucose, and genetic markers that are related to caffeine metabolism (CYP1A2 rs2069514 και CYP1A2 rs762251), as well as to an obesity genetic risk score (32SNPs).
Primary and secondary outcomes Based on genotype data, participants will be categorized as fast, medium and slow metabolizers of caffeine. For sample size calculation differences of total calories consumptions between groups will be utilized as primary outcome. More specifically, since a small participation of slow metabolizers are expected, these subjects will be grouped together with medium metabolizers. A difference of total calories consumption that exceeds 20% between the two groups is considered clinically significant. Taking into account an attrition rate of 10% between the two trials (caffeine and control) a total of about 70 participants are required for the study.
Macronutrients (protein, carbohydrates and lipids) consumption, responses on visual analog scales for satiety and appetite, hormones concentrations will be studied as secondary outcomes
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| caffeine consumption and metabolism | Other | Dietary Supplement: caffeine consumptionParticipants will take part in two trials. Each trial will last one day at least one week apart. During the first trial half of the participants will consume caffeine (5mgr/kgr) and the rest only water. During the second trial a crossover design will be applied |
| control | Other | Dietary Supplement: caffeine consumptionControl group will consume only water (not coffee) and the same parameters will be recorded as previously |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- normal weight (BMI<25)
- apparently healthy participants
Key exclusion criteria (4 listed)
- smokers,
- special population groups, i.e. athletes, pregnant women etc.,
- people with a chronic or acute disease and
- those on medication
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 |
|---|---|---|
| caffeine consumptionIn this trial we are going to study the results of the consumption of 5mgr/kgr body weight of caffeine on appetite, food consumption and hormones ghrelin, asprosin, leptin and pancreatic polypeptide in relation to gene polymorphisms that affect caffeine metabolism and body weight | Dietary supplement | caffeine consumption and metabolism, control |
Primary outcome
total calories consumption change
Time frame: two trials (caffeine and control) two weeks apart each lasting one day
a detail recording of foods and their quantities during the day of the trial will take place
4 secondary outcomes
hormones concentrations change
Time frame: two trials (caffeine and control) two weeks apart each lasting one day
VAS (visual analog scale-11-likert scale with greater numbers indicating greater appetite) change for appetite
Time frame: two trials (caffeine and control) two weeks apart each lasting one day
VAS (visual analog scale 11-likert scale with greater numbers indicating greater satiety) change for satiety
Time frame: two trials (caffeine and control) two weeks apart each lasting one day
various macronutrients consumption change
Time frame: two trials (caffeine and control) two weeks apart each lasting one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Derived from this study: PubMed 34564706Gkouskou KG, Georgiopoulos G, Vlastos I, Lazou E, Chaniotis D, Papaioannou TG, Mantzoros CS, Sanoudou D, Eliopoulos AG. CYP1A2 polymorphisms modify the association of habitual coffee consumption with appetite, macronutrient intake, and body mass index: results from an observational cohort and a cross-over randomized study. Int J Obes (Lond). 2022 Jan;46(1):162-168. doi: 10.1038/s41366-021-00972-6. Epub 2021 Sep 25.
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.
Aristides Eliopoulos, prof study chair
University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caffeine consumption in people with Food Consumption and Appetite and Food Habits, run by Gkouskou Kalliopi at 1 site in Greece.
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 2 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: status not confirmed, as of the sponsor's last update on 17 Aug 2020. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kalliopi Gkouskou, PhD (+30693855379, gkouskoukal@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total calories consumption change (time frame: two trials (caffeine and control) two weeks apart each lasting one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04514588, which also lists 1 linked publication.
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 17 Aug 2020.