ObesityNCT05774119
Effect of Coffee Consumption on Appetite Traits in Overweight and Obesity
A study testing breakfast with coffee and breakfast with water in people with Obesity, run by University of Guadalajara at 1 site in Mexico.
Trial summary
The effect of coffee consumption on appetite is not clear, there are studies that show an effect on the regulation of energy intake, reducing hunger and/or increasing satiety. The purpose of this trial is to evaluate the effect of 6 mg/caffeine/kg of body weight on hunger, satiety, dietary intake, biochemical… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- breakfast with coffee and breakfast with water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- 31 Jan 2022to 1 Sep 2023
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between 20 and 40 years old
- Body mass index between 25-40 kg/m2.
- Regular menstrual cycle of 23-32 days in the last 3 months.
- Moderate consumption of coffee (up to 4 cups per day)
- Having the habit of eating breakfast
- Availability of time in the morning
Who cannot join
- Use of any type of contraceptives in the last three months.
- Use of hypoglycemic, lipid-lowering, weight-loss, appetite altering and psychiatric medications.
- Diagnosis of diabetes mellitus, hypertension, cancer, polycystic ovary syndrome, hypothyroidism, hyperthyroidism, infectious disease, renal disease, dysgeusia, and gallbladder disease.
- Weight loss ≥5% of their weight in the last 6 months.
- Consumption of more than 20 g of alcohol per day.
- Smoking
- Pregnant or breastfeeding
- vegetarian or vegan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Coffee Consumption on Hunger, Satiety, and Appetite-regulating Hormones in Women With Overweight or Obesity
The effect of coffee consumption on appetite is not clear, there are studies that show an effect on the regulation of energy intake, reducing hunger and/or increasing satiety. The purpose of this trial is to evaluate the effect of 6 mg/caffeine/kg of body weight on hunger, satiety, dietary intake, biochemical variables and ghrelin and cholecystokinin concentration in overweight and obese women.
Read the detailed description
Randomized crossover clinical trial to be realized in women between 20 and 40 years of age with overweight or obesity and apparently healthy who reside in the city of Guadalajara, Jalisco.
Their participation involves their attendance to 3 interventions, in the first one it is verified whether or not they meet the inclusion criteria, a clinical history is applied to take information on pathological history, clinical data, nutritional aspects, sociodemographic and lifestyle aspects and anthropometric measurements; then they are randomly assigned to the two types of interventions in the next two subsequent ones.
In the second and third interventions (with an interval of 7 days between them), participants will attend in the follicular phase of their menstrual cycle during the experiments to avoid variability in appetite.
They will arrive at the institute at 8 am after an overnight fast, consume a standard 400 kcal breakfast with a distribution of 55% carbohydrates, 30% lipids and 15% protein. along with 240 ml of coffee with 6 mg/caffeine/kg body weight or the same breakfast, but with 240 ml of water.
On an empty stomach and every 30 min during the 3 h following the consumption of breakfast with the beverage, the participants recorded their level of hunger, fullness, satiety, desire to eat and prospective consumption, desire to eat specific foods: sweet, salty, fatty, tasty, and sed through visual analog scales (VAS).
On an empty stomach, 30 minutes after consuming breakfast with the beverage and after 180 min, a blood sample will be taken from which serum will be obtained for glucose, total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, triglycerides, ghrelin and cholecystokinin determinations.
In the first intervention, participants will be instructed to fill out a 24-hour reminder form to assess dietary intake, and will be asked to record all food and beverages consumed for 3 days prior to the two interventions. Participants will also be instructed to fill out a 24-hour post-breakfast reminder with or without coffee.
- Conditions
- Obesity
- Being tested
- breakfast with coffee, breakfast with water
- Keywords
- coffee, hunger, ghrelin, cholecystokinin
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breakfast with coffeeOther
breakfast with coffee with 6 mg/caffeine/kg body weight
breakfast with waterOther
breakfast with 250 mL of water
| Study group | Role | What they receive |
|---|---|---|
| breakfast with coffee | Experimental | 250 mL of water with 6 mg/caffeine/kg Receives: Other: breakfast with coffee |
| breakfast with water | Placebo comparator | 250 mL of water Receives: Other: breakfast with water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ghrelin concentration
Ghrelin hormone measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is GHRL/Ghrelin ELISA Kit catalog number ELH-GHRL. Ghrelin is measured in pg/mL.
Measured: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
Change in cholecystokinin concentration
Cholecystokinin measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is Human CCK Enzyme Immunoassay Kit catalog number EIA-CCK-1. Cholecystokinin is measured in pg/mL.
Measured: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
Change in dietary intake
Analysis of the 24 hour dietary intake recall consumed the rest of the day after the intervention. Analyzed with the Nutritionist Pro TM Software.
Measured: Post intervention, the following 24 hours after finishing the intervention
Change in appetite feelings
Hunger, fullness, satiety, desire to eat and prospective consumption are assessed with the visual analog scales (VAS). They are composed of 100 mm long lines, where at one end the term "None" or "Not at all" is placed and at the other end the term "Yes, a lot" or "As much as I have never felt". The patient marks a point between these two extremes and quantification is done by measuring the distance from the left end of the line to the mark which is scored.
Measured: Baseline and in the following 180 minutes postprandially, measured every 30 minutes.
Change in desire for specific types of food
The desire to eat specific foods: sweet, salty, fatty, tasty and thirsty, was evaluated with visual analog scales, consisting of lines in which at one end is placed the term "Yes, very much" and at the other end the term "No, not at all". The patient marks a point between these two extremes and quantification is done by measuring the distance from the left end of the line to the mark, to which a score is given.
Measured: Baseline and in the following 180 minutes postprandially, measured every 30 minutes.
Secondary outcomes (4)
Change in plasma glucose
Peripheral blood samples were taken by a venous puncture after 12 h of fasting and at 120 min postprandial, and they were immediately centrifuged at 3500 rpm to obtain serum. The serum was separated and stored at -80 ◦C for later use. The concentration of glucose, was measured with a dry chemistry analyzer "Vitros 350 Chemistry" (Ortho-Clinical Diagnostics, Johnson \& Johnson Services Inc., Rochester, NY, USA).
Measured: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
Change in lipid profile: total cholesterol, triglycerides, high density lipoprotein, low-density lipoprotein, very low-density lipoprotein
Peripheral blood samples were taken by a venous puncture after 12 h of fasting, 30 min and at 180 min postprandial, and they were immediately centrifuged at 3500 rpm to obtain serum. The serum was separated and stored at -80 ◦C for later use. The concentration of triglycerides, total cholesterol, and high-density lipoprotein cholesterol (HDL-c) cholesterol was measured with a dry chemistry analyzer Vitros 350 Chemistry (Ortho-Clinical Diagnostics, Johnson \& Johnson Services Inc., Rochester, NY, USA). Low-density lipoprotein cholesterol (LDL-c) was calculated with the Friedewald formula, except when triglycerides levels were higher than 400 mg/dL. Very-low-density lipoprotein cholesterol (VLDL-c) was calculated as total cholesterol minus the sum of LDL-c + HDL-c.
Measured: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
24 hour dietary intake recall pre-intervention
Analysis of the 24 hour dietary intake recall consumed the day previous to the intervention. Analyzed with the Nutritionist Pro TM Software.
Measured: Baseline
Physical activity
It is evaluated with the International Physical Activity Questionnaire (IPAQ). The questionnaire allows to obtain a quantitative calculation of the MET's (metabolic equivalents), which are a measure that expresses the energetic cost of physical activities. A higher score indicates greater physical activity. The minimum value is 3.3 MET´s /minute/week and there is no a maximum value.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start31 Jan 2022
- Primary completion15 May 2023
- Study completion1 Sep 2023
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 ObesityStudies 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
- Model description
- Crossover randomized clinical trial. Premenopausal women with overweight or with obesity will be included. The participants attend 3 sessions: in the first, a clinical history is applied, and anthropometric measurements are taken; in the second and third sessions they consume a standard breakfast (519 kcal) together with 240 ml of coffee with 6 mg/caffeine/kg of weight or the same breakfast but accompanied by 240 ml of water. The sequence of the type of intervention is randomly assign with a period of 1 week wash. Fasting and every 30 minutes during the 3 hours following breakfast consumption, sensations of appetite are recorded using visual analog scales. Fasting, 30 and 180 min after breakfast consumption, ghrelin and cholecystokinin levels are measured. Dietary intake is recorded on the day before the two interventions and on the day of intervention, after breakfast consumption.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livier Nathaly Torres Castillo, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774119
- Sponsor's protocol ID
- CI-03421
- Status last verified
- Feb 2024
- First submitted
- 1 Nov 2022
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Magana-de la Vega L, Martinez-Lopez E, Sanchez-Murguia T, Madrigal-Juarez A, Rodriguez-Reyes SC, Aguilar-Vega I, Torres-Castillo N. Effect of coffee intake on appetite parameters in woman with overweight or obesity: A pilot crossover randomized trial. Endocrinol Diabetes Nutr (Engl Ed). 2024 Jun-Jul;71(6):236-245. doi: 10.1016/j.endien.2024.03.021.
PubMed 38986627
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coffee Consumption on Hunger, Satiety, and Appetite-regulating Hormones in Women With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT05774119
- Acronym / sponsor ID
- CI-03421
- Conditions
- Obesity
- Keywords
- coffee, hunger, ghrelin, cholecystokinin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 17 Mar 2023 (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 coffee consumption on appetite is not clear, there are studies that show an effect on the regulation of energy intake, reducing hunger and/or increasing satiety. The purpose of this trial is to evaluate the effect of 6 mg/caffeine/kg of body weight on hunger, satiety, dietary intake, biochemical variables and ghrelin and cholecystokinin concentration in overweight and obese women.
Detailed description
Randomized crossover clinical trial to be realized in women between 20 and 40 years of age with overweight or obesity and apparently healthy who reside in the city of Guadalajara, Jalisco.
Their participation involves their attendance to 3 interventions, in the first one it is verified whether or not they meet the inclusion criteria, a clinical history is applied to take information on pathological history, clinical data, nutritional aspects, sociodemographic and lifestyle aspects and anthropometric measurements; then they are randomly assigned to the two types of interventions in the next two subsequent ones.
In the second and third interventions (with an interval of 7 days between them), participants will attend in the follicular phase of their menstrual cycle during the experiments to avoid variability in appetite.
They will arrive at the institute at 8 am after an overnight fast, consume a standard 400 kcal breakfast with a distribution of 55% carbohydrates, 30% lipids and 15% protein. along with 240 ml of coffee with 6 mg/caffeine/kg body weight or the same breakfast, but with 240 ml of water.
On an empty stomach and every 30 min during the 3 h following the consumption of breakfast with the beverage, the participants recorded their level of hunger, fullness, satiety, desire to eat and prospective consumption, desire to eat specific foods: sweet, salty, fatty, tasty, and sed through visual analog scales (VAS).
On an empty stomach, 30 minutes after consuming breakfast with the beverage and after 180 min, a blood sample will be taken from which serum will be obtained for glucose, total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, triglycerides, ghrelin and cholecystokinin determinations.
In the first intervention, participants will be instructed to fill out a 24-hour reminder form to assess dietary intake, and will be asked to record all food and beverages consumed for 3 days prior to the two interventions. Participants will also be instructed to fill out a 24-hour post-breakfast reminder with or without coffee.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover randomized clinical trial. Premenopausal women with overweight or with obesity will be included. The participants attend 3 sessions: in the first, a clinical history is applied, and anthropometric measurements are taken; in the second and third sessions they consume a standard breakfast (519 kcal) together with 240 ml of coffee with 6 mg/caffeine/kg of weight or the same breakfast but accompanied by 240 ml of water. The sequence of the type of intervention is randomly assign with a period of 1 week wash. Fasting and every 30 minutes during the 3 hours following breakfast consumption, sensations of appetite are recorded using visual analog scales. Fasting, 30 and 180 min after breakfast consumption, ghrelin and cholecystokinin levels are measured. Dietary intake is recorded on the day before the two interventions and on the day of intervention, after breakfast consumption.
| Arm | Type | Receives |
|---|---|---|
| breakfast with coffee | Experimental | Other: breakfast with coffee250 mL of water with 6 mg/caffeine/kg |
| breakfast with water | Placebo comparator | Other: breakfast with water250 mL of water |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women between 20 and 40 years old
- Body mass index between 25-40 kg/m2.
- Regular menstrual cycle of 23-32 days in the last 3 months.
- Moderate consumption of coffee (up to 4 cups per day)
- Having the habit of eating breakfast
Key exclusion criteria (8 listed)
- Use of any type of contraceptives in the last three months.
- Use of hypoglycemic, lipid-lowering, weight-loss, appetite altering and psychiatric medications.
- Diagnosis of diabetes mellitus, hypertension, cancer, polycystic ovary syndrome, hypothyroidism, hyperthyroidism, infectious disease, renal disease, dysgeusia, and gallbladder disease.
- Weight loss ≥5% of their weight in the last 6 months.
- Consumption of more than 20 g of alcohol per day.
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 |
|---|---|---|
| breakfast with coffeebreakfast with coffee with 6 mg/caffeine/kg body weight | Other | breakfast with coffee |
| breakfast with waterbreakfast with 250 mL of water | Other | breakfast with water |
Primary outcome
Change in ghrelin concentration
Time frame: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
Ghrelin hormone measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is GHRL/Ghrelin ELISA Kit catalog number ELH-GHRL. Ghrelin is measured in pg/mL.
Change in cholecystokinin concentration
Time frame: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
Cholecystokinin measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations. The kit is Human CCK Enzyme Immunoassay Kit catalog number EIA-CCK-1. Cholecystokinin is measured in pg/mL.
Change in dietary intake
Time frame: Post intervention, the following 24 hours after finishing the intervention
Analysis of the 24 hour dietary intake recall consumed the rest of the day after the intervention. Analyzed with the Nutritionist Pro TM Software.
Change in appetite feelings
Time frame: Baseline and in the following 180 minutes postprandially, measured every 30 minutes.
Hunger, fullness, satiety, desire to eat and prospective consumption are assessed with the visual analog scales (VAS). They are composed of 100 mm long lines, where at one end the term "None" or "Not at all" is placed and at the other end the term "Yes, a lot" or "As much as I have never felt". The patient marks a point between these two extremes and quantification is done by measuring the distance from the left end of the line to the mark which is scored.
Change in desire for specific types of food
Time frame: Baseline and in the following 180 minutes postprandially, measured every 30 minutes.
The desire to eat specific foods: sweet, salty, fatty, tasty and thirsty, was evaluated with visual analog scales, consisting of lines in which at one end is placed the term "Yes, very much" and at the other end the term "No, not at all". The patient marks a point between these two extremes and quantification is done by measuring the distance from the left end of the line to the mark, to which a score is given.
4 secondary outcomes
Change in plasma glucose
Time frame: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
Change in lipid profile: total cholesterol, triglycerides, high density lipoprotein, low-density lipoprotein, very low-density lipoprotein
Time frame: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
24 hour dietary intake recall pre-intervention
Time frame: Baseline
Physical activity
Time frame: Baseline
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 14 Feb 2024.
- Derived from this study: PubMed 38986627Magana-de la Vega L, Martinez-Lopez E, Sanchez-Murguia T, Madrigal-Juarez A, Rodriguez-Reyes SC, Aguilar-Vega I, Torres-Castillo N. Effect of coffee intake on appetite parameters in woman with overweight or obesity: A pilot crossover randomized trial. Endocrinol Diabetes Nutr (Engl Ed). 2024 Jun-Jul;71(6):236-245. doi: 10.1016/j.endien.2024.03.021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breakfast with coffee and breakfast with water in people with Obesity, run by University of Guadalajara at 1 site in Mexico.
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 6 inclusion and 8 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 14 Feb 2024. 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 Mexico. 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. Some participants in this study may receive a placebo. 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?
Change in ghrelin concentration (time frame: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.). The study lists 5 primary outcomes in all. 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 NCT05774119, 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 14 Feb 2024.