Clinical trial NCT05774119: Effect of Coffee Consumption on Appetite Traits in Overweight and Obesity
Official title: Effect of Coffee Consumption on Hunger, Satiety, and Appetite-regulating Hormones in Women With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: coffee
hunger
ghrelin
cholecystokinin
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 10
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in ghrelin concentration
timeFrame: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
measure: Change in cholecystokinin concentration
timeFrame: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
measure: Change in dietary intake
timeFrame: Post intervention, the following 24 hours after finishing the intervention
measure: Change in appetite feelings
timeFrame: Baseline and in the following 180 minutes postprandially, measured every 30 minutes.
measure: Change in desire for specific types of food
timeFrame: Baseline and in the following 180 minutes postprandially, measured every 30 minutes.
Secondary outcomes:
measure: Change in plasma glucose
timeFrame: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
measure: Change in lipid profile: total cholesterol, triglycerides, high density lipoprotein, low-density lipoprotein, very low-density lipoprotein
timeFrame: Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
measure: 24 hour dietary intake recall pre-intervention
timeFrame: Baseline
measure: Physical activity
timeFrame: Baseline
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Universidad de Guadalajara
state: Jalisco
Study officials:
References: