Effect of Coffee Consumption on Appetite Traits in Overweight and Obesity

NCT ID: NCT05774119

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-09-01

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

breakfast with coffee

250 mL of water with 6 mg/caffeine/kg

Group Type: EXPERIMENTAL

breakfast with coffee

Intervention Type: OTHER

breakfast with coffee with 6 mg/caffeine/kg body weight

breakfast with water

250 mL of water

Group Type: PLACEBO_COMPARATOR

breakfast with water

Intervention Type: OTHER

breakfast with 250 mL of water

Interventions

breakfast with coffee

breakfast with coffee with 6 mg/caffeine/kg body weight

Intervention Type: OTHER

breakfast with water

breakfast with 250 mL of water

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Livier Nathaly Torres Castillo

Associate Professor B

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad de Guadalajara

Guadalajara, Jalisco, Mexico

Countries

Mexico

References

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.

Reference Type: DERIVED

PMID: 38986627 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

CI-03421

Identifier Type: -

Identifier Source: org_study_id