Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774119
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2022-11-01
Brief Title:
Effect of Coffee Consumption on Appetite Traits in Overweight and Obesity
Sponsor:
University of Guadalajara
Organization:
University of Guadalajara
Study Overview
Official Title:
Effect of Coffee Consumption on Hunger Satiety and Appetite-regulating Hormones in Women With Overweight or Obesity
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor increasing satiety The purpose of this trial is to evaluate the effect of 6 mgcaffeinekg 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 mgcaffeinekg 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
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 mgcaffeinekg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None