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Effect of Coffee Consumption on Appetite Traits in Overweight and Obesity

Primary Purpose

Obesity

Status
Active
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
breakfast with coffee
breakfast with water
Sponsored by
University of Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring coffee, hunger, ghrelin, cholecystokinin

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad de Guadalajara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

breakfast with coffee

breakfast with water

Arm Description

250 mL of water with 6 mg/caffeine/kg

250 mL of water

Outcomes

Primary Outcome Measures

Change in appetite hormones
Measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations
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.
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.
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.

Secondary Outcome Measures

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).
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.
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.
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.

Full Information

First Posted
November 1, 2022
Last Updated
March 6, 2023
Sponsor
University of Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT05774119
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
coffee, hunger, ghrelin, cholecystokinin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
breakfast with coffee
Arm Type
Experimental
Arm Description
250 mL of water with 6 mg/caffeine/kg
Arm Title
breakfast with water
Arm Type
Placebo Comparator
Arm Description
250 mL of water
Intervention Type
Other
Intervention Name(s)
breakfast with coffee
Intervention Description
breakfast with coffee with 6 mg/caffeine/kg body weight
Intervention Type
Other
Intervention Name(s)
breakfast with water
Intervention Description
breakfast with 250 mL of water
Primary Outcome Measure Information:
Title
Change in appetite hormones
Description
Measured by ELISA assay (Enzyme-Linked ImmunoSorbent Assay) according to the manufacturer's recommendations
Time Frame
Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
Title
Change in dietary intake
Description
Analysis of the 24 hour dietary intake recall consumed the rest of the day after the intervention. Analyzed with the Nutritionist Pro TM Software.
Time Frame
Post intervention, the following 24 hours after finishing the intervention
Title
Change in appetite feelings
Description
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.
Time Frame
Baseline and in the following 180 minutes postprandially, measured every 30 minutes.
Title
Change in desire for specific types of food
Description
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.
Time Frame
Baseline and in the following 180 minutes postprandially, measured every 30 minutes.
Secondary Outcome Measure Information:
Title
Change in plasma glucose
Description
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).
Time Frame
Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
Title
Change in lipid profile: total cholesterol, triglycerides, high density lipoprotein, low-density lipoprotein, very low-density lipoprotein
Description
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.
Time Frame
Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.
Title
24 hour dietary intake recall pre-intervention
Description
Analysis of the 24 hour dietary intake recall consumed the day previous to the intervention. Analyzed with the Nutritionist Pro TM Software.
Time Frame
Baseline
Title
Physical activity
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Universidad de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Coffee Consumption on Appetite Traits in Overweight and Obesity

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