Effect of Coffee Consumption on Appetite Traits in Overweight and Obesity

NCT05774119 | Completed DMC

• 1 other identifier: CI-03421
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

coffee; hunger; ghrelin; cholecystokinin

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Baseline and in the following 180 minutes postprandially, measured every 30 minutes.

Secondary Outcomes (4)

• Change in plasma glucose

  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

  Baseline, at 30 minutes postprandially, and at 180 minutes postprandially.

• 24 hour dietary intake recall pre-intervention

  Baseline

• Physical activity

  Baseline

Study Arms (2)

breakfast with coffee

EXPERIMENTAL

250 mL of water with 6 mg/caffeine/kg

Other: breakfast with coffee

breakfast with water

PLACEBO COMPARATOR

250 mL of water

Other: breakfast with water

Interventions

breakfast with coffee OTHER

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

breakfast with coffee

breakfast with water OTHER

breakfast with 250 mL of water

breakfast with water

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (1)

• 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.

  PMID: 38986627 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Breakfast; Coffee; Water

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Meals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor B

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: March 17, 2023
• Study Start: January 31, 2022
• Primary Completion: May 15, 2023
• Study Completion: September 1, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)