Clinical trial NCT06527209: Effect of Coffee and Agave Inulin-based Beverage on Appetite in Adults With Obesity.
Official title: Chemical and Sensory Characterization of a Drink Based on Coffee and Agave Inulin and Its Effect on Appetite, Dietary Intake, and Biochemical Profile in Subjects With Obesity
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity
Keywords: coffee
agave inulin
obesity
ghrelin
GLP-1
PYY
appetite
visual analogue scale
specific sensory satiety
sensory specific desire
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
Collaborators: name: Hospital Civil de Guadalajara
First posted: 2024-07-30
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will be assigned to the two interventions separately according to the random assignment sequence corresponding to the crossover design. The interventions consist of a control beverage or a coffee and inulin-based beverage. The beverage will consumed daily 30 minutes before breakfast for two weeks with a two-week washout period.
Primary purpose: BASIC_SCIENCE

Brief summary: Nutritional treatment is key in managing obesity; however, the lack of fullness or satiety signals may affect adherence to this treatment. Coffee and inulin consumption, separately, have been shown to increase satiety and GLP-1 concentrations and reduce appetite and energy intake, but they have not been evaluated together. It is necessary to obtain scientific evidence contributing to recommendations for controlling appetite in an obesity context.

Therefore, this study aims to analyze the use of coffee and agave inulin-based beverage consumption on appetite sensations, dietary intake, and ghrelin, GLP-1, and PYY concentrations in adults with obesity.

For that purpose, a double-blind, randomized crossover clinical trial was designed to evaluate the effect of daily consumption, during two weeks, of a coffee and inulin-based beverage compared to a control beverage. Appetite sensations will be analyzed with visual analogue scales, dietary intake with a 3-day self-reporting of food intake, and appetite hormones with ELISA assays. The measurements will be performed in 6 scheduled sessions. In each session, fasting and postprandial appetite variables will be evaluated.

Detailed description: In Mexico, obesity has not ceased to increase since 1988, when it had a prevalence of only 9.5% compared to the 36.1% recorded in 2018, so it is necessary to start acting for the welfare of the Mexican population. In the search for a tool to complement nutritional intervention, we found coffee and inulin. Coffee consumption in our country increases 2% each year and according to data from PROFECO (Procuraduría Federal del Consumidor), 85% of Mexicans beverage one to three cups a day.

Agave tequilana Weber, a blue variety, is the most widely cultivated of the 117 species of agaves native to Mexico, a variety that is an important source of inulin.

Based on previous research, these two products of the Mexican countryside have been shown to provide health benefits, each in their own right. In the case of coffee, it has been shown to improve endurance and exercise capacity, has antioxidant capacity, has been associated with a lower risk of Parkinson's and Alzheimer's disease, and several studies report a hepatoprotective effect. Regarding appetite control and weight loss, there is still great controversy within the scientific community about its effects, especially due to the lack of randomized clinical trials. Inulin has been shown to improve intestinal transit, lower LDL cholesterol, and be an important prebiotic for the intestinal microbiota. However, its relationship with appetite control is unclear. These effects on regulating appetite processes such as hunger and satiety have been studied in other countries, but not in Mexico, and much less so using inulin from agave tequilana Weber.

Part of this project is to design a beverage based on coffee and agave inulin that provides health benefits, but that is also to the taste and consumption preferences of the population so that it can be easily included as part of their regular diet, that has a low energy content and also contains the necessary amount of bioactive compounds that have proven to have beneficial effects on health, and that could have an improvement in appetite control, according to the background that has been reported. All this is supported by the clinical trial proposed in this research project. In addition, this beverage could represent an option of an accessible food that could be a healthy alternative to sugary beverages with low fiber intake that are consumed with great demand in our country.

Objective: To evaluate the chemical and sensory characteristics of coffee and agave inulin-based beverages and their effects on appetite, dietary intake, and biochemical profiles in subjects with obesity.

Type of study: Double-blind, randomized crossover clinical trial

All participants will be assigned to two interventions separately, according to the random assignment sequence corresponding to the crossover design.

The interventions consist of consuming a beverage (intervention or placebo) daily 30 minutes before breakfast for two weeks, with an intermediate washout period of 2 weeks between each treatment. Participants will be assigned randomly to the sequence AB (intervention beverage/placebo) or BA (placebo/intervention beverage) by generating a table of random numbers in the SPSS software.

Subjects who attend the Bariatric and Metabolic Surgery Unit of the Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca" and who meet the selection criteria. Subjects attend six sessions, one each week.

Eligibility criteria: Inclusion Criteria:

* Men and women
* 25 to 55 years of age
* BMI ≥ 30 and \<35 kg/m2
* Habitual coffee consumption (1 - 3 cups of 240 ml of coffee per day)
* Willingness to stop consuming food and/or supplements with coffee, caffeine and/or inulin during the study with the exception of the intervention
* Availability of time in the mornings
* Residents of the Guadalajara Metropolitan Area
* Signed informed consent form

Exclusion Criteria:

* Hypersensitivity or intolerance to coffee or inulin
* Allergy or intolerance to any of the test foods
* Current or within the last 6 months use of weight-loss or appetite altering medications appetite altering medications
* Diagnosis of diabetes, hypertension or any heart disease, thyroid disease, infectious disease (COVID-19, flu, etc.), digestive or inflammatory bowel disease or dysgeusia
* Smoking
* Women who are pregnant, want to become pregnant, or are breastfeeding
* Peri-menopausal or menopausal women
* Who are on any dietary regimen for weight loss
* Currently or within the last 12 months participated in another study
* Consumption of prebiotics or probiotics in the last three months
* Incomplete data and/or measurements
* Lack of expected compliance (drinking at least 5 of the 7 days of each week is considered compliance).
* Individuals who decide to leave the study

Primary outcomes:
measure: Comparison of the subjective appetite sensations when consuming the intervention beverage vs. the control beverage.
timeFrame: Basally and two weeks after taking the intervention beverage. Basally and two weeks after taking the control beverage. In total, on four occasions. And on each occasion, they will be measured at times -30, 0 (beverage consumption), 30, and 60 minutes.
measure: Comparison of acylated ghrelin concentrations when consuming the intervention drink vs. the control drink.
timeFrame: Basally and two weeks after taking the intervention drink. Basally and two weeks after taking the control drink. In total, on four occasions. And on each occasion, it will be measure at -30 and 30 minutes after consumption of the beverage
measure: Comparison of the glucagon-like peptide 1 (GLP-1) levels when consuming the intervention beverage vs. the control beverage.
timeFrame: Basally and two weeks after taking the intervention drink. Basally and two weeks after taking the control drink. In total, on four occasions. And on each occasion, it will be measured at times -30 and 30 minutes after consumption of the beverage.
measure: Comparison of the PYY levels when consuming the intervention beverage vs. the control beverage.
timeFrame: Basally and two weeks after taking the intervention drink. Basally and two weeks after taking the control drink. In total, on four occasions. And on each occasion, it will be measured at times -30 and 30 minutes after the beverage consumption.
measure: Comparison of dietary intake when consuming the intervention beverage vs. the control beverage.
timeFrame: 3 days, being a weekday, a weekend day, and the day before the session
measure: Comparison of liking and wanting for specific foods when consuming the intervention beverage vs. the control beverage.
timeFrame: Basally and two weeks after taking the intervention beverage. Basally and two weeks after taking the control beverage. In total, on four occasions. And on each occasion, they will be measured at times -30, 0 (beverage consumption), 30, and 60 minutes.
measure: Comparison of specific sensory desire when consuming the intervention beverage vs. the control beverage.
timeFrame: Basally and two weeks after taking the intervention drink. Basally and two weeks after taking the control drink. In total, on four occasions. And on each occasion, they will be measured at -30, 0 (beverage consumption), 30, 30 and 60 minutes.
measure: Comparison of food choice when consuming the intervention beverage vs. the control beverage.
timeFrame: Basally and two weeks after taking the intervention drink. Basally and two weeks after taking the control drink. In total, on four occasions. And on each occasion, it will be measured at 60 minutes.
Secondary outcomes:
measure: Comparison of biochemical profile when consuming the intervention beverage vs. the control beverage.
timeFrame: Initially and two weeks after taking the intervention drink. Basally and two weeks after taking the control drink. In total, on four occasions. And on each occasion, it will be measured fasting and 30 minutes after consumption of the beverage
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Universidad de Guadalajara
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Livier N Torres, Ph.D
role: STUDY_DIRECTOR
References: