Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527209
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-03-01
Brief Title:
Effect of Coffee and Agave Inulin-based Beverage on Appetite in Adults With Obesity
Sponsor:
None
Organization:
None
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 95 compared to the 361 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 Parkinsons and Alzheimers 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 beverageplacebo or BA placebointervention 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
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 Parkinsons and Alzheimers 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 beverageplacebo or BA placebointervention 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None