Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638190
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Influence of the Fruit Matrix on Glucose and Insulin Responses After the Intake of Orange Juice in Healthy Human Males
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Role of the Fruit Matrix on the Absorption of Glucose From Orange Juice in Humans
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
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:
ZULEMA
Brief Summary:
QUALIFICATION Role of the fruit matrix in glucose absorption from orange juice in healthy human volunteers
MAIN OBJECTIVE
Added sugars may have different effects on glycemic response than natural sugars present in fruit juice The juice matrix fiber polyphenols citric acid vitamins minerals may positively influence this glycemic response The main objective of this project is to investigate how for the same qualitative and quantitative sugar composition the variation in the percentage of fruit matrix present in the juice may affect the glycemic response in healthy male participants
CLINICAL STUDY
This is a randomized double-blind dose-response crossover study in healthy male adult participants 18-45 years 185-299 kgm2 N30 The participants will repeat the entire study duplicate results to address interindividual variability and increase the reliability of the results Participants who agree to take part in the study will complete a series of validated questionnaires about their lifestyle habits The company AMC Natural Drinks Murcia Spain will prepare the following juices 100 orange juice versus 50 orange juice and 0 orange juice same sugar composition as 100 juice but with reduced or absent matrix respectively The drinks will be fully characterized in their composition
The day before each trial participants will complete a food diary to verify compliance with a polyphenol-free diet and estimate the amount of nutrients consumed carbohydrates fiber water They will arrive at the UCAM laboratory on an empty stomach where they will drink each of the juices on separate dates The researchers will measure glycemic response by finger prick and capillary blood sampling at baseline 0 min baseline and after the consumption of the drinks time points 15 30 45 60 90 and 120 minutes Results will be compared with the response to a single oral dose of glucose glycemic index The participants will repeat some of the test drinks total 6 interventions at least 2 or 3 days apart The researchers will also measure insulin at the same time points after drinking the test drinks and analyze the differences in the effects on glycemic and insulin responses between the three types of juices using appropriate statistical analysis
MAIN OBJECTIVE
Added sugars may have different effects on glycemic response than natural sugars present in fruit juice The juice matrix fiber polyphenols citric acid vitamins minerals may positively influence this glycemic response The main objective of this project is to investigate how for the same qualitative and quantitative sugar composition the variation in the percentage of fruit matrix present in the juice may affect the glycemic response in healthy male participants
CLINICAL STUDY
This is a randomized double-blind dose-response crossover study in healthy male adult participants 18-45 years 185-299 kgm2 N30 The participants will repeat the entire study duplicate results to address interindividual variability and increase the reliability of the results Participants who agree to take part in the study will complete a series of validated questionnaires about their lifestyle habits The company AMC Natural Drinks Murcia Spain will prepare the following juices 100 orange juice versus 50 orange juice and 0 orange juice same sugar composition as 100 juice but with reduced or absent matrix respectively The drinks will be fully characterized in their composition
The day before each trial participants will complete a food diary to verify compliance with a polyphenol-free diet and estimate the amount of nutrients consumed carbohydrates fiber water They will arrive at the UCAM laboratory on an empty stomach where they will drink each of the juices on separate dates The researchers will measure glycemic response by finger prick and capillary blood sampling at baseline 0 min baseline and after the consumption of the drinks time points 15 30 45 60 90 and 120 minutes Results will be compared with the response to a single oral dose of glucose glycemic index The participants will repeat some of the test drinks total 6 interventions at least 2 or 3 days apart The researchers will also measure insulin at the same time points after drinking the test drinks and analyze the differences in the effects on glycemic and insulin responses between the three types of juices using appropriate statistical analysis
Detailed Description:
Project proposal Role of the fruit matrix on the absorption of glucose from orange juice in humans ZULEMA
Background assumptions Excessive consumption of free sugars can have negative health effects and poor post-prandial control of glucose could be a marker for longer term type 2 diabetes risk Sugars drive the glycemic index GI of beverages but contrary to expectations fruit juices and sugar-sweetened beverages provide different GI results despite often having the same total sugar content This implies that natural and added sugars may have different effects on glycemic control or that the combination of sugars within the juice matrix is somehow ameliorating the effect of the sugars on glycemic control
Research question How does varying the matrix and source of sugars but not total sugars in fruit juices and drinks impact GI The researchers assume that the free sugars will be the driver of GI but this may not be the case
Hypothesis For the same amount of free sugars sucrose glucose and fructose in juices and beverages the fruits juice matrix ie fiber complex carbohydrates citric acid polyphenols and other phytochemicals minerals vitamins will have a modulatory effect on the absorption of glucose
Objective The primary objective of this study is to assess the effect of the presence of the juice matrix in 100 orange juice against manipulated juice drinks to reduce the percentage of fruit matrix on postprandial glycemia responses in healthy subjects The secondary objective will be to characterize the effect on the insulin response
Experimental design The glucose-responses will also be compared to that of glucose alone Glycemic Index GI
Methods
Juice preparation and logistics The orange drinks will be produced and supplied by AMC Natural Drinks Murcia Spain A 100 fruit juice orange juice will be compared with drinks containing 50 and 0 of juice although with the same total sugar qualitative and quantitative composition sucrose fructose glucose as in the 100 juice
Chemical analyses
The researchers will characterize the sugar composition and the main fruit matrix components
Soluble and insoluble fiber chemical analysis
Sugars analysis The juices will be manufactured and the sugar composition sucrose glucose and fructose measured and adjusted to make sure that the sugar content does not changed during the storage period Analyses will be performed by High Performance Liquid Chromtagraphy HPLC using the appropriate Refractive Index RI detectors
Phytochemicals analysis Individual phenolics and other phytochemicals characteristic of orange juice Flavanones polymethoxyflavones hydroxycinnamic acid derivatives flavones carotenoids will be analysed using reversed phase HPLC with Ultraviolet-Diode Array UV-DAD detectors and Mass Spec MS detectors
Clinical trial
This study is a crossover randomized double-blind dose-response intervention trial All participants will repeat the study in separate times to attain duplicate results The study protocol has been already approved by the Catholic University Ethical Committee
Participants Inclusion and Exclusion Criteria
The researchers will recruit male healthy adults aged 18 to 45 years of age via online classified advertisements social media and by word-of-mouth Females are not eligible since menstrual cycle can influence glycaemic control To meet the inclusion criteria the participants will be required to have Body a Mass Index BMI between 185 and 299 kgm2 to be habitual breakfast consumers and to be willing to consume the study beverages Participants will be excluded if they are on a diet or have food allergies or aversion to the drinks of the study Furthermore participants will be excluded if they had significant weight fluctuations within the past 6 months or a previous diagnosis of diabetes pre-diabetes gastrointestinal disease liver disease kidney disease or a metabolic disorder
Sample size
The researchers estimated the sample size for a randomized crossover study in which the effects of the intervention different test orange drinks will be tested in a healthy adult sample population For this purpose the researchers used the free available software GPower 3197 assuming a two-tails statistical power of 90 1-β090 a level of statistical significance of 5 α005 and an effect size of d07 According to this the minimum number of participants in the study should be N24 These participants should also take part in the second round of tests duplicate results The final number of participants was increased up to 30 to count for potential withdrawals
Study Consent
A telephone screening interview will provide initial eligibility criteria Participants who pass the telephone screening will be scheduled to attend an in-person information and final screening session at the laboratory to review study protocols and obtain written informed consent The researchers will take some anthropometric measures and will explain to the participants the intervention and procedures during the whole study The participants will also complete a series of general validated questionnaires about their dietary and lifestyle habits
Intervention Design
Eligible participants will complete four test sessions two repetitions at least 2-3 day apart On separate mornings participants will arrive at the laboratory at 800 am following a 10 to 12 h fast except for a small amount of water which will be permitted up to 1 h before arriving On the day before to each test session the participants will complete a food diary to verify adherence to the polyphenol-free and citric fruits-free diet fasting protocol and to estimate the amount of nutrients consumed principally total carbohydrates free sugars fiber and water
The participants will rapidly within five minutes consume one of the three drinks 1 100 orange juice 2 orange beverage with 50 orange juice and 50 water with added sugars to match the content of the 100 juice and 3 100 water with added sugars to match the content of the 100 juice Standard serving sizes around 250 mL will be calculated on the basis of total available carbohydrate to reach an intake of 25 g of free sugars In addition the participants will also consume a glucose solution 25 g to estimate the GI All test drinks will be served cold in opaque containers with lids Glycemic response will be measured by finger-prick at baseline 0 minutes and 15 30 45 60 90 and 120 minutes post-consumption of the drink
After completion of the study the participants will have a 2-3 weeks rest and will come back to the laboratory for a second test session The aim of this repetition is to have amore robust analysis of the results and evaluate intra- and interindividual variability
Post-Prandial Glycemic Response
The researchers will collect capillary blood glucose samples from fingertips via a single-use auto-disabling lancets Softclix lancets Roche and will measure glucose immediately by means of a glucometer Accu-Check Guide Me Roche
Insulin measurement
Additional samples of blood will be collected from the vein After centrifugation 1200-1500 g 10 min 4 ºC the serum samples will be rapidly frozen and kept at -80 ºC until analysis of insulin levels Insulin will be measured using an ELISA test system Accu Bind ELISA Microwells Monobind Inc CA USA
Statistical Analyses
Statistical analyses will be performed using SAS version 94 A repeated-measures two-factor analysis of variance ANOVA using the PROC MIXED procedure will be used to determine the effect of the intervention ie test beverage on blood glucose levels To determine the effect of treatment on blood glucose incremental area under the curve iAUC a one-factor repeated measures ANOVA will be used A p-value 005 will be considered statistically significant
Background assumptions Excessive consumption of free sugars can have negative health effects and poor post-prandial control of glucose could be a marker for longer term type 2 diabetes risk Sugars drive the glycemic index GI of beverages but contrary to expectations fruit juices and sugar-sweetened beverages provide different GI results despite often having the same total sugar content This implies that natural and added sugars may have different effects on glycemic control or that the combination of sugars within the juice matrix is somehow ameliorating the effect of the sugars on glycemic control
Research question How does varying the matrix and source of sugars but not total sugars in fruit juices and drinks impact GI The researchers assume that the free sugars will be the driver of GI but this may not be the case
Hypothesis For the same amount of free sugars sucrose glucose and fructose in juices and beverages the fruits juice matrix ie fiber complex carbohydrates citric acid polyphenols and other phytochemicals minerals vitamins will have a modulatory effect on the absorption of glucose
Objective The primary objective of this study is to assess the effect of the presence of the juice matrix in 100 orange juice against manipulated juice drinks to reduce the percentage of fruit matrix on postprandial glycemia responses in healthy subjects The secondary objective will be to characterize the effect on the insulin response
Experimental design The glucose-responses will also be compared to that of glucose alone Glycemic Index GI
Methods
Juice preparation and logistics The orange drinks will be produced and supplied by AMC Natural Drinks Murcia Spain A 100 fruit juice orange juice will be compared with drinks containing 50 and 0 of juice although with the same total sugar qualitative and quantitative composition sucrose fructose glucose as in the 100 juice
Chemical analyses
The researchers will characterize the sugar composition and the main fruit matrix components
Soluble and insoluble fiber chemical analysis
Sugars analysis The juices will be manufactured and the sugar composition sucrose glucose and fructose measured and adjusted to make sure that the sugar content does not changed during the storage period Analyses will be performed by High Performance Liquid Chromtagraphy HPLC using the appropriate Refractive Index RI detectors
Phytochemicals analysis Individual phenolics and other phytochemicals characteristic of orange juice Flavanones polymethoxyflavones hydroxycinnamic acid derivatives flavones carotenoids will be analysed using reversed phase HPLC with Ultraviolet-Diode Array UV-DAD detectors and Mass Spec MS detectors
Clinical trial
This study is a crossover randomized double-blind dose-response intervention trial All participants will repeat the study in separate times to attain duplicate results The study protocol has been already approved by the Catholic University Ethical Committee
Participants Inclusion and Exclusion Criteria
The researchers will recruit male healthy adults aged 18 to 45 years of age via online classified advertisements social media and by word-of-mouth Females are not eligible since menstrual cycle can influence glycaemic control To meet the inclusion criteria the participants will be required to have Body a Mass Index BMI between 185 and 299 kgm2 to be habitual breakfast consumers and to be willing to consume the study beverages Participants will be excluded if they are on a diet or have food allergies or aversion to the drinks of the study Furthermore participants will be excluded if they had significant weight fluctuations within the past 6 months or a previous diagnosis of diabetes pre-diabetes gastrointestinal disease liver disease kidney disease or a metabolic disorder
Sample size
The researchers estimated the sample size for a randomized crossover study in which the effects of the intervention different test orange drinks will be tested in a healthy adult sample population For this purpose the researchers used the free available software GPower 3197 assuming a two-tails statistical power of 90 1-β090 a level of statistical significance of 5 α005 and an effect size of d07 According to this the minimum number of participants in the study should be N24 These participants should also take part in the second round of tests duplicate results The final number of participants was increased up to 30 to count for potential withdrawals
Study Consent
A telephone screening interview will provide initial eligibility criteria Participants who pass the telephone screening will be scheduled to attend an in-person information and final screening session at the laboratory to review study protocols and obtain written informed consent The researchers will take some anthropometric measures and will explain to the participants the intervention and procedures during the whole study The participants will also complete a series of general validated questionnaires about their dietary and lifestyle habits
Intervention Design
Eligible participants will complete four test sessions two repetitions at least 2-3 day apart On separate mornings participants will arrive at the laboratory at 800 am following a 10 to 12 h fast except for a small amount of water which will be permitted up to 1 h before arriving On the day before to each test session the participants will complete a food diary to verify adherence to the polyphenol-free and citric fruits-free diet fasting protocol and to estimate the amount of nutrients consumed principally total carbohydrates free sugars fiber and water
The participants will rapidly within five minutes consume one of the three drinks 1 100 orange juice 2 orange beverage with 50 orange juice and 50 water with added sugars to match the content of the 100 juice and 3 100 water with added sugars to match the content of the 100 juice Standard serving sizes around 250 mL will be calculated on the basis of total available carbohydrate to reach an intake of 25 g of free sugars In addition the participants will also consume a glucose solution 25 g to estimate the GI All test drinks will be served cold in opaque containers with lids Glycemic response will be measured by finger-prick at baseline 0 minutes and 15 30 45 60 90 and 120 minutes post-consumption of the drink
After completion of the study the participants will have a 2-3 weeks rest and will come back to the laboratory for a second test session The aim of this repetition is to have amore robust analysis of the results and evaluate intra- and interindividual variability
Post-Prandial Glycemic Response
The researchers will collect capillary blood glucose samples from fingertips via a single-use auto-disabling lancets Softclix lancets Roche and will measure glucose immediately by means of a glucometer Accu-Check Guide Me Roche
Insulin measurement
Additional samples of blood will be collected from the vein After centrifugation 1200-1500 g 10 min 4 ºC the serum samples will be rapidly frozen and kept at -80 ºC until analysis of insulin levels Insulin will be measured using an ELISA test system Accu Bind ELISA Microwells Monobind Inc CA USA
Statistical Analyses
Statistical analyses will be performed using SAS version 94 A repeated-measures two-factor analysis of variance ANOVA using the PROC MIXED procedure will be used to determine the effect of the intervention ie test beverage on blood glucose levels To determine the effect of treatment on blood glucose incremental area under the curve iAUC a one-factor repeated measures ANOVA will be used A p-value 005 will be considered statistically significant
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