Ignite Creation Date:
2024-05-06 @ 6:11 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05573438
Status:
COMPLETED
Last Update Posted:
2022-10-10
First Post:
2022-09-22
Brief Title:
Acute Inflammatory and Metabolic Effect of High Fructose Intake
Sponsor:
Adaliene Versiani M Ferreira
Organization:
Federal University of Minas Gerais
Study Overview
Official Title:
Acute Inflammatory and Metabolic Effect of High Fructose Intake in Normal Weight Women Double Blind Randomized Crossover Study
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fructose consumption is associated with the development of metabolic diseases and low-grade inflammation However the acute effect of a single meal rich in fructose on the metabolic and inflammatory response is not fully understood This study will to evaluate the acute metabolic and inflammatory effect caused by a meal containing fructose overload This will be a three-arm crossover randomized double-blind clinical trial
Participants will undergo the three interventions for random order i standardized meal plus sucrose overload ii standardized meal plus glucose overload iii standardized meal plus fructose overload During the washout period 7 to 21 days the subjects will instructed to maintain their usual eating behavior and physical activity
On the day of each intervention participants will to the outpatient clinic in the morning after an overnight fast Anthropometric data weight height and waist circumference will collected Body composition will evaluated using bioimpedance Quantum apparatus RJM Systems Michigan and blood pressure and heart rate digital monitor model HEM705CP Omron will measured after 30 minutes of rest
A catheter with a three-way stopcock will inserted into the arm of the volunteers Blood samples 5mL will collected after overnight fasting baseline and 30 60 120 and 240 minutes after the standardized meal containing sucrose or glucose or fructose overload Participants will remain seated throughout the evaluation period Participants will receive a standardized meal of bread ham and margarine plus a sweetened drink 200mL with similar amounts of different carbohydrates sucrose glucose or fructose in each intervention The meals will provide 25 of the energy requirements calculated from the resting energy expenditure measured by indirect calorimetry KORR MetaCheck multiplied by the activity factor plus 10 referring to the thermal effect of food The meal will consiste of 15 of protein 30 of fat and 55 of carbohydrate 30 of complex carbohydrates and 25 of sucrose or glucose or fructose
Serum levels of glucose triglycerides total cholesterol alanine aminotransferase ALT and aspartate aminotransferase AST will be measured by colorimetric enzymatic test Serum levels of adiponectin leptin resistin and TNF will be measured by Enzyme Linked ImmuneSorbent Assay ELISA Serum levels of IL-2 IL-4 IL-5 IL-6 IL-10 IL-17 IFN-γ and eotaxin will be obtained by the Cytometric Bead Array CBA
Participants will undergo the three interventions for random order i standardized meal plus sucrose overload ii standardized meal plus glucose overload iii standardized meal plus fructose overload During the washout period 7 to 21 days the subjects will instructed to maintain their usual eating behavior and physical activity
On the day of each intervention participants will to the outpatient clinic in the morning after an overnight fast Anthropometric data weight height and waist circumference will collected Body composition will evaluated using bioimpedance Quantum apparatus RJM Systems Michigan and blood pressure and heart rate digital monitor model HEM705CP Omron will measured after 30 minutes of rest
A catheter with a three-way stopcock will inserted into the arm of the volunteers Blood samples 5mL will collected after overnight fasting baseline and 30 60 120 and 240 minutes after the standardized meal containing sucrose or glucose or fructose overload Participants will remain seated throughout the evaluation period Participants will receive a standardized meal of bread ham and margarine plus a sweetened drink 200mL with similar amounts of different carbohydrates sucrose glucose or fructose in each intervention The meals will provide 25 of the energy requirements calculated from the resting energy expenditure measured by indirect calorimetry KORR MetaCheck multiplied by the activity factor plus 10 referring to the thermal effect of food The meal will consiste of 15 of protein 30 of fat and 55 of carbohydrate 30 of complex carbohydrates and 25 of sucrose or glucose or fructose
Serum levels of glucose triglycerides total cholesterol alanine aminotransferase ALT and aspartate aminotransferase AST will be measured by colorimetric enzymatic test Serum levels of adiponectin leptin resistin and TNF will be measured by Enzyme Linked ImmuneSorbent Assay ELISA Serum levels of IL-2 IL-4 IL-5 IL-6 IL-10 IL-17 IFN-γ and eotaxin will be obtained by the Cytometric Bead Array CBA
Detailed Description:
This will be a three-arm crossover randomized double-blind clinical trial performed at the Alpha Institute of Gastroenterology of the Hospital das Clínicas Belo Horizonte MG Brazil All experimental procedures will be conducted according to the guidelines laid down in the Declaration of Helsinki The research protocol was approved by the Institutional Review Board of the Universidade Federal de Minas Gerais CAAE 21852314700005149 All volunteers will signed the informed consent prior to the start of the study
Sample The sample size of 17 subjects was calculated considering the minimum number of participants to detect a difference of at least 11 mgdL in the levels of triglycerides 12 ngmL in adiponectin and 19 pgmL in TNF pilot study before and after the intake of a single meal containing a fructose overload 95 confidence interval and statistical power of the 80
Study design Each participant will in three visits with washout period between 7 and 21 days At each visit the participant will pass by a different intervention Three interventions will curr in random order i standardized meal plus sucrose overload ii standardized meal plus glucose overload iii standardized meal plus fructose overload During the washout period the subjects will instructed to maintain their usual eating behavior and physical activity Participants will instructed to avoid consuming caffeine and alcoholic beverages and perform intense physical activity within 24 hours before each visit
On the day of each intervention participants will go to the outpatient clinic in the morning after an overnight fast Anthropometric data weight height and waist circumference will collected Body composition will evaluated using bioimpedance Quantum apparatus RJM Systems Michigan and blood pressure and heart rate digital monitor model HEM705CP Omron will measured after 30 minutes of rest
A catheter with a three-way stopcock will inserted into the arm of the volunteers Blood samples 5mL will collected after overnight fasting baseline and 30 60 120 and 240 minutes after the standardized meal containing sucrose or glucose or fructose overload Participants remained seated throughout the evaluation period
Intervention Participants will receive a standardized meal of bread ham and margarine plus a sweetened drink 200mL with similar amounts of different carbohydrates sucrose glucose or fructose in each intervention The meals will provide 25 of the energy requirements calculated from the resting energy expenditure measured by indirect calorimetry KORR MetaCheck multiplied by the activity factor plus 10 referring to the thermal effect of food The meal will consiste of 15 of protein 30 of fat and 55 of carbohydrate 30 of complex carbohydrates and 25 of sucrose or glucose or fructose The sweetened drinks will have artificial fruit flavor to avoid the identification of the content by the researchers and the volunteers
The amount of refined offered carbohydrates to the participants 18 - 25g in a single meal will considered an overload since the World Health Organization and the National Center for Chronic Disease Prevention and Health Promotion recommend that the consumption of added sugars should not exceed 10 of the total daily calories For example in a 2000 caloric diet no more than 200 calories should come from added sugars about 12 teaspoons In addition several authors who investigated short- and long-term 3 weeks fructose consumption in metabolic and inflammatory biomarkers offered 25 of total energy expenditure GET in the form of sucrose glucose fructose or high fructose corn syrup per day On the other hand the amount of these carbohydrates offered in the present study is part of the eating routine of many individuals eg 200mL of regular soda contains 21 grams of sucrose
Blood analysis Serum levels of glucose triglycerides total cholesterol alanine aminotransferase ALT and aspartate aminotransferase AST will measured by colorimetric enzymatic test Bioclin Belo Horizonte MG Brazil Serum levels of adiponectin leptin resistin and TNF will measured by Enzyme Linked ImmuneSorbent Assay ELISA following the manufacturers instructions RD Systems Serum levels of IL-2 IL-4 IL-5 IL-6 IL-10 IL-17 IFN-γ and eotaxin will obtained by the Cytometric Bead Array CBA method BD Bioscience San Diego CA USA in flow cytometry Collected blood will diluted in Turks solution The number of total white blood cell will obtained using a Neubauer chamber 40 objective
Statistical Analyses All quantitative variables will present as mean standard error SEM The normality of the quantitative variables will tested through the Shapiro-Wilk test Students t Simple and Mann-Whitney tests will allow comparisons between the initial characteristics of those who completed the study and those who did not and between volunteers who will participate in the sub-sample and those who not To compare the anthropometric and clinical characteristics between baseline and the subsequent assessments we will use the ANOVA test for repeated measures 1-factor or Kruskal-Wallis according to the normality followed by Bonferroni post-test Postprandial metabolic and inflammatory markers will compared by the Generalized Equation of Estimates GEE model to evaluate the effect of group allocation carbohydrate type time and adjusting for time-group effect interaction The variables will treated with the connection range function and the correlation matrix will the covariance of an unstructured and robust estimator The Bonferroni post-test will identifie the presence of signifcant effects Significance will set at P 005 The data will analysed using the Statistical Package for the Social Sciences SPSS software version 20 and GraphPad Prism version 50
Sample The sample size of 17 subjects was calculated considering the minimum number of participants to detect a difference of at least 11 mgdL in the levels of triglycerides 12 ngmL in adiponectin and 19 pgmL in TNF pilot study before and after the intake of a single meal containing a fructose overload 95 confidence interval and statistical power of the 80
Study design Each participant will in three visits with washout period between 7 and 21 days At each visit the participant will pass by a different intervention Three interventions will curr in random order i standardized meal plus sucrose overload ii standardized meal plus glucose overload iii standardized meal plus fructose overload During the washout period the subjects will instructed to maintain their usual eating behavior and physical activity Participants will instructed to avoid consuming caffeine and alcoholic beverages and perform intense physical activity within 24 hours before each visit
On the day of each intervention participants will go to the outpatient clinic in the morning after an overnight fast Anthropometric data weight height and waist circumference will collected Body composition will evaluated using bioimpedance Quantum apparatus RJM Systems Michigan and blood pressure and heart rate digital monitor model HEM705CP Omron will measured after 30 minutes of rest
A catheter with a three-way stopcock will inserted into the arm of the volunteers Blood samples 5mL will collected after overnight fasting baseline and 30 60 120 and 240 minutes after the standardized meal containing sucrose or glucose or fructose overload Participants remained seated throughout the evaluation period
Intervention Participants will receive a standardized meal of bread ham and margarine plus a sweetened drink 200mL with similar amounts of different carbohydrates sucrose glucose or fructose in each intervention The meals will provide 25 of the energy requirements calculated from the resting energy expenditure measured by indirect calorimetry KORR MetaCheck multiplied by the activity factor plus 10 referring to the thermal effect of food The meal will consiste of 15 of protein 30 of fat and 55 of carbohydrate 30 of complex carbohydrates and 25 of sucrose or glucose or fructose The sweetened drinks will have artificial fruit flavor to avoid the identification of the content by the researchers and the volunteers
The amount of refined offered carbohydrates to the participants 18 - 25g in a single meal will considered an overload since the World Health Organization and the National Center for Chronic Disease Prevention and Health Promotion recommend that the consumption of added sugars should not exceed 10 of the total daily calories For example in a 2000 caloric diet no more than 200 calories should come from added sugars about 12 teaspoons In addition several authors who investigated short- and long-term 3 weeks fructose consumption in metabolic and inflammatory biomarkers offered 25 of total energy expenditure GET in the form of sucrose glucose fructose or high fructose corn syrup per day On the other hand the amount of these carbohydrates offered in the present study is part of the eating routine of many individuals eg 200mL of regular soda contains 21 grams of sucrose
Blood analysis Serum levels of glucose triglycerides total cholesterol alanine aminotransferase ALT and aspartate aminotransferase AST will measured by colorimetric enzymatic test Bioclin Belo Horizonte MG Brazil Serum levels of adiponectin leptin resistin and TNF will measured by Enzyme Linked ImmuneSorbent Assay ELISA following the manufacturers instructions RD Systems Serum levels of IL-2 IL-4 IL-5 IL-6 IL-10 IL-17 IFN-γ and eotaxin will obtained by the Cytometric Bead Array CBA method BD Bioscience San Diego CA USA in flow cytometry Collected blood will diluted in Turks solution The number of total white blood cell will obtained using a Neubauer chamber 40 objective
Statistical Analyses All quantitative variables will present as mean standard error SEM The normality of the quantitative variables will tested through the Shapiro-Wilk test Students t Simple and Mann-Whitney tests will allow comparisons between the initial characteristics of those who completed the study and those who did not and between volunteers who will participate in the sub-sample and those who not To compare the anthropometric and clinical characteristics between baseline and the subsequent assessments we will use the ANOVA test for repeated measures 1-factor or Kruskal-Wallis according to the normality followed by Bonferroni post-test Postprandial metabolic and inflammatory markers will compared by the Generalized Equation of Estimates GEE model to evaluate the effect of group allocation carbohydrate type time and adjusting for time-group effect interaction The variables will treated with the connection range function and the correlation matrix will the covariance of an unstructured and robust estimator The Bonferroni post-test will identifie the presence of signifcant effects Significance will set at P 005 The data will analysed using the Statistical Package for the Social Sciences SPSS software version 20 and GraphPad Prism version 50
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None