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Effects of Exercise on Fructose-induced Postprandial Lipemia

Primary Purpose

Sedentary Lifestyle, Dyslipidemias, Lipid Metabolism Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FRUCTOSE
DEXTROSE
EXERCISE
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sedentary Lifestyle focused on measuring fat metabolism, fructose, exercise

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI (18,5 to 24,9 kg/m²)
  • Sedentary lifestyle (< 150 minutes exercise per week)
  • Fructose intake < 25g per day
  • Otherwise healthy

Exclusion Criteria:

  • Smoker
  • Drug user
  • Using some medicine
  • Fat metabolism disorders
  • Orthopedic disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    Active Comparator

    Arm Label

    FRUCTOSE

    DEXTROSE

    FRUCTEX

    Arm Description

    Day 0, 45 min in rest position. Day 1, High Fat Meal (HFM) consisted of macronutrients (50% fat, 40% carbohydrate and 10% protein) with a fructose-rich beverage (0.5 g / kg). Day 2, High Fat Meal (HFM) consisted of macronutrients (50% fat, 40% carbohydrate and 10% protein) with a dextrose-rich beverage (0.5 g / kg).

    Day 0, 45 min in rest position. Day 1, High Fat Meal (HFM) consisted of macronutrients (50% fat, 40% carbohydrate and 10% protein) with a dextrose-rich beverage (0.5 g / kg). Day 2, High Fat Meal (HFM) consisted of macronutrients (50% fat, 40% carbohydrate and 10% protein) with a dextrose-rich beverage (0.5 g / kg).

    Day 0, 45 min of 60%VO2peak aerobic exercise . Day 1, High Fat Meal (HFM) consisted of macronutrients (50% fat, 40% carbohydrate and 10% protein) with a fructose-rich beverage (0.5 g / kg). Day 2, High Fat Meal (HFM) consisted of macronutrients (50% fat, 40% carbohydrate and 10% protein) with a dextrose-rich beverage (0.5 g / kg).

    Outcomes

    Primary Outcome Measures

    Triglycerides
    Parameter was analyzed by Cobas C111
    VLDL
    Parameter was analyzed by ELISA

    Secondary Outcome Measures

    Glycemia
    Parameter was analyzed by Cobas C111
    Insulin
    Parameter was analyzed by Cobas C111
    HDL
    Parameter was analyzed by Cobas C111
    Non-HDL cholesterol
    Parameter was analyzed by formula

    Full Information

    First Posted
    May 4, 2017
    Last Updated
    May 31, 2017
    Sponsor
    Federal University of Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03173495
    Brief Title
    Effects of Exercise on Fructose-induced Postprandial Lipemia
    Official Title
    Effects of Exercise on Fructose-induced Postprandial Lipemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 10, 2016 (Actual)
    Primary Completion Date
    December 15, 2016 (Actual)
    Study Completion Date
    December 15, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Rio Grande do Sul

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Cardiovascular Diseases (CVDs) are the leading causes of death in the world and in Brazil. In 2001, 12.45 million deaths on the globe (21% of the total) were caused by some CVD. The composition of modern man's diet has changed drastically with the industrialization of food, resulting in the transition from a diet rich in fibers and complex carbohydrates to one with a high content of sugars and fats. Since the current dietary pattern is characterized by the consumption of three or more meals a day, containing a quantity of fat in the range of 20 to 70 g, individuals spend a large part of the day in the postprandial state, with continuous fluctuation of lipemia Over 18 hours. Food intake (postprandial state) is the dynamic, unstable response of the body that refers to rapid hormonal and lipoprotein remodeling. It is well established in the literature that high-fat meals (lipid overload) cause an increase in plasma triglycerides. Hypertriglyceridemia and / or elevated triglyceride-rich lipoproteins (LRT) (chylomicrons, VLDL and their remnants) in the postprandial state induces endothelial dysfunction via increased oxidative stress and is an independent risk factor for CVDs. Therefore, Postprandial Lipemia (PPL) is counted as an early marker of atherosclerotic process, metabolic abnormalities and endothelial dysfunction. High-carbohydrate (CHO) diets may promote increased LDL-c, TG, VLDL and HDL-c reduction, as well as PPL, generating a lipid profile associated with an increased risk of CVDs. This effect appears to be more pronounced with the inclusion of simple carbohydrates (mono and disaccharides), although it also occurs with diets rich in complex carbohydrates (polysaccharides). High fructose diets (HFDs) are a known model of induction of insulin resistance, dyslipidemia and DM2 in primates and humans. The chronic effect of fructose consumption has been well studied in the last decades due to its connection with obesity, resistance to Insulin, accumulation of visceral fat and dyslipidemia. As the consumption of fructose is progressively increasing in society and its chronic exposure can generate a phenotypic effect of dyslipidemia and, consequently, the increased risk of CVDs, prevention and treatment strategies should be seen as an important public health issue . Thus, the objective of this study is to understand the effects of exercise on fat metabolism, since there is a lack of robust evidence about the possible cardioprotective and hypolipemic role of the same on HFD.
    Detailed Description
    Background: Cardiovascular Diseases (CVDs) are the leading causes of death in the world and in Brazil. In 2001, 12.45 million deaths on the globe (21% of the total) were caused by some CVD. Different studies agree that CVDs can be prevented by reducing risk factors, such as: smoking, inadequate diet (high in fat, simple carbohydrates and salt), physical inactivity, obesity, diabetes mellitus (DM), high levels of Lipids in the blood (dyslipidemia) and hyperglycemia even in the absence of a diagnosis of DM. The composition of modern man's diet has changed drastically with the industrialization of food, resulting in the transition from a diet rich in fibers and complex carbohydrates to one with a high content of sugars and fats. Since the current dietary pattern is characterized by the consumption of three or more meals a day, containing a quantity of fat in the range of 20 to 70 g, individuals spend a large part of the day in the postprandial state, with continuous fluctuation of lipemia Over 18 hours. Food intake (postprandial state) is the dynamic, unstable response of the body that refers to rapid hormonal and lipoprotein remodeling. It is well established in the literature that high-fat meals (lipid overload) cause an increase in plasma triglycerides. Hypertriglyceridemia and / or elevated triglyceride-rich lipoproteins (LRT) (chylomicrons, VLDL and their remnants) in the postprandial state induces endothelial dysfunction via increased oxidative stress and is an independent risk factor for CVDs. Therefore, Postprandial Lipemia (PPL) is counted as an early marker of atherosclerotic process, metabolic abnormalities and endothelial dysfunction. High-carbohydrate (CHO) diets may promote increased LDL-c, TG, VLDL and HDL-c reduction, as well as PPL, generating a lipid profile associated with an increased risk of CVDs. This effect appears to be more pronounced with the inclusion of simple carbohydrates (mono and disaccharides), although it also occurs with diets rich in complex carbohydrates (polysaccharides). High fructose diets (HFDs) are a known model of induction of insulin resistance, dyslipidemia and DM2 in primates and humans. The chronic effect of fructose consumption has been well studied in the last decades due to its connection with obesity, resistance to Insulin, accumulation of visceral fat and dyslipidemia. Due to the increase in fructose consumption from beverages and processed foods, changes in lifestyle, mainly related to diet and exercise, should be seen as a means of prevention and first form of treatment of CVDs and changes in lipid metabolism. Acute and chronic aerobic exercise seems to reduce the risk of atherosclerosis and CVD by reducing lipemia (improvement of TG, CT, LDL-c and HDL-c) and endothelial function. In addition, the exercise when performed the previous day has the ability to prevent the increase of PPL after a hyperlipidic meal, regardless of body mass. This effect may be considered a cardiometabolic protection and seems to occur as a result of the increase in lipoprotein lipase (LPL) activity and / or reduction of VLDL secretion in the liver. As the consumption of fructose is progressively increasing in society and its chronic exposure can generate a phenotypic effect of dyslipidemia and, consequently, the increased risk of CVDs, prevention and treatment strategies should be seen as an important public health issue . Thus, the objective of this study is to understand the effects of exercise on fat metabolism, since there is a lack of robust evidence about the possible cardioprotective and hypolipemic role of the same on HFD. Methods: The study was characterized as a crossover randomized clinical trial, with a 7 day washout period. The sample was composed of 12 sedentary men, aged between 20 and 40 years. All volunteers who agreed to participate in the study signed a two-way informed consent form (TCLE). The study protocol followed the recommendations of the Helsinki Declaration. Subjects were invited to perform three (3) protocols, in a randomized fashion, with a minimum period of one week interval (washout period). On day 0, they arrived to the laboratory at the end of the day, between 6 and 7pm, to perform 45min of treadmill exercise at 60% of the VO2peak or rest, depending on randomization. Soon after, he received a Standard Meal (SM; 60% carbohydrate, 20% fat, 20% protein) in the laboratory and was instructed to perform a 12-hour fast. On day 1, they arrived at the laboratory between 7 and 8 a.m and were submitted to basal blood collection. Soon after, they received a High Fat Meal (HFM) which consisted of sandwich with cream and cheese, added to the drink rich in FRUCTose (0.5 g / kg) or DEXtrose (isoenergetic). The meals had the same energy and macronutrients (50% fat, 40% carbohydrate and 10% protein) and should be consumed in 10 minutes. Blood samples were collected from 1 to 4 h after the meal consumption to analyze the postprandial parameters. Subsequently the subject was released to perform his daily activities outside the laboratory. On the same day, between 6 pm and 7 pm, the subject returned to the laboratory to remain at rest and receive a SM again and be instructed to perform 12 hours of fasting. On day 2, subjects reached the laboratory between 7 and 8 a.m. and again submitted to baseline blood collection. Soon after, they received HFM with a drink rich in DEXtrose (0.5g / kg). Blood samples were collected from 1 to 4 hours after eating the meal. A 24h food record was done to control subject's diet. Body composition was evaluated before intervention. The data were analyzed using the statistical package IBM SPSS statistics (Statistical Package for Social Sciences) version 20.0 (IBM, USA) for Windows. The distribution of all variables was analyzed using the Shapiro-Wilk test, and the analysis sphericity by the Mauchly test. In cases where the data did not pass the normality tests, the respective nonparametric tests were performed. Data from the experimental groups were treated by two-way ANOVA for repeated measurements (2 x 5). If necessary, the Bonferroni post-hoc was used to identify differences. Incremental and total area under the curve were analyzed by trapezoidal method. The difference between AUC was verified by one-way ANOVA with post-hoc Bonferroni. All results were expressed as mean and standard deviation, or median, where appropriate, and the accepted level of significance was 5%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sedentary Lifestyle, Dyslipidemias, Lipid Metabolism Disorders, Carbohydrate Inducible Hyperlipemia
    Keywords
    fat metabolism, fructose, exercise

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FRUCTOSE
    Arm Type
    Experimental
    Arm Description
    Day 0, 45 min in rest position. Day 1, High Fat Meal (HFM) consisted of macronutrients (50% fat, 40% carbohydrate and 10% protein) with a fructose-rich beverage (0.5 g / kg). Day 2, High Fat Meal (HFM) consisted of macronutrients (50% fat, 40% carbohydrate and 10% protein) with a dextrose-rich beverage (0.5 g / kg).
    Arm Title
    DEXTROSE
    Arm Type
    Placebo Comparator
    Arm Description
    Day 0, 45 min in rest position. Day 1, High Fat Meal (HFM) consisted of macronutrients (50% fat, 40% carbohydrate and 10% protein) with a dextrose-rich beverage (0.5 g / kg). Day 2, High Fat Meal (HFM) consisted of macronutrients (50% fat, 40% carbohydrate and 10% protein) with a dextrose-rich beverage (0.5 g / kg).
    Arm Title
    FRUCTEX
    Arm Type
    Active Comparator
    Arm Description
    Day 0, 45 min of 60%VO2peak aerobic exercise . Day 1, High Fat Meal (HFM) consisted of macronutrients (50% fat, 40% carbohydrate and 10% protein) with a fructose-rich beverage (0.5 g / kg). Day 2, High Fat Meal (HFM) consisted of macronutrients (50% fat, 40% carbohydrate and 10% protein) with a dextrose-rich beverage (0.5 g / kg).
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    FRUCTOSE
    Other Intervention Name(s)
    High fat meal
    Intervention Description
    Fructose-rich beverage with a high fat meal, without exercise.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    DEXTROSE
    Other Intervention Name(s)
    High fat meal
    Intervention Description
    Dextrose-rich beverage with a high fat meal (control), without exercise.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    EXERCISE
    Intervention Description
    45 minutes of 60% VO2peak aerobic exercise
    Primary Outcome Measure Information:
    Title
    Triglycerides
    Description
    Parameter was analyzed by Cobas C111
    Time Frame
    4 hour postprandial test
    Title
    VLDL
    Description
    Parameter was analyzed by ELISA
    Time Frame
    4 hour postprandial test
    Secondary Outcome Measure Information:
    Title
    Glycemia
    Description
    Parameter was analyzed by Cobas C111
    Time Frame
    4 hour postprandial test
    Title
    Insulin
    Description
    Parameter was analyzed by Cobas C111
    Time Frame
    4 hour postprandial test
    Title
    HDL
    Description
    Parameter was analyzed by Cobas C111
    Time Frame
    4 hour postprandial test
    Title
    Non-HDL cholesterol
    Description
    Parameter was analyzed by formula
    Time Frame
    4 hour postprandial test

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: BMI (18,5 to 24,9 kg/m²) Sedentary lifestyle (< 150 minutes exercise per week) Fructose intake < 25g per day Otherwise healthy Exclusion Criteria: Smoker Drug user Using some medicine Fat metabolism disorders Orthopedic disorders

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of Exercise on Fructose-induced Postprandial Lipemia

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