Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Exercise on Fructose-induced Postprandial Lipemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03173495
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul

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.


Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Dyslipidemias Lipid Metabolism Disorders Carbohydrate Inducible Hyperlipemia Dietary Supplement: FRUCTOSE Dietary Supplement: DEXTROSE Dietary Supplement: EXERCISE Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Exercise on Fructose-induced Postprandial Lipemia
Actual Study Start Date : January 10, 2016
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : December 15, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FRUCTOSE
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).
Dietary Supplement: FRUCTOSE
Fructose-rich beverage with a high fat meal, without exercise.
Other Name: High fat meal

Placebo Comparator: DEXTROSE
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).
Dietary Supplement: DEXTROSE
Dextrose-rich beverage with a high fat meal (control), without exercise.
Other Name: High fat meal

Active Comparator: FRUCTEX
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).
Dietary Supplement: FRUCTOSE
Fructose-rich beverage with a high fat meal, without exercise.
Other Name: High fat meal

Dietary Supplement: EXERCISE
45 minutes of 60% VO2peak aerobic exercise




Primary Outcome Measures :
  1. Triglycerides [ Time Frame: 4 hour postprandial test ]
    Parameter was analyzed by Cobas C111

  2. VLDL [ Time Frame: 4 hour postprandial test ]
    Parameter was analyzed by ELISA


Secondary Outcome Measures :
  1. Glycemia [ Time Frame: 4 hour postprandial test ]
    Parameter was analyzed by Cobas C111

  2. Insulin [ Time Frame: 4 hour postprandial test ]
    Parameter was analyzed by Cobas C111

  3. HDL [ Time Frame: 4 hour postprandial test ]
    Parameter was analyzed by Cobas C111

  4. Non-HDL cholesterol [ Time Frame: 4 hour postprandial test ]
    Parameter was analyzed by formula



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Layout table for additonal information
Responsible Party: Alvaro Reischak-Oliveira, Principal Investigator, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT03173495     History of Changes
Other Study ID Numbers: 48763715.3.0000.5347
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul:
fat metabolism
fructose
exercise
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperlipoproteinemia Type IV
Dyslipidemias
Metabolic Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Hypertriglyceridemia