NCT03173495

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

May 4, 2017

Last Update Submit

May 31, 2017

Conditions

Keywords

fat metabolismfructoseexercise

Outcome Measures

Primary Outcomes (2)

  • Triglycerides

    Parameter was analyzed by Cobas C111

    4 hour postprandial test

  • VLDL

    Parameter was analyzed by ELISA

    4 hour postprandial test

Secondary Outcomes (4)

  • Glycemia

    4 hour postprandial test

  • Insulin

    4 hour postprandial test

  • HDL

    4 hour postprandial test

  • Non-HDL cholesterol

    4 hour postprandial test

Study Arms (3)

FRUCTOSE

EXPERIMENTAL

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

DEXTROSE

PLACEBO COMPARATOR

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

FRUCTEX

ACTIVE COMPARATOR

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: FRUCTOSEDietary Supplement: EXERCISE

Interventions

FRUCTOSEDIETARY_SUPPLEMENT

Fructose-rich beverage with a high fat meal, without exercise.

Also known as: High fat meal
FRUCTEXFRUCTOSE
DEXTROSEDIETARY_SUPPLEMENT

Dextrose-rich beverage with a high fat meal (control), without exercise.

Also known as: High fat meal
DEXTROSE
EXERCISEDIETARY_SUPPLEMENT

45 minutes of 60% VO2peak aerobic exercise

FRUCTEX

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sedentary BehaviorDyslipidemiasLipid Metabolism DisordersHyperlipoproteinemia Type IVMotor Activity

Interventions

FructoseGlucoseExercise

Condition Hierarchy (Ancestors)

BehaviorMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasHypertriglyceridemia

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesKetosesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2017

First Posted

June 1, 2017

Study Start

January 10, 2016

Primary Completion

December 15, 2016

Study Completion

December 15, 2016

Last Updated

June 1, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share