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Effects of Hypocaloric Diets With Different Glycemic Loads on Pulse Wave Velocity

Primary Purpose

Glycemic Index, Overweight, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low glycemic load diet
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glycemic Index

Eligibility Criteria

20 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both sex
  • Between 20 and 59 years old
  • Body mass index ≥ 25.0 kg/m²
  • Physically inactive (physical activity <150 min/week)

Exclusion Criteria:

  • Pregnant women
  • Vegetarians
  • Vegans
  • Users of dietary supplements
  • Smokers
  • Alcohol abusers (men: more than 4 doses in a single day or more than 14 doses per week; women: more than 3 doses in a single day or more than 7 doses per week)
  • Individuals with a previous diagnosis of hypertension
  • Chronic kidney disease
  • Type 1 or 2 diabetes mellitus
  • Hypothyroidism
  • Hyperthyroidism
  • Events in the last 6 months (coronary artery disease, acute myocardial infarction, cerebral vascular disease, peripheral arterial disease, or heart failure)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Low glycemic load diet

    High glycemic load diet

    Arm Description

    Foods with low glycemic index or glycemic load (brown rice, brown bread, whole wheat pasta, oat bran, yogurt, milk, apple, pear, peach)

    Foods with high glycemic index or glycemic load (white rice, white bread, corn flakes, mashed potatoes, orange juice, banana, persimmon, grape, raisins, honey, sugar)

    Outcomes

    Primary Outcome Measures

    Pulse wave velocity
    The calibrated and validated Mobil-O-Graph® portable monitor (IEM GmbH, Stolberg, Germany) will be used. This module is connected to a computer to record the brachial pulse wave. It performs pulse wave analysis based on the oscillometric method. The arterial pulsation generates pressure oscillations, which are transmitted to the blood pressure cuff and measured by the transducer to be interpreted by a specific software, recording the pulse wave of the brachial artery and deriving a pulse wave from the aortic arch. All measurements will be performed by the same evaluator on the right side of the volunteer, at rest. Subjects will be instructed to be with empty bladder, not to drink coffee 60 minutes before gauging and alcoholic beverage in the last 24 hours. The pulse wave velocity will be evaluated before the beginning of the diets and 6 weeks after the beginning of the diets.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 2, 2019
    Last Updated
    April 15, 2019
    Sponsor
    Instituto de Cardiologia do Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03918005
    Brief Title
    Effects of Hypocaloric Diets With Different Glycemic Loads on Pulse Wave Velocity
    Official Title
    Effects of Hypocaloric Diets With Different Glycemic Loads on Pulse Wave Velocity in Overweight and Obese Adults: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2019 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    July 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto de Cardiologia do Rio Grande do Sul

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Worldwide, in terms of attributable deaths, the main intermediate risk factor for the development of cardiovascular diseases is systemic arterial hypertension, followed by overweight and sustained hyperglycemia. These factors have positively influenced public and private spending on health. The more robust studies showed that age is one of the main determinants of arterial stiffness. However, there is a possibility that other variables, such as elevated glucose levels, obesity, and systemic inflammation itself, as well as insulin resistance are important factors in this scenario. On the other hand, the measurement of the pulse wave velocity is widely acceptable for the evaluation of the arterial stiffness, inferring the cardiovascular risk in different populations. Since arterial stiffness is influenced by hemodynamic forces and inflammatory mediators, which may be related to sodium and glucose balance, it is necessary to evaluate whether a hypocaloric and low glycemic load diet, in a thesis that decreases lipid and inflammatory levels, may have favorable effects on pulse wave velocity in overweight adults.
    Detailed Description
    The diets will be calculated in Microsoft Excel 2018 software, using tables of nutritional composition, glycemic index and glycemic load, which have foods with high glycemic index or glycemic load (white rice, white bread, corn flakes, mashed potatoes, orange juice (brown rice, whole wheat bread, whole noodles, oat bran, yogurt, milk, apple, pear, peach). The methodology for calculating GC estimates will be based on the FAO / WHO Protocol. The diets will be designed in 1200, 1400, 1600, 1800 and 2000 kcal / day. All participants will be categorized according to one of the five levels of the diet's energy content. In addition, all patients will receive a leaflet with nutritional guidelines according to their diet. During the study, participants will be required to maintain their medication consumption, if any, as prescribed by a physician. To assess adherence to the diet, participants will consult with a nutritionist on a weekly basis and complete the 24-hour food recall. It will be measured the pulse wave velocity.This outcome will be evaluated before the beginning of the diets and 6 weeks after the beginning of the diets.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glycemic Index, Overweight, Obesity, Pulse Wave Velocity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    92 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Low glycemic load diet
    Arm Type
    Experimental
    Arm Description
    Foods with low glycemic index or glycemic load (brown rice, brown bread, whole wheat pasta, oat bran, yogurt, milk, apple, pear, peach)
    Arm Title
    High glycemic load diet
    Arm Type
    Active Comparator
    Arm Description
    Foods with high glycemic index or glycemic load (white rice, white bread, corn flakes, mashed potatoes, orange juice, banana, persimmon, grape, raisins, honey, sugar)
    Intervention Type
    Other
    Intervention Name(s)
    Low glycemic load diet
    Intervention Description
    Foods with low glycemic index or glycemic load (brown rice, brown bread, whole wheat pasta, oat bran, yogurt, milk, apple, pear, peach)
    Primary Outcome Measure Information:
    Title
    Pulse wave velocity
    Description
    The calibrated and validated Mobil-O-Graph® portable monitor (IEM GmbH, Stolberg, Germany) will be used. This module is connected to a computer to record the brachial pulse wave. It performs pulse wave analysis based on the oscillometric method. The arterial pulsation generates pressure oscillations, which are transmitted to the blood pressure cuff and measured by the transducer to be interpreted by a specific software, recording the pulse wave of the brachial artery and deriving a pulse wave from the aortic arch. All measurements will be performed by the same evaluator on the right side of the volunteer, at rest. Subjects will be instructed to be with empty bladder, not to drink coffee 60 minutes before gauging and alcoholic beverage in the last 24 hours. The pulse wave velocity will be evaluated before the beginning of the diets and 6 weeks after the beginning of the diets.
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Both sex Between 20 and 59 years old Body mass index ≥ 25.0 kg/m² Physically inactive (physical activity <150 min/week) Exclusion Criteria: Pregnant women Vegetarians Vegans Users of dietary supplements Smokers Alcohol abusers (men: more than 4 doses in a single day or more than 14 doses per week; women: more than 3 doses in a single day or more than 7 doses per week) Individuals with a previous diagnosis of hypertension Chronic kidney disease Type 1 or 2 diabetes mellitus Hypothyroidism Hyperthyroidism Events in the last 6 months (coronary artery disease, acute myocardial infarction, cerebral vascular disease, peripheral arterial disease, or heart failure)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lisiane Perin, MsC
    Phone
    +5554999369888
    Email
    lisianeperin@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexandre Lehnen, PhD
    Phone
    +555199768092
    Email
    amlehnen@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lisiane Perin, MsC
    Organizational Affiliation
    Instituto de Cardiologia / Fundação Universitária de Cardiologia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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