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
About this trial
This is an interventional treatment trial for Glycemic Index
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)
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
NCT ID
NCT03918005
First Posted
April 2, 2019
Last Updated
April 15, 2019
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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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Effects of Hypocaloric Diets With Different Glycemic Loads on Pulse Wave Velocity
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