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

NCT03918005 | Unknown

• 1 other identifier: lisianeperin@hotmail.com
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glycemic Index; Overweight; Obesity; Pulse Wave Velocity

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Study Arms (2)

Low glycemic load diet

EXPERIMENTAL

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

Other: Low glycemic load diet

High glycemic load diet

ACTIVE COMPARATOR

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

Other: Low glycemic load diet

Interventions

Low glycemic load diet OTHER

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

High glycemic load diet; Low glycemic load diet

Eligibility Criteria

• Age: 20 Years - 59 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisiane Perin, MsC

  Instituto de Cardiologia / Fundação Universitária de Cardiologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisiane Perin, MsC

CONTACT

+5554999369888; lisianeperin@hotmail.com

Alexandre Lehnen, PhD

CONTACT

+555199768092; amlehnen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 17, 2019
• Study Start: June 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: July 31, 2021
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share