CClinicalTrials.gg
Status unknownNCT03918005Updated Apr 17, 2019

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

An interventional study of Low glycemic load diet in Glycemic Index, Overweight and Obesity, sponsored by Instituto de Cardiologia do Rio Grande do Sul. Status unknown. Open to participants aged 20 Years to 59 Years. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by Instituto de Cardiologia do Rio Grande do Sul · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
20 Years to 59 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Glycemic Index
  • Overweight
  • Obesity
  • Pulse Wave Velocity

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03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's planned enrollment of 92 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul is the lead sponsor of 74 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
92 participants (estimated)

Study arms

  • Experimental
    Low glycemic load diet

    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

  • Active comparator
    High glycemic load diet

    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

  • OtherLow glycemic load diet

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

06

What researchers measure

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.

    Time frame: 6 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03918005
Lead sponsor
Instituto de Cardiologia do Rio Grande do Sul
Responsible party
Lisiane Perin (Principal Investigator, Instituto de Cardiologia do Rio Grande do Sul) — Principal investigator
First posted
Apr 17, 2019
Start date
Jun 1, 2019 (estimated)
Primary completion
Dec 31, 2020 (estimated)
Completion
Jul 31, 2021 (estimated)
Last update
Apr 17, 2019

Study contacts

Lisiane Perin, MsC
Contact
lisianeperin@hotmail.com
+5554999369888
Alexandre Lehnen, PhD
Contact
amlehnen@gmail.com
+555199768092
Lisiane Perin, MsC
principal investigator · Instituto de Cardiologia / Fundação Universitária de Cardiologia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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