Glycemic IndexNCT03918005
Effects of Hypocaloric Diets With Different Glycemic Loads on Pulse Wave Velocity
A study testing Low glycemic load diet in people with Glycemic Index and Overweight, run by Instituto de Cardiologia do Rio Grande do Sul.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Glycemic Index, Overweight, Obesity
- What is being tested?
- Low glycemic load diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both sex
- Between 20 and 59 years old
- Body mass index ≥ 25.0 kg/m²
- Physically inactive (physical activity <150 min/week)
Who cannot join
- 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)
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- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Hypocaloric Diets With Different Glycemic Loads on Pulse Wave Velocity in Overweight and Obese Adults: a Randomized Clinical Trial
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.
- Conditions
- Glycemic Index, Overweight, Obesity, Pulse Wave Velocity
- Being tested
- Low glycemic load diet
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic load dietOther
Foods with low glycemic index or glycemic load (brown rice, brown bread, whole wheat pasta, oat bran, yogurt, milk, apple, pear, peach)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Low glycemic load diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start1 Jun 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic IndexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisiane Perin, Instituto de Cardiologia do Rio Grande do Sul
- Investigators
- Lisiane Perin, MsC, Principal investigator, Instituto de Cardiologia / Fundação Universitária de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918005
- Sponsor's protocol ID
- lisianeperin@hotmail.com
- Status last verified
- Apr 2019
- First submitted
- 2 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hypocaloric Diets With Different Glycemic Loads on Pulse Wave Velocity in Overweight and Obese Adults: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03918005
- Acronym / sponsor ID
- lisianeperin@hotmail.com
- Conditions
- Glycemic Index, Overweight, Obesity, Pulse Wave Velocity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low glycemic load diet | Experimental | Other: Low glycemic load dietFoods 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 | Active comparator | Other: Low glycemic load dietFoods with high glycemic index or glycemic load (white rice, white bread, corn flakes, mashed potatoes, orange juice, banana, persimmon, grape, raisins, honey, sugar) |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both sex
- Between 20 and 59 years old
- Body mass index ≥ 25.0 kg/m²
- Physically inactive (physical activity <150 min/week)
Key exclusion criteria (12 listed)
- Pregnant women
- Vegetarians
- Vegans
- Users of dietary supplements
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low glycemic load dietFoods with low glycemic index or glycemic load (brown rice, brown bread, whole wheat pasta, oat bran, yogurt, milk, apple, pear, peach) | Other | High glycemic load diet, Low glycemic load diet |
Primary outcome
Pulse wave velocity
Time frame: 6 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisiane Perin, MsC principal investigator
Instituto de Cardiologia / Fundação Universitária de Cardiologia
Questions about this trial
What is this clinical trial studying?
A study testing Low glycemic load diet in people with Glycemic Index and Overweight, run by Instituto de Cardiologia do Rio Grande do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisiane Perin, MsC (+5554999369888, lisianeperin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.