Nutritional Counseling Associated With the Ingestion of Oat Bran in

Status Completed

Clinical Trial Summary

Dyslipidemia is among the risk factors for cardiovascular diseases (CVD). Is's due to genetic and / or environmental factors such as inadequate dietary pattern. The occurrence of adverse events with statins, added to recent questions about their benefits on hard outcomes, opens a gap for the importance of seeking other forms of treatment of dyslipidemia, particularly in patients for secondary prevention. The consumption of oat bran, beta-glucan source of dietary fibers with supposed action in reducing the absorption of exogenous cholesterol and the endogenous synthesis of it, and source of avenanthramides, phytochemical compounds with alleged antioxidant in lipid membranes, can be effective strategy for secondary prevention of atherosclerotic disease.

Clinical Trial Description

Objectives: To evaluate the effect of nutritional counseling associated with the consumption of oat bran (40g per day) in lowering cholesterol, glucose profile and anthropometric parameters of subjects in secondary prevention, evaluate the quality of the diet and the intake of processed foods and ingredients added.

Methods: A randomized block, double-blind, placebo-controlled trial lasting 90 days. Inclusion criteria: individuals aged greater than 20 years, both genders, with LDL-c equal or higher than 130mg/dL fasting lipemia. Eligible individuals were considered using oral lipid-lowering, since the dose reported in the early nutritional intervention was maintained during the study. Exclusion criteria: patients requiring reduction in daily fluid intake, supplement use in dietary fiber and gestation / lactation. Data collected: gender; age; education; drugs; body mass (BM), height, body mass index (BMI), waist circumference (WC), neck circumference (NC); blood pressure; dietary surveys, total cholesterol (TC), LDL-C, HDL-cholesterol (HDL-c), triglycerides (TG), fasting glucose (GLU), fasting insulin (INS), HOMA-IR and QUICK. The diet quality was evaluated at baseline and end of study through the Diet Quality Index Revised (IQD-R). The sample size calculation was performed from a pilot study. It came to the need for 63 subjects for each group, oat bran group (GFAV) and placebo group (GPL). The level of statistical significance was 5% (p <0.05). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Dietary Modification

Clinical Trial Details

NCT number	NCT02189200
Study type	Interventional
Source	Universidade Federal do Rio de Janeiro
Contact
Status	Completed
Phase	N/A
Start date	October 2012
Completion date	April 2014

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03586622` - One Year Home Monitoring and Treatment of IBS Patients	N/A
Not yet recruiting	`NCT02858557` - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases	N/A
Completed	`NCT02589769` - Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons	N/A
Completed	`NCT03048487` - Protein Consumption in Critically Ill Patients
Withdrawn	`NCT02863822` - Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia.	N/A
Completed	`NCT03024983` - Pasta and Other Durum Wheat-based Products: Effects on Post-prandial Glucose Metabolism	N/A
Completed	`NCT02480504` - Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity	N/A
Recruiting	`NCT02848807` - Chemotherapy-related Toxicity, Nutritional Status and Quality of Life	N/A
Completed	`NCT02416284` - Compliance to the Norwegian Food-Based Dietary Guidelines in Young Females	N/A
Completed	`NCT01559896` - Egg Protein Hydrolysate and Vascular Function	N/A
Terminated	`NCT01329172` - Nasal Mucin Oral Supplementation Treatment Respiratory Inflammation Using PUFA in Cystic Fibrosis (CF) Patients	N/A
Completed	`NCT03698929` - Effect of Dietary Cholesterol on Plasma Lipids	N/A
Completed	`NCT03942822` - Chia Supplementation and Non Alcoholic Fatty Liver Disease	N/A
Completed	`NCT03319836` - Meeting Protein Targets in Critically Ill Patients
Completed	`NCT02940197` - Comparison of Two Calorie Restricted MediterrAsian Diet on Weight Loss in FTO rs9939609 Overweight Carriers	N/A
Completed	`NCT02811276` - The Impact of a High Protein Diet on Substrate Oxidation and Energy Metabolism	N/A
Completed	`NCT02582554` - Efficacy of Nutrition Risk Screening With NutriSTEP® in Toddlers and Preschoolers	N/A
Completed	`NCT02274220` - Feeding Study - Effects Post-cardiac Surgery	N/A
Completed	`NCT02574052` - Medical College Students' Responds to Menu Labeling	Phase 3
Completed	`NCT02898844` - Randomized Controlled Experiment of Dieting in Pairs	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms