- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02202863
Effects of Wine Grape Pomace Flour Used as a Dietary Supplement on Metabolic Syndrome Components
Study on the Effects of Wine Grape Pomace Flour, Used as a Dietary Supplement to Increase the Intake of Dietary Fiber and Antioxidants in Human, on Components of Metabolic Syndrome, Plasma Antioxidants, Oxidative Stress Markers and Inflammatory Markers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A 16-week longitudinal intervention study. Males, 30-65 years of age, with at least one component of metabolic syndrome, were randomly assigned to either the intervention group or the control group. At lunch, the intervention group was given 20 g of WGPF per day, which contained 10 g of dietary fiber and an antioxidant capacity of 7,258 ORAC (oxygen radical absorbance capacity) units. Both groups were asked to maintain their regular eating habits and lifestyles. Clinical evaluation, anthropometric measurements and biochemical blood analyses were done at the beginning and the end of the study.
The intervention was carried out at a heavy mining machinery company in Santiago, Chile. All employees were informed about the study and invited to participate. Initially, 47 male workers free of exclusion criteria agreed to participate. The number of participants in each group was chosen based on the variation coefficients in the evolution of total cholesterol in the intervention and in the control group, observed in a previous work (Jiménez, J.P., et al., Effects of grape antioxidant dietary fiber in cardiovascular disease risk factors. Nutrition, 2008. 24(7-8): 646-53).
Statistical analysis: Continuous variables will be shown as mean and standard deviation, while categorical variables as the number of cases and percentage. The student t-test for independent samples and the chi-square test will be used to analyze differences of means and proportions between the two groups, respectively. The student t-test for paired samples and McNemar's test will be used to analyze differences of means and proportions within each group. When appropriate, the Wilcoxon signed rank-sum test will be used to compare paired medians. All p values will be two-tailed and a value <0.05 will be considered to be statistically significant. Data processing and statistical analyses will be done with the SAS statistical software package version 9.1 for Windows.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Centro
-
Santiago, Centro, Chile
- Centro de Nutricion Molecular y Enfermedades Cronicas, Pontificia Universidad Catolica de Chile
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject who regularly consumed an omnivorous diet.
- Subjects that had at least one of the five components of metabolic syndrome.
Exclusion Criteria:
- Subjects that were under treatment for diabetes mellitus, hypertension (> 160/100) or dyslipidemia (hypertriglyceridemia> 500 mg / dl, hypercholesterolemia> 350 mg / dl)
- Subjects who consume drugs affecting lipid profile, blood pressure, metabolism of carbohydrates or the antioxidant capacity of plasma.
- Subjects with obesity, BMI > 30
- Subjects who have had a cardiovascular event.
- Subjects with bariatric surgery
- Subjects with untreated thyroid disease, renal disease (serum creatinine> 1.5 mg / dl), active liver disease, or other rheumatic disease that could alter the measurements.
- Subjects with chronic inflammatory diseases.
- Subjects that use of supplements containing antioxidants.
- Smoking more than 5 cigarettes per day
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Red Wine Grape Pomace Flour (WGPF)
Subjects were asked to maintain their regular eating habits and lifestyles for 16 weeks, except for the daily intake of 20 g of WGPF.
WGPF was consumed in bread, biscuits or as flour mixed with water during lunch.
Bread and biscuits with 20% WGPF were prepared especially in a bakery.
WGPF intake was supervised every day at lunch.
Participants were asked to consume the flour supplement with their regular meals on weekends.
|
Pomace, a byproduct from wine production, was obtained from red wine grapes, Cabernet Sauvignon, vintage 2011, Maipo Valley, Chile, after alcoholic fermentation.
The wine grape pomace was dried and grounded to obtain the flour.
Intervention group ate 20 g per day of this flour, which contained 10 g of dietary fiber and an antioxidant capacity of 7,258 ORAC units.
|
No Intervention: Control
Subjects were asked to maintain their regular eating habits and lifestyles for 16 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic Syndrome
Time Frame: Baseline and 16 weeks
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The presence of metabolic syndrome components was defined using the criteria proposed by the Adult Treatment Panel III of the US National Cholesterol Education Program: (i) abdominal obesity as waist circumference >102 cm for men; (ii) low levels (<40 mg/dL for men) of serum high density lipoprotein cholesterol; (iii) hypertriglyceridemia as 150 mg/dL or more; (iv) elevated blood pressure as 130/85 mm Hg or higher; and (v) impaired glucose homeostasis as fasting plasma glucose levels of 100 mg/dL or higher
|
Baseline and 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial insulin
Time Frame: Baseline and 16 weeks
|
An oral glucose tolerance test (OGTT) was performed after overnight fasting.
Subjects ingested a solution containing 75 g of dextrose, and venous blood samples were obtained at 0 and 120 min to determine plasma glucose and insulin levels.
Insulin was measured by electrochemiluminescence immunoassay (ECLIA; Roche Diagnostics®).
|
Baseline and 16 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antioxidants
Time Frame: Baseline and 16 weeks
|
Antioxidants measurements: Total Plasma Antioxidant Capacity (TRAP), Total Plasma Antioxidant Reactivity (TAR), Vitamin C and Vitamin E.
|
Baseline and 16 weeks
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Oxidative stress
Time Frame: Baseline and 16 weeks
|
Oxitative stress markers: Malondialdehyde (MDA), Protein Carbonyl and the Methionine Sulfoxide in plasma.
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Baseline and 16 weeks
|
Inflammation
Time Frame: Baseline and 16 weeks
|
Inflammatory markers: Tumor Necrosis Factor -Alfa, IL-6, Monocyte Chemotactic Protein -1, in plasma
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Baseline and 16 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ines Urquiaga, Ph.D, Centro de Nutricion y Enfermedades Cronicas, Pontificia Universidad Catolica de Chile
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-029
- FONDEF AF10 I1014 (Other Identifier: CONICYT CHILE)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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