Effects of Wine Grape Pomace Flour Used as a Dietary Supplement on Metabolic Syndrome Components
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|ClinicalTrials.gov Identifier: NCT02202863|
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : July 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome X Oxidative Stress||Dietary Supplement: Red wine grape pomace flour (WGPF)||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Start Date :||April 2013|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||September 2013|
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.
Dietary Supplement: Red wine grape pomace flour (WGPF)
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.
- Metabolic Syndrome [ Time Frame: Baseline and 16 weeks ]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
- 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®).
- Antioxidants [ Time Frame: Baseline and 16 weeks ]Antioxidants measurements: Total Plasma Antioxidant Capacity (TRAP), Total Plasma Antioxidant Reactivity (TAR), Vitamin C and Vitamin E.
- Oxidative stress [ Time Frame: Baseline and 16 weeks ]Oxitative stress markers: Malondialdehyde (MDA), Protein Carbonyl and the Methionine Sulfoxide in plasma.
- Inflammation [ Time Frame: Baseline and 16 weeks ]Inflammatory markers: Tumor Necrosis Factor -Alfa, IL-6, Monocyte Chemotactic Protein -1, in plasma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202863
|Centro de Nutricion Molecular y Enfermedades Cronicas, Pontificia Universidad Catolica de Chile|
|Santiago, Centro, Chile|
|Principal Investigator:||Ines Urquiaga, Ph.D||Centro de Nutricion y Enfermedades Cronicas, Pontificia Universidad Catolica de Chile|