Effect of the Consumption of Burgers Prepared With Wine Grape Pomace Flour, on Components of the Metabolic Syndrome (WGPF-burger)
Primary Purpose
Food Selection, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
WGPF-burger
Control-burger
Sponsored by
About this trial
This is an interventional treatment trial for Food Selection focused on measuring Intervention study, Functional food, Grape pomace
Eligibility Criteria
Inclusion Criteria:
- The inclusion criteria were having at least one of the five components of metabolic syndrome and a BMI between 25.0 and 39.9 kg/m2
Exclusion Criteria:
- Exclusion criteria were use of drug therapy for diabetes mellitus, hypertension, or dyslipidemia and intake of pharmacological treatment with drugs that modify plasma antioxidant capacity or inflammation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
WGPF-burger group
Control-burger group
Outcomes
Primary Outcome Measures
Metabolic syndrome components
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
Metabolic syndrome components
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
Secondary Outcome Measures
Insulin
Fasting plasma Insulin was measured by electrochemiluminescence immunoassay (ECLIA; Roche Diagnostics®).
Insulin
Fasting plasma Insulin was measured by electrochemiluminescence immunoassay (ECLIA; Roche Diagnostics®).
Antioxidants
Antioxidants measurements: 2,2-diphenyl-1-picrylhydrazyl radical scavenging capacity (DPPH), uric acid, vitamin E, vitamin C
Antioxidants
Antioxidants measurements: 2,2-diphenyl-1-picrylhydrazyl radical scavenging capacity (DPPH), uric acid, vitamin E, vitamin C
Oxidative stress
Oxidative stress markers: Advanced oxidation protein products (AOPP), oxidized low-density lipoproteins (oxLDL), malondialdehyde (MDA)
Oxidative stress
Oxidative stress markers: Advanced oxidation protein products (AOPP), oxidized low-density lipoproteins (oxLDL), malondialdehyde (MDA)
Full Information
NCT ID
NCT03592511
First Posted
June 21, 2018
Last Updated
July 17, 2018
Sponsor
Pontificia Universidad Catolica de Chile
1. Study Identification
Unique Protocol Identification Number
NCT03592511
Brief Title
Effect of the Consumption of Burgers Prepared With Wine Grape Pomace Flour, on Components of the Metabolic Syndrome
Acronym
WGPF-burger
Official Title
Effect of the Consumption of Burgers Prepared With Wine Grape Pomace Flour, Rich in Fiber and Antioxidants, on Components of the Metabolic Syndrome in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 15, 2016 (Actual)
Primary Completion Date
October 15, 2016 (Actual)
Study Completion Date
October 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pontificia Universidad Catolica de Chile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Wine grape pomace flour (WGPF) is a fruit byproduct high in fiber and antioxidants. The effect of WGPF consumption was tested on blood biochemical parameters including oxidative stress biomarkers. In a 3-month intervention study, 27 male volunteers, each with some components of metabolic syndrome, consumed a beef burger supplemented with 7% WGPF containing 3.5% of fiber and 1.2 mg GE/g of polyphenols (WGPF-burger), daily during the first month. The volunteers consumed no burgers in the second month, and one control burger daily in the third month. At baseline and after these periods, there were evaluated metabolic syndrome components, plasma antioxidant status [2,2-diphenyl-1-picrylhydrazyl radical scavenging capacity (DPPH),uric acid, vitamin E, vitamin C], and oxidative damage markers [advanced oxidation protein products (AOPP), oxidized low-density lipoproteins (oxLDL), malondialdehyde (MDA)].
Detailed Description
The intervention was carried out at workplaces in Santiago, Chile. Workers were informed about the study and invited to participate. Initially, 34 male workers meeting all criteria agreed to partake, however 27 workers completed the study. Seven volunteers quit the study because three disliked the blood sampling procedure, two were sent to work abroad, one left the workplace, and one presented gastrointestinal symptoms associated with WGPF-burger consumption.
The volunteers entered a longitudinal trial consisting of two treatment periods of 4 weeks, separated by a third four-week wash-out period. For the first 4 weeks, they consumed one WGPF-burger daily, then they were washed-out and finally they consumed one control-burger daily during 4 weeks. They were asked to maintain their regular eating habits and lifestyle during the study, except for the daily intake of burgers during the treatment periods. The burgers were eaten in replacement of red or processed meat consumption, or in addition to their regular meal when it did not contain meat products. During the washout period, all subjects consumed their usual diet. Burger intake was supervised every day at lunch at the canteens of the workplaces. On weekends, participants were asked to consume burgers at home with their regular meals. In addition, compliance with burger consumption was carefully monitored by frequent calls from the dietitian.
Blood samples were obtained at weeks 0, 4, 8, and 12 for analysis. Participants had clinical, nutritional, and anthropometric evaluations at the beginning and the end of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Selection, Metabolic Syndrome
Keywords
Intervention study, Functional food, Grape pomace
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
WGPF-burger group
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control-burger group
Intervention Type
Dietary Supplement
Intervention Name(s)
WGPF-burger
Intervention Description
Volunteers consumed a WGPF-burger daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Control-burger
Intervention Description
Volunteers consumed a Control-burger daily
Primary Outcome Measure Information:
Title
Metabolic syndrome components
Description
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
Time Frame
Month 1, WFPG-burger consumption
Title
Metabolic syndrome components
Description
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
Time Frame
Month 3, control burger consumption
Secondary Outcome Measure Information:
Title
Insulin
Description
Fasting plasma Insulin was measured by electrochemiluminescence immunoassay (ECLIA; Roche Diagnostics®).
Time Frame
Month 1, WFPG-burger consumption
Title
Insulin
Description
Fasting plasma Insulin was measured by electrochemiluminescence immunoassay (ECLIA; Roche Diagnostics®).
Time Frame
Month 3, control burger consumption
Title
Antioxidants
Description
Antioxidants measurements: 2,2-diphenyl-1-picrylhydrazyl radical scavenging capacity (DPPH), uric acid, vitamin E, vitamin C
Time Frame
Month 1, WFPG-burger consumption
Title
Antioxidants
Description
Antioxidants measurements: 2,2-diphenyl-1-picrylhydrazyl radical scavenging capacity (DPPH), uric acid, vitamin E, vitamin C
Time Frame
Month 3, control burger consumption
Title
Oxidative stress
Description
Oxidative stress markers: Advanced oxidation protein products (AOPP), oxidized low-density lipoproteins (oxLDL), malondialdehyde (MDA)
Time Frame
Month 1, WFPG-burger consumption
Title
Oxidative stress
Description
Oxidative stress markers: Advanced oxidation protein products (AOPP), oxidized low-density lipoproteins (oxLDL), malondialdehyde (MDA)
Time Frame
Month 3, control burger consumption
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria were having at least one of the five components of metabolic syndrome and a BMI between 25.0 and 39.9 kg/m2
Exclusion Criteria:
Exclusion criteria were use of drug therapy for diabetes mellitus, hypertension, or dyslipidemia and intake of pharmacological treatment with drugs that modify plasma antioxidant capacity or inflammation.
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of the Consumption of Burgers Prepared With Wine Grape Pomace Flour, on Components of the Metabolic Syndrome
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