Food SelectionWGPF-burgerNCT03592511
Effect of the Consumption of Burgers Prepared With Wine Grape Pomace Flour, on Components of the Metabolic Syndrome
A study testing WGPF-burger in people with Food Selection and Metabolic Syndrome, run by Pontificia Universidad Catolica de Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Food Selection, Metabolic Syndrome
- What is being tested?
- WGPF-burger
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2016to 15 Oct 2016
- 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 25 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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
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)].
Read the 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.
- Conditions
- Food Selection, Metabolic Syndrome
- Being tested
- WGPF-burger, Control-burger
- Keywords
- Intervention study, Functional food, Grape pomace
- Medical subject headings
- Food Preferences, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WGPF-burgerDietary supplement
Volunteers consumed a WGPF-burger daily
Control-burgerDietary supplement
Volunteers consumed a Control-burger daily
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | WGPF-burger group Receives: Dietary Supplement: WGPF-burger; Dietary Supplement: Control-burger |
| Control | Placebo comparator | Control-burger group Receives: Dietary Supplement: Control-burger |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 1, WFPG-burger consumption
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
Measured: Month 3, control burger consumption
Secondary outcomes (6)
Insulin
Fasting plasma Insulin was measured by electrochemiluminescence immunoassay (ECLIA; Roche Diagnostics®).
Measured: Month 1, WFPG-burger consumption
Insulin
Fasting plasma Insulin was measured by electrochemiluminescence immunoassay (ECLIA; Roche Diagnostics®).
Measured: Month 3, control burger consumption
Antioxidants
Antioxidants measurements: 2,2-diphenyl-1-picrylhydrazyl radical scavenging capacity (DPPH), uric acid, vitamin E, vitamin C
Measured: Month 1, WFPG-burger consumption
Antioxidants
Antioxidants measurements: 2,2-diphenyl-1-picrylhydrazyl radical scavenging capacity (DPPH), uric acid, vitamin E, vitamin C
Measured: Month 3, control burger consumption
Oxidative stress
Oxidative stress markers: Advanced oxidation protein products (AOPP), oxidized low-density lipoproteins (oxLDL), malondialdehyde (MDA)
Measured: Month 1, WFPG-burger consumption
Oxidative stress
Oxidative stress markers: Advanced oxidation protein products (AOPP), oxidized low-density lipoproteins (oxLDL), malondialdehyde (MDA)
Measured: Month 3, control burger consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start15 Jun 2016
- Primary completion15 Oct 2016
- Study completion15 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SelectionStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inés Urquiaga, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592511
- Sponsor's protocol ID
- 15-122
- Other IDs
- IT14I10011
- Acronym
- WGPF-burger
- Status last verified
- Jul 2018
- First submitted
- 21 Jun 2018
- Last updated
- 19 Jul 2018
- 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 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03592511
- Acronym / sponsor ID
- WGPF-burger / 15-122
- Conditions
- Food Selection, Metabolic Syndrome
- Keywords
- Intervention study, Functional food, Grape pomace
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 15 Oct 2016 (actual)
- Study completion
- 15 Oct 2016 (actual)
- First posted
- 19 Jul 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: WGPF-burger, Dietary Supplement: Control-burgerWGPF-burger group |
| Control | Placebo comparator | Dietary Supplement: Control-burgerControl-burger group |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| WGPF-burgerVolunteers consumed a WGPF-burger daily | Dietary supplement | Intervention |
| Control-burgerVolunteers consumed a Control-burger daily | Dietary supplement | Control, Intervention |
Primary outcome
Metabolic syndrome components
Time frame: Month 1, WFPG-burger consumption
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
Time frame: Month 3, control burger consumption
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
6 secondary outcomes
Insulin
Time frame: Month 1, WFPG-burger consumption
Insulin
Time frame: Month 3, control burger consumption
Antioxidants
Time frame: Month 1, WFPG-burger consumption
Antioxidants
Time frame: Month 3, control burger consumption
Oxidative stress
Time frame: Month 1, WFPG-burger consumption
Oxidative stress
Time frame: Month 3, control burger consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing WGPF-burger in people with Food Selection and Metabolic Syndrome, run by Pontificia Universidad Catolica de Chile.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Jul 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic syndrome components (time frame: Month 1, WFPG-burger consumption). The study lists 2 primary outcomes in all. 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 19 Jul 2018.