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Completed

NCT Number: NCT03592511

Effect of the Consumption of Burgers Prepared With Wine Grape Pomace Flour, on Components of the Metabolic Syndrome

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)].

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Key information

Conditions

Food Selection Behavior Feeding Behavior Food Preferences Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

25 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WGPF-burger

Dietary Supplement

Volunteers consumed a WGPF-burger daily

Control-burger

Dietary Supplement

Volunteers consumed a Control-burger daily

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Insulin

    Time frame: Month 1, WFPG-burger consumption

    Fasting plasma Insulin was measured by electrochemiluminescence immunoassay (ECLIA; Roche Diagnostics®).

  2. Insulin

    Time frame: Month 3, control burger consumption

    Fasting plasma Insulin was measured by electrochemiluminescence immunoassay (ECLIA; Roche Diagnostics®).

  3. Antioxidants

    Time frame: Month 1, WFPG-burger consumption

    Antioxidants measurements: 2,2-diphenyl-1-picrylhydrazyl radical scavenging capacity (DPPH), uric acid, vitamin E, vitamin C

  4. Antioxidants

    Time frame: Month 3, control burger consumption

    Antioxidants measurements: 2,2-diphenyl-1-picrylhydrazyl radical scavenging capacity (DPPH), uric acid, vitamin E, vitamin C

  5. Oxidative stress

    Time frame: Month 1, WFPG-burger consumption

    Oxidative stress markers: Advanced oxidation protein products (AOPP), oxidized low-density lipoproteins (oxLDL), malondialdehyde (MDA)

  6. Oxidative stress

    Time frame: Month 3, control burger consumption

    Oxidative stress markers: Advanced oxidation protein products (AOPP), oxidized low-density lipoproteins (oxLDL), malondialdehyde (MDA)

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study 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

Acronym: WGPF-burger

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 19, 2018
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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