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Beverage prepared with grape by-product: effect on oxidative stress and coronary artery disease markers in human beings

Effects of ingestion of a beverage prepared with grape by-product on plasma and low density lipoprotein (LDL) to oxidation and on antioxidant status in healthy individuals: a randomized, controlled, crossover clinical trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000824268
Enrollment
16
Registered
2009-09-22
Start date
2009-10-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study i to evaluate the effect of a beverage with the grape pomace flour from the grape juice and to evaluate its effect on oxidative stress and coronary artery disease marker in human beings. Sixteen healthy individuals will be enrolled in a randomized, controlled, crossover clinical trial to take the beverage made of the grape pomace flour (GPF) from the grape juice or commercial grape juice for two weeks. Blood samples of the individuals will be collected at baseline, after two weeks of intervention and the same protocol will be performed after fourteen days of washout. Triacylglycerols, total cholesterol and its fractions, C-reactive protein, IL-6 and TNF-a will be evaluated at the beginning and end of the experiment. Plasma and LDL will be submitted to the oxidation by Copper (Cu+2) at the four moments, followed by the measurement of the formed products of lipid peroxidation: the concentration of TBARs (Thiobarbituric acid-reactive substances) and the formation of conjugated dienes using spectrophotometric methods. The total antioxidant status of the plasma (TAS) and Oxygen Radical Absorbing Capacity will be likewise analyzed. Superoxide dismutase, catalase and glutathione peroxidase activities will be determined in erytrocitys. And analyzed DNA damage by comet Assay.

Interventions

Sixteen healthy individuals will be enrolled in a randomized, controlled, crossover clinical trial either to drink 300 mL of the beverage made with 4,8 % of the grape pomace flour (GPF) from the grape juice or commercial grape juice contents 1 % of grape pulp once daily for two weeks. After fourteen days of washout, the same individuals will drink the other beverage, commercial juice or from grape pomace, for more fourteen days. Blood samples of the individuals will be collected at baseline, aft

Sixteen healthy individuals will be enrolled in a randomized, controlled, crossover clinical trial either to drink 300 mL of the beverage made with 4,8 % of the grape pomace flour (GPF) from the grape juice or commercial grape juice contents 1 % of grape pulp once daily for two weeks. After fourteen days of washout, the same individuals will drink the other beverage, commercial juice or from grape pomace, for more fourteen days. Blood samples of the individuals will be collected at baseline, after two weeks of intervention and the same protocol will be performed after fourteen days of washout.

Sponsors

Marcela Piedade Monteiro
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

Body Mass Index (BMI): great than 19 kg/m2 and less than30 kg/m2,

Exclusion criteria

Pregnant, vegetarian diet, smoking, obesity, hypertension, use of supplements or drugs

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026