Ignite Creation Date:
2024-05-06 @ 2:26 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02047123
Status:
COMPLETED
Last Update Posted:
2014-07-22
First Post:
2014-01-24
Brief Title:
Nutritional Intervention With Yogurt and Flaxseed in Women With Profiles Lipi
Sponsor:
Universidad Miguel Hernandez de Elche
Organization:
Universidad Miguel Hernandez de Elche
Study Overview
Official Title:
Nutritional Intervention With Yogurt and Flaxseed in Women With Profiles Lipidic to the Limit A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
flaxseed
Brief Summary:
Flax Linum usitatissimum L is an economically important oilseed Lifestyle and diet are the first line interventions to reduce the short-term and long-term cardiovascular risk factors Due to its high content of lignans α-linolenic acid LNA and fiber flaxseed has a beneficial effect on CVD risk factors components to decrease the risk of cardiovascular disease Objective To determine the effect of the consumption of flax seed yogurt on the women lipid profile values to the limit users of a pharmacy in Elche and in this way reduce the small dyslipidemia The investigators performed an intervention including 133 women age 25-70 years Participants were randomly and double-blind distributed into three groups Group 1 n 30 consumed flaxseed FS yoghurt Y and diet D Group 2 n 32 volunteers consumed Y D and Group 3 n27 consumed only diet All groups followed a limit levels-cholesterol diet Circulating total cholesterol HDL-cholesterol LDL-cholesterol and triglycerides and were determined at the beginning and end of a 30-day test As a result group 1 presented significantly reduced total cholesterol levels Correlation analysis indicated that the intake of FS could explain the flaxseed effect of the variation of the cholesterol and TG in this group Altogether this study concludes that consumption FS exert a positive impact in total cholesterol level and TG
Detailed Description:
It is an analytical intervention study using a random single blind controlled type trial conducted at a pharmacy in Elche on female clients with mild alterations in their lipid profile Since they were patients with a high cardiovascular risk the investigators aimed to determine the effect of the administration of FSYD YD and D on various nutritional indicators
A monitoring of nutritional intervention was carried out for 30 days and blood samples were obtained by capillary puncture for total cholesterol levels triglycerides glucose These parameters were determined in situ by dry chemistry A series of anthropometric measures were also carried out at the beginning and at the end of the study including weight and height BMI Body Mass Index WHR waist-hip ratio systolic and diastolic arterial pressure and heart rate
Statistical analysis was carried out using STATGRAPHICS Centurion XV software StatPoint Technologies Inc Warrington VA USA likewise significance was defined at p 005 Data are reported as mean standard error of the mean sem Intra-group statistical comparisons were performed using the following hypothesis tests both parametric and non-parametric t-test sign test and signed rank test for paired samples Inter-group statistical comparisons were performed using the one-way analysis of variance and the Kruskal-Wallis hypothesis tests Also Fishers least significant difference LSD Multiple Range Test and Tukeys honestly significant difference HSD were used in order to determine which means were significantly different from the others In addition Generalized Multiple Regression was used to statistically analyze the relationships between the variations in the lipid profile and the different factors included in the study
A monitoring of nutritional intervention was carried out for 30 days and blood samples were obtained by capillary puncture for total cholesterol levels triglycerides glucose These parameters were determined in situ by dry chemistry A series of anthropometric measures were also carried out at the beginning and at the end of the study including weight and height BMI Body Mass Index WHR waist-hip ratio systolic and diastolic arterial pressure and heart rate
Statistical analysis was carried out using STATGRAPHICS Centurion XV software StatPoint Technologies Inc Warrington VA USA likewise significance was defined at p 005 Data are reported as mean standard error of the mean sem Intra-group statistical comparisons were performed using the following hypothesis tests both parametric and non-parametric t-test sign test and signed rank test for paired samples Inter-group statistical comparisons were performed using the one-way analysis of variance and the Kruskal-Wallis hypothesis tests Also Fishers least significant difference LSD Multiple Range Test and Tukeys honestly significant difference HSD were used in order to determine which means were significantly different from the others In addition Generalized Multiple Regression was used to statistically analyze the relationships between the variations in the lipid profile and the different factors included in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Enrique Roche Collado | OTHER_GRANT | Instituto de Salud Carlos III-FEDER PS0901093 | None |