The Effect Of Low-Fat And Low-Cholesterol Dietary Intervention On LDL Sub-Groups In Turkısh Dyslipidemic Patients

Dyslipidemias Clinical Trial

Official title:

The Short Term Beneficıal Effects Of A Low-Fat And Low-Cholesterol Dietary Intervention On LDL Sub-Groups In Dyslipidemic Turkish Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04894318
• Other study ID #: TYL-2018-8497
• Status: Completed
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: July 25, 2019

Study information

• Verified date: May 2021
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare LDL sub-group concentration before and after a diet with low-fat and low-cholesterol prescribed to dyslipidemic patients for 12 weeks.

Description:

The study was conducted between January 2018-July 2019 in Erciyes University Health Application and Research Center. This study was planned as a clinical trial for treatment and 47 patients were included. All participants were given written consent. The study was evaluated to be ethically appropriate by Erciyes University Faculty of Medicine Clinical Research Ethics Committee.

A low-fat (<30% of total energy), and low-cholesterol (<200 mg/day) diet was planned for the participants at the baseline, according to the gender, lifestyle, working conditions, nutritional habits, BMI, concomitant diseases and risk conditions. The patients were called for monthly controls and followed up for a total of 12 weeks. When the patients admitted at the first and second months, Body Impedance Analyzer (BIA) measurements were performed and dietary adherence was controlled. If necessary, the energy requirements of the patients were re-calculated and their diets were re-newed and if the patients had any questions on the diet, they were answered. Blood samples were taken from the patients at the baseline and after 12 weeks and the effects of a low-fat, low-cholesterol diet on biochemical and anthropometric measurements were evaluated. Energy restricted diet were planed for overweight and obese patients (~ 500-1000 kcal/day). In addition, patients were recommended to walk at a moderate speed for at least 30-40 min per day.

Data Collection A questionnaire including socio-demographic characteristics, nutritional habits, physical activity status, and comorbid diseases was filled by the researcher. The food consumption frequency of the participants was evaluated by dividing the frequencies into four groups as consuming 5-6 times daily, consuming every other day, consuming 1-2 times a week and consuming 1-2 times a month or never at all. Food consumption records were also taken from each patient. Physical activity was questioned by the 'International Physical Activity Questionnaire (short form).

Statistical analysis The suitability of the data for normal distribution was evaluated by histogram, q-q graphs and Shapiro-Wilk test. Variance homogeneity was tested with Levene test. Two groups independent samples t-test and Mann-Whitney U-tests were used for quantitative variables. In the qualitative data, two repeated measurement comparisons were used with McNemar-Bowker test. The paired t-test and Wilcoxon tests were used in the quantitative data for two repeated measurements. Spearman analysis was used to evaluate the relationship between quantitative variables. Data analysis was performed by Turcosa Cloud (Turcosa Ltd Co) statistical software. Significance level was accepted as p<0.05.

Anthropometric measurements After the completing the questionnaire, anthropometric measurements were taken. Body weight: When the patient was in fasting state in the morning measured with thin clothes. While measuring body weight, the individual was asked to remove his heavy clothes (coats, jackets, etc.), belongings in the pockets (wallet, key ring, phone, address book etc.) and shoes. Attention is given to place the feet on the balance and to ensure a balanced distribution of body weight to the two feet. The individual was asked to stand upright and without moving. The measurement was made with a sensitivity of 0.1 kg (100 g). Height: The height was measured with a stadiometer while the feet were side-by-side and the head was in the Frankfort plane. Body mass index (BMI): BMI was calculated by dividing subjects body weight by square of his/her height. [BMI = Body weight (kg)/height (m)²]. Waist circumference: The waist circumference was measured with a non-elastic tape measuring the mid-point between the lower rib and the crista iliac crest. Waist-to height ratio: It was calculated by the division of waist circumference (cm) into height (cm). Neck circumference: Neck circumference was measured with a non-elastic plastic band from the middle of the neck height between the middle cervical spine and the middle anterior neck with a sensitivity of 0.1 cm. In men with Adam's apple, it was measured just below the protrusion. BIA measurements: Body composition of the participants was determined with Tanita BC-418 MA (Tanita Corporation of America, Inc., Arlington Heights, IL) device. In order to make accurate measurements; metal jewelery on individuals, socks, clothes that will affect the measurement excessively were removed and information about the person's age, height, gender and whether they are dealing with regular sports activities were entered into the device. Then, individuals were removed from the instrument with their heels on the electrodes and the measurement was made. It was taken into consideration that participants did not perform intensive physical activity 24-48 hours before the measurement. It was observed that individuals did not have heavy physical activity 24-48 hours before the measurement, they were fasted for at least 4 hours, no alcohol was used 24 hours before, and they did not consume too much beverages (tea, coffee) before the measurement (at least 4 hours).

Biochemical parameters In the Endocrinology polyclinic; the patients were diagnosed with dyslipidemia by an endocrinologist and their fasting blood glucose (mg/dL), triglycerides (mg/dL), total cholesterol (mg/dL), HDL-cholesterol (mg/dL), LDL-cholesterol (mg/dL) levels were evaluated. Patients were selected according to the inclusion criteria and blood was drawn after fasting for at least 10-12 hours. Very low density lipoprotein (VLDL (mg/dL)), large-LDL (mg/dL), small-LDL (mg/dL) medium density lipoprotein (IDL (mg/dL)) (Mid A, B, C) values. After centrifugation, blood samples were kept in the freezer at -80°C in Erciyes University Endocrinology Service until analysis period. For patients who were not initially evaluated for insulin (mg/dL), some blood was collected and delivered to Erciyes University Blood Collection Department and studied at the Central Biochemistry Laboratory of Erciyes University. Fasting blood glucose, triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol levels were measured by spectrophotometric method using Roche Diagnostics (Basel, Switzerland). Insulin was measured by the ECLIA study method using the Roche Diagnostics (Mannheim, Germany). LDL subgroups were measured in serum samples using a Lipoprint System (Quantimetrix Inc., Redondo Beach, CA, USA). This system separates lipoproteins in a non-denaturing gel gradient of polyacrylamide based on net surface charge and size. The dye binds proportionally to the relative amount of cholesterol in each lipoprotein. After the electrophoresis, densitometric analyzes and proportional concentrations of lipoprotein classes and subclasses were calculated on the Lipoware software. In this system, VLDL, IDL corresponding to 3 midbands (Mid A, B, C) and 7 LDL subgroups: LDL-1 to -2 (large, bouyant, pattern A); LDL-3 to -7 (small, dense; pattern B). The system also gives the average LDL particle size. Type A if particle size was ≥268Â, medium level if particle size was 265-268Â, type B if particle size was ≤265Â.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 25, 2019
• Est. primary completion date: September 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria

• Being diagnosed with dyslipidemia by an endocrinologist

• Those who do not have a history of diabetes, hyperthyroidism, hypothyroidism (including those who have hypothyroidism but receive replacement therapy)

• 25-65 years

• Body Mass Index (BMI) = 25-40 kg/m²

• Smoking three or less than three cigarettes a day

• Not using herbal supplements.

• Not being in pregnancy or lactation period

• Volunteering to participate in the study

Exclusion Criteria:

• Not being diagnosed with dyslipidemia

• Using a drug that affects the lipid profile

• Not being in the age range of 25-65

• BMI = 25-40 kg/m² not

• Smoking more than three cigarettes a day

• Using herbal supplements

• Being in the pregnancy or lactation period

• Not willing to participate in the study

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Behavioral:
• Low-fat and low-cholesterol diet
Low-fat (<30% of total energy) and low-cholesterol (<200mg/day) diet total of 12 weeks

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri	Melikgazi

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Baseline LDL subgroups at 12 weeks	LDL subgroups were measured in serum samples using a Lipoprint System (Quantimetrix Inc., Redondo Beach, CA, USA). This system separates lipoproteins in a non-denaturing gel gradient of polyacrylamide based on net surface charge and size. The dye binds proportionally to the relative amount of cholesterol in each lipoprotein. After the electrophoresis, densitometric analyzes and proportional concentrations of lipoprotein classes and subclasses were calculated on the Lipoware software. In this system, VLDL, IDL corresponding to 3 midbands (Mid A, B, C) and 7 LDL subgroups: LDL-1 to -2 (large, bouyant, pattern A); LDL-3 to -7 (small, dense; pattern B). The system also gives the average LDL particle size. Type A if particle size was =268Â, medium level if particle size was 265-268Â, type B if particle size was =265Â	Baseline and 12 weeks
Secondary	Change in Baseline body weight at 12 weeks	Body weight in kilograms	Baseline and 12 weeks
Secondary	Change in Baseline height at 12 weeks	Height in centimeter	Baseline and 12 weeks
Secondary	Change in Baseline Body mass index (BMI) at 12 weeks	Body mass index (BMI) was calculated by dividing subjects body weight by square of his/her height. [BMI = Body weight (kg)/height (m)²]	Baseline and 12 weeks
Secondary	Change in Baseline waist circumference at 12 weeks	Waist circumference in centimeter	Baseline and 12 weeks
Secondary	Change in Baseline waist-to-height ratio at 12 weeks	Waist-to-height ratio was calculated by the division of waist circumference (cm) into height (cm)	Baseline and 12 weeks
Secondary	Change in Baseline neck circumference at 12 weeks	Neck circumference in centimeter	Baseline and 12 weeks
Secondary	Change in Baseline fat percentage at 12 weeks	Fat percentage (%) was measured by Tanita BC-418 MA (Tanita Corporation of America, Inc., Arlington Heights, IL)	Baseline and 12 weeks
Secondary	Change in Baseline muscle mass at 12 weeks	Muscle mass was measured by Tanita BC-418 MA (Tanita Corporation of America, Inc., Arlington Heights, IL)	Baseline and 12 weeks
Secondary	Change in Baseline blood sugar at 12 weeks	Blood sugar (mg/dL) was measured after at least 10-12 hours of fasting. Fasting blood glucose was measured by spectrophotometric method using Roche Diagnostics (Basel, Switzerland).	Baseline and 12 weeks
Secondary	Change in Baseline triglycerides at 12 weeks	Triglycerides (mg/dL) was measured after at least 10-12 hours of fasting. Triglyceride was measured by spectrophotometric method using Roche Diagnostics (Basel, Switzerland). Triglycerides measurement is used in the diagnosis of dyslipidemia and the risk of cardiovascular disease increases above 150 mg/dL.	Baseline and 12 weeks
Secondary	Change in Baseline total cholesterol at 12 weeks	Total cholesterol (mg/dL) was measured after at least 10-12 hours of fasting. Total cholesterol was measured by spectrophotometric method using Roche Diagnostics (Basel, Switzerland). Total cholesterol measurement is used in the diagnosis of dyslipidemia and the risk of cardiovascular disease increases above 200 mg/dL.	Baseline and 12 weeks
Secondary	Change in Baseline HDL-cholesterol at 12 weeks	HDL-cholesterol (mg/dL) was measured after at least 10-12 hours of fasting. HDL-cholesterol was measured by spectrophotometric method using Roche Diagnostics (Basel, Switzerland). HDL cholesterol measurement is used in the diagnosis of dyslipidemia and the increase in HDL cholesterol reduces the risk of cardiovascular disease.	Baseline and 12 weeks
Secondary	Change in Baseline LDL-cholesterol at 12 weeks	LDL-cholesterol (mg/dL) was measured after at least 10-12 hours of fasting. LDL-cholesterol levels was measured by spectrophotometric method using Roche Diagnostics (Basel, Switzerland). LDL-cholesterol measurement is used in the diagnosis of dyslipidemia and the risk of cardiovascular disease increases above 130 mg/dL.	Baseline and 12 weeks
Secondary	Change in Baseline insulin at 12 weeks	LDL-cholesterol (mg/dL) was measured after at least 10-12 hours of fasting. Insulin was measured by the ECLIA study method using the Roche Diagnostics (Mannheim, Germany).	Baseline and 12 weeks
Secondary	Change in Baseline blood pressure Levels at 12 weeks	Blood pressure was measured with a device called a sphygmomanometer while patients were at rest. High blood pressure is one of the most important risk factors for cardiovascular disease.	Baseline and 12 weeks

External Links

•   TEMD Obezite, Dislipidemi, Hipertansiyon Çalisma Grubu' TEMD Dislipidemi Tani ve Tedavi Kilavuzu', Ankara, Nisan 2019: 13-40 (in Turkish)
•   Türkiye Beslenme Rehberi TUBER 2015, T.C. Saglik Bakanligi Yayin No: 1031, Ankara 2016.Erisim:[https://dosyasb.saglik.gov.tr/Eklenti/10915,tuberturkiyebeslenme-rehberipdf.pdf], Date of access: 18.10.2018 (in Turkish).
•   Yardim N, Çelikay N, Aykul F, Kelat Z. Diyetisyenler için Hasta Izlem Rehberi Agirlik Yönetimi El Kitabi. Ed: Rakicioglu N, Samur G, Basoglu S. Ankara 2017; 75-77 (in Turkish).