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

NCT04894318 | Completed

• 1 other identifier: TYL-2018-8497
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyslipidemias

Keywords

Dyslipidemia, Low-Fat Low-Cholesterol Diet, LDL Sub-groups

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Change in Baseline body weight at 12 weeks

  Baseline and 12 weeks

• Change in Baseline height at 12 weeks

  Baseline and 12 weeks

• Change in Baseline Body mass index (BMI) at 12 weeks

  Baseline and 12 weeks

• Change in Baseline waist circumference at 12 weeks

  Baseline and 12 weeks

• Change in Baseline waist-to-height ratio at 12 weeks

  Baseline and 12 weeks

Study Arms (1)

Low-fat, low-cholesterol diet

OTHER

Patients diagnosed with dyslipidemia by the endocrinologist were followed up for 12 weeks with a low-fat, low-cholesterol diet on a monthly basis, provided that they were suitable for each.

Behavioral: Low-fat and low-cholesterol diet

Interventions

Low-fat and low-cholesterol diet BEHAVIORAL

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

Low-fat, low-cholesterol diet

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Location

Related Publications (33)

• Jellinger PS, Smith DA, Mehta AE, Ganda O, Handelsman Y, Rodbard HW, Shepherd MD, Seibel JA; AACE Task Force for Management of Dyslipidemia and Prevention of Atherosclerosis. American Association of Clinical Endocrinologists' Guidelines for Management of Dyslipidemia and Prevention of Atherosclerosis. Endocr Pract. 2012 Mar-Apr;18 Suppl 1:1-78. doi: 10.4158/ep.18.s1.1. No abstract available.

  PMID: 22522068 RESULT

• Bayram F, Kocer D, Gundogan K, Kaya A, Demir O, Coskun R, Sabuncu T, Karaman A, Cesur M, Rizzo M, Toth PP, Gedik V. Prevalence of dyslipidemia and associated risk factors in Turkish adults. J Clin Lipidol. 2014 Mar-Apr;8(2):206-16. doi: 10.1016/j.jacl.2013.12.011. Epub 2014 Jan 19.

  PMID: 24636181 RESULT

• Mahley RW, Pepin J, Palaoglu KE, Malloy MJ, Kane JP, Bersot TP. Low levels of high density lipoproteins in Turks, a population with elevated hepatic lipase. High density lipoprotein characterization and gender-specific effects of apolipoprotein e genotype. J Lipid Res. 2000 Aug;41(8):1290-301.

  PMID: 10946017 RESULT

• Bedard A, Corneau L, Lamarche B, Dodin S, Lemieux S. Sex Differences in the Impact of the Mediterranean Diet on LDL Particle Size Distribution and Oxidation. Nutrients. 2015 May 15;7(5):3705-23. doi: 10.3390/nu7053705.

  PMID: 25988764 RESULT

• El Harchaoui K, van der Steeg WA, Stroes ES, Kuivenhoven JA, Otvos JD, Wareham NJ, Hutten BA, Kastelein JJ, Khaw KT, Boekholdt SM. Value of low-density lipoprotein particle number and size as predictors of coronary artery disease in apparently healthy men and women: the EPIC-Norfolk Prospective Population Study. J Am Coll Cardiol. 2007 Feb 6;49(5):547-53. doi: 10.1016/j.jacc.2006.09.043. Epub 2007 Jan 22.

  PMID: 17276177 RESULT

• Ai M, Otokozawa S, Asztalos BF, Ito Y, Nakajima K, White CC, Cupples LA, Wilson PW, Schaefer EJ. Small dense LDL cholesterol and coronary heart disease: results from the Framingham Offspring Study. Clin Chem. 2010 Jun;56(6):967-76. doi: 10.1373/clinchem.2009.137489. Epub 2010 Apr 29.

  PMID: 20431054 RESULT

• Gerber PA, Nikolic D, Rizzo M. Small, dense LDL: an update. Curr Opin Cardiol. 2017 Jul;32(4):454-459. doi: 10.1097/HCO.0000000000000410.

  PMID: 28426445 RESULT

• Feingold KR. Introduction to Lipids and Lipoproteins. 2024 Jan 14. In: Feingold KR, Adler RA, Ahmed SF, Anawalt B, Blackman MR, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hamilton E, Hofland J, Jan de Beur S, Kalra S, Kaltsas G, Kapoor N, Kim M, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, Shah AS, Sperling MA, Stratakis CA, Trence DL, Wilson DP, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from http://www.ncbi.nlm.nih.gov/books/NBK305896/

  PMID: 26247089 RESULT

• Ivanova EA, Myasoedova VA, Melnichenko AA, Grechko AV, Orekhov AN. Small Dense Low-Density Lipoprotein as Biomarker for Atherosclerotic Diseases. Oxid Med Cell Longev. 2017;2017:1273042. doi: 10.1155/2017/1273042. Epub 2017 May 7.

  PMID: 28572872 RESULT

• Guay V, Lamarche B, Charest A, Tremblay AJ, Couture P. Effect of short-term low- and high-fat diets on low-density lipoprotein particle size in normolipidemic subjects. Metabolism. 2012 Jan;61(1):76-83. doi: 10.1016/j.metabol.2011.06.002. Epub 2011 Aug 3.

  PMID: 21816443 RESULT

• Authors/Task Force Members; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2019 ESC/EAS guidelines for the management of dyslipidaemias: Lipid modification to reduce cardiovascular risk. Atherosclerosis. 2019 Nov;290:140-205. doi: 10.1016/j.atherosclerosis.2019.08.014. Epub 2019 Aug 31. No abstract available.

  PMID: 31591002 RESULT

• Schwingshackl L, Hoffmann G. Comparison of effects of long-term low-fat vs high-fat diets on blood lipid levels in overweight or obese patients: a systematic review and meta-analysis. J Acad Nutr Diet. 2013 Dec;113(12):1640-61. doi: 10.1016/j.jand.2013.07.010. Epub 2013 Oct 17.

  PMID: 24139973 RESULT

• Wu L, Ma D, Walton-Moss B, He Z. Effects of low-fat diet on serum lipids in premenopausal and postmenopausal women: a meta-analysis of randomized controlled trials. Menopause. 2014 Jan;21(1):89-99. doi: 10.1097/GME.0b013e318291f5c2.

  PMID: 23736858 RESULT

• Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.

  PMID: 22018588 RESULT

• Zen V, Fuchs FD, Wainstein MV, Goncalves SC, Biavatti K, Riedner CE, Fuchs FC, Wainstein RV, Rhoden EL, Ribeiro JP, Fuchs SC. Neck circumference and central obesity are independent predictors of coronary artery disease in patients undergoing coronary angiography. Am J Cardiovasc Dis. 2012;2(4):323-30. Epub 2012 Oct 25.

  PMID: 23173107 RESULT

• Hoefner DM, Hodel SD, O'Brien JF, Branum EL, Sun D, Meissner I, McConnell JP. Development of a rapid, quantitative method for LDL subfractionation with use of the Quantimetrix Lipoprint LDL System. Clin Chem. 2001 Feb;47(2):266-74.

  PMID: 11159775 RESULT

• Kostis JB. The importance of managing hypertension and dyslipidemia to decrease cardiovascular disease. Cardiovasc Drugs Ther. 2007 Aug;21(4):297-309. doi: 10.1007/s10557-007-6032-4.

  PMID: 17605096 RESULT

• Aoki T, Yagi H, Sumino H, Tsunekawa K, Araki O, Kimura T, Nara M, Ogiwara T, Nakajima K, Murakami M. Relationship between carotid artery intima-media thickness and small dense low-density lipoprotein cholesterol concentrations measured by homogenous assay in Japanese subjects. Clin Chim Acta. 2015 Mar 10;442:110-4. doi: 10.1016/j.cca.2015.01.010. Epub 2015 Jan 17.

  PMID: 25603407 RESULT

• Taylan E, Tuncel EP. Distribution of LDL subgroups in patients with hyperlipidemia. Turk J Med Sci. 2016 Feb 17;46(2):374-80. doi: 10.3906/sag-1410-40.

  PMID: 27511499 RESULT

• Jacobson TA, Maki KC, Orringer CE, Jones PH, Kris-Etherton P, Sikand G, La Forge R, Daniels SR, Wilson DP, Morris PB, Wild RA, Grundy SM, Daviglus M, Ferdinand KC, Vijayaraghavan K, Deedwania PC, Aberg JA, Liao KP, McKenney JM, Ross JL, Braun LT, Ito MK, Bays HE, Brown WV, Underberg JA; NLA Expert Panel. National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 2. J Clin Lipidol. 2015 Nov-Dec;9(6 Suppl):S1-122.e1. doi: 10.1016/j.jacl.2015.09.002. Epub 2015 Sep 18.

  PMID: 26699442 RESULT

• Zhu Z, Wu F, Lu Y, Wang Z, Zang J, Yu H, Guo C, Jia X, Shen X, Ding G. The Association of Dietary Cholesterol and Fatty Acids with Dyslipidemia in Chinese Metropolitan Men and Women. Nutrients. 2018 Jul 25;10(8):961. doi: 10.3390/nu10080961.

  PMID: 30044444 RESULT

• Ensign W, Hill N, Heward CB. Disparate LDL phenotypic classification among 4 different methods assessing LDL particle characteristics. Clin Chem. 2006 Sep;52(9):1722-7. doi: 10.1373/clinchem.2005.059949. Epub 2006 Jun 1.

  PMID: 16740651 RESULT

• Ohmura H, Mokuno H, Sawano M, Hatsumi C, Mitsugi Y, Watanabe Y, Daida H, Yamaguchi H. Lipid compositional differences of small, dense low-density lipoprotein particle influence its oxidative susceptibility: possible implication of increased risk of coronary artery disease in subjects with phenotype B. Metabolism. 2002 Sep;51(9):1081-7. doi: 10.1053/meta.2002.34695.

  PMID: 12200749 RESULT

• Chiu S, Williams PT, Krauss RM. Effects of a very high saturated fat diet on LDL particles in adults with atherogenic dyslipidemia: A randomized controlled trial. PLoS One. 2017 Feb 6;12(2):e0170664. doi: 10.1371/journal.pone.0170664. eCollection 2017.

  PMID: 28166253 RESULT

• Hosaka S, Okada Y, Maruyama K, Maruyama D. Increased intima-media thickness of the carotid artery in Japanese female type 2 diabetic patients with 'midband lipoprotein'. Diabetes Res Clin Pract. 2007 Mar;75(3):333-8. doi: 10.1016/j.diabres.2006.07.032. Epub 2006 Sep 8.

  PMID: 16963151 RESULT

• Srisawasdi P, Vanavanan S, Rochanawutanon M, Pornsuriyasak P, Tantrakul V, Kruthkul K, Kotani K. Heterogeneous properties of intermediate- and low-density lipoprotein subpopulations. Clin Biochem. 2013 Oct;46(15):1509-15. doi: 10.1016/j.clinbiochem.2013.06.021. Epub 2013 Jul 2.

  PMID: 23830843 RESULT

• Klop B, Elte JW, Cabezas MC. Dyslipidemia in obesity: mechanisms and potential targets. Nutrients. 2013 Apr 12;5(4):1218-40. doi: 10.3390/nu5041218.

  PMID: 23584084 RESULT

• Taylor AE, Ebrahim S, Ben-Shlomo Y, Martin RM, Whincup PH, Yarnell JW, Wannamethee SG, Lawlor DA. Comparison of the associations of body mass index and measures of central adiposity and fat mass with coronary heart disease, diabetes, and all-cause mortality: a study using data from 4 UK cohorts. Am J Clin Nutr. 2010 Mar;91(3):547-56. doi: 10.3945/ajcn.2009.28757. Epub 2010 Jan 20.

  PMID: 20089729 RESULT

• Frimel TN, Sinacore DR, Villareal DT. Exercise attenuates the weight-loss-induced reduction in muscle mass in frail obese older adults. Med Sci Sports Exerc. 2008 Jul;40(7):1213-9. doi: 10.1249/MSS.0b013e31816a85ce.

  PMID: 18580399 RESULT

• Newman AB, Lee JS, Visser M, Goodpaster BH, Kritchevsky SB, Tylavsky FA, Nevitt M, Harris TB. Weight change and the conservation of lean mass in old age: the Health, Aging and Body Composition Study. Am J Clin Nutr. 2005 Oct;82(4):872-8; quiz 915-6. doi: 10.1093/ajcn/82.4.872.

  PMID: 16210719 RESULT

• Yang XP, Reckelhoff JF. Estrogen, hormonal replacement therapy and cardiovascular disease. Curr Opin Nephrol Hypertens. 2011 Mar;20(2):133-8. doi: 10.1097/MNH.0b013e3283431921.

  PMID: 21178615 RESULT

• Pai JK, Manson JE. Acceleration of cardiovascular risk during the late menopausal transition. Menopause. 2013 Jan;20(1):1-2. doi: 10.1097/gme.0b013e318278e9b4. No abstract available.

  PMID: 23266836 RESULT

• Stock EO, Redberg R. Cardiovascular disease in women. Curr Probl Cardiol. 2012 Nov;37(11):450-526. doi: 10.1016/j.cpcardiol.2012.07.001.

  PMID: 23047015 RESULT

Related Links

• TEMD Obezite, Dislipidemi, Hipertansiyon Çalışma Grubu' TEMD Dislipidemi Tanı ve Tedavi Kılavuzu', Ankara, Nisan 2019: 13-40 (in Turkish)
• Türkiye Beslenme Rehberi TUBER 2015, T.C. Saglık Bakanlıgı Yayın No: 1031, Ankara 2016.Erisim:\[https://dosyasb.saglik.gov.tr/Eklenti/10915,tuberturkiyebeslenme-rehberipdf.pdf\], Date of access: 18.10.2018 (in Turkish).

MeSH Terms

Conditions

Dyslipidemias

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ülger Kaçar Mutlutürk, Phd

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

• Fahri Bayram, Prof.Dr.

  TC Erciyes University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 20, 2021
• Study Start: September 5, 2017
• Primary Completion: September 5, 2018
• Study Completion: July 25, 2019
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date
• Access Criteria: Anyone who wishes to access the date

Locations

TU (1)