Effect of Dietary Intervention on LDL-C and Lipoprotein Subclasses Distribution in Patients With Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

Effect of Dietary Intervention on LDL-C Levels and Lipoprotein Subclasses Distribution in Patients With Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04148976
• Other study ID #: 706
• Status: Completed
• Phase: N/A
• Start date: February 28, 2013
• Est. completion date: December 18, 2018

Study information

• Verified date: November 2019
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of the present study was to elucidate the effect of a combination of functional foods on the low-density lipoprotein cholesterol (LDL-C) levels and on the distribution of the lipoprotein subclasses in subjects with hypercholesterolemia. To accomplish the latter, subjects that met the inclusion criteria and had mild hypercholesterolemia (Total cholesterol >200mg/dL, and LDL-C >130mg/dL <190 mg/dL) were recruited for double-blind, parallel, controlled dietary intervention study. After two weeks of dietary standardization with an isocaloric diet, subjects were randomized and allocated to either placebo or a dietary portfolio treatment for two months. The secondary endpoints were the size of the different lipoprotein subclasses, total cholesterol levels, high density -lipoprotein cholesterol (HDL-C) levels, apolipoprotein B, triglycerides, total/HDL-C ratio, apolipoprotein B/apolipoprotein A ratio, and anthropometric measurements.

Description:

The present work took place at the Department of Physiology of Nutrition at the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ). The study followed a randomized, controlled, double-blind, parallel design encompassing five visits. On the first visit, volunteers were screened for eligibility criteria. Subjects that met the inclusion criteria were then invited to a second visit. Herein, volunteers received a thorough explanation of the experimental maneuver, as well as the overall objectives of the study. Thereafter, subjects who agreed to participate signed a consent form.

Upon agreement, assessment of habitual dietary intake and physical activity was obtained by 24-hour dietary recalls, food frequency questionnaire (FFQ), and by the International Physical Activity Questionnaire (IPAQ), respectively. Additionally, anthropometric measurements and blood samples were registered and collected. Then, volunteers underwent dietary standardization for two weeks with isocaloric diets (LSFD), which followed the National Cholesterol Education Program (NCEP) , Adult Treatment Panel III (ATP III) criteria. That is, 50-60% carbohydrates, 15% protein, 25-35% fat,<7% saturated fat,≤ 200mg of dietary cholesterol, 20-35g of fiber, and 2000mg/d of sodium.

On the third visit, subjects were randomly allocated to either LSFD plus placebo or an LSFD plus the dietary portfolio (DP). Of note, the prescribed diets were matched to the volunteers' habitual caloric intake -considering the energy provided by the placebo or DP- to avoid variability of the endpoint variables due to weight-loss. The DP and placebo provided 200kcal; the DP included 25g of soy protein, 14g of dehydrated nopal,14g of oats, 4g of chia seeds, 4g of inulin, and 0.15g of flavoring. The placebo consisted of 30g of calcium caseinate, 30g of maltodextrin, and 0.2g of flavoring. The organoleptic characteristics and packaging were similar between treatments. Subjects were instructed to consume two packets per day, preferably with breakfast and dinner. The content of each packet (30g of product) was dissolved in 250-300ml of water.

Volunteers followed the given treatment for two consecutive months, during which two follow-up visits took place. Blood samples, anthropometric characteristics, and blood pressure were obtained in all visits.

Compliance to diet, placebo, and DP was assessed with 24-hour dietary recalls, 3-day dietary records, and with the number of empty packets returned on the corresponding visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Men and women

• Body mass index (BMI) 25 to = 39.9 kg/m2

• Adults between 20 and 60 years of age

• Total cholesterol levels of >200mg/dL in serum

• LDL-C levels =130mg/dL =190mg/dL

• Literate subjects

• Signature of informed consent

Exclusion Criteria:

• Subjects with diabetes

• Diseases that produce obesity or diabetes

• Cardiovascular events

• Weight-loss of = 3kg on the preceding months to the study

• Catabolic diseases such as cancer and acquired immunodeficiency syndrome

• Pregnancy and breastfeeding

• Positive Smoking

• Pharmacological treatment including:

Antihypertensive drugs Hypoglycemic agents Statins, fibrates or any other treatment for dyslipidemia Steroid medications Chemotherapy, immunosuppressants, and radiotherapy Anorexigens or other medication to induce weight-loss

• Subjects with high cardiovascular risk

• Subjects with symptomatic digestive pathologies

Related Conditions & MeSH terms

• Disease
• Dyslipidemias
• Hypercholesterolemia

Intervention

Dietary Supplement:
• Placebo
A mixture of maltodextrins and calcium caseinate divided into 30g individual packets.
• Dietary portfolio
A mixture of functional foods divided into 30g individual packets.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

References & Publications (8)

Ascencio C, Torres N, Isoard-Acosta F, Gómez-Pérez FJ, Hernández-Pando R, Tovar AR. Soy protein affects serum insulin and hepatic SREBP-1 mRNA and reduces fatty liver in rats. J Nutr. 2004 Mar;134(3):522-9. — View Citation

Guevara-Cruz M, Flores-López AG, Aguilar-López M, Sánchez-Tapia M, Medina-Vera I, Díaz D, Tovar AR, Torres N. Improvement of Lipoprotein Profile and Metabolic Endotoxemia by a Lifestyle Intervention That Modifies the Gut Microbiota in Subjects With Metabolic Syndrome. J Am Heart Assoc. 2019 Sep 3;8(17):e012401. doi: 10.1161/JAHA.119.012401. Epub 2019 Aug 27. — View Citation

Guevara-Cruz M, Tovar AR, Aguilar-Salinas CA, Medina-Vera I, Gil-Zenteno L, Hernández-Viveros I, López-Romero P, Ordaz-Nava G, Canizales-Quinteros S, Guillen Pineda LE, Torres N. A dietary pattern including nopal, chia seed, soy protein, and oat reduces serum triglycerides and glucose intolerance in patients with metabolic syndrome. J Nutr. 2012 Jan;142(1):64-9. doi: 10.3945/jn.111.147447. Epub 2011 Nov 16. — View Citation

Jenkins DJ, Josse AR, Wong JM, Nguyen TH, Kendall CW. The portfolio diet for cardiovascular risk reduction. Curr Atheroscler Rep. 2007 Dec;9(6):501-7. Review. — View Citation

López-Romero P, Pichardo-Ontiveros E, Avila-Nava A, Vázquez-Manjarrez N, Tovar AR, Pedraza-Chaverri J, Torres N. The effect of nopal (Opuntia ficus indica) on postprandial blood glucose, incretins, and antioxidant activity in Mexican patients with type 2 diabetes after consumption of two different composition breakfasts. J Acad Nutr Diet. 2014 Nov;114(11):1811-8. doi: 10.1016/j.jand.2014.06.352. Epub 2014 Aug 12. — View Citation

Medina-Vera I, Sanchez-Tapia M, Noriega-López L, Granados-Portillo O, Guevara-Cruz M, Flores-López A, Avila-Nava A, Fernández ML, Tovar AR, Torres N. A dietary intervention with functional foods reduces metabolic endotoxaemia and attenuates biochemical abnormalities by modifying faecal microbiota in people with type 2 diabetes. Diabetes Metab. 2019 Apr;45(2):122-131. doi: 10.1016/j.diabet.2018.09.004. Epub 2018 Sep 25. — View Citation

Mora S, Otvos JD, Rifai N, Rosenson RS, Buring JE, Ridker PM. Lipoprotein particle profiles by nuclear magnetic resonance compared with standard lipids and apolipoproteins in predicting incident cardiovascular disease in women. Circulation. 2009 Feb 24;119(7):931-9. doi: 10.1161/CIRCULATIONAHA.108.816181. Epub 2009 Feb 9. — View Citation

Torres N, Guevara-Cruz M, Granados J, Vargas-Alarcón G, González-Palacios B, Ramos-Barragan VE, Quiroz-Olguín G, Flores-Islas IM, Tovar AR. Reduction of serum lipids by soy protein and soluble fiber is not associated with the ABCG5/G8, apolipoprotein E, and apolipoprotein A1 polymorphisms in a group of hyperlipidemic Mexican subjects. Nutr Res. 2009 Oct;29(10):728-35. doi: 10.1016/j.nutres.2009.09.013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low density lipoprotein- cholesterol (LDL-C)	Plasma total LDL-C (mg/dl)	Change in total LDL-C after 2.5 months of treatment
Primary	Lipoprotein subclasses	High density lipoprotein (HDL), low density lipoprotein (LDL), and very low density lipoprotein (VLDL) subclasses (small medium and large) as measure by nuclear magnetic resonance spectroscopy (NMR) in µmol/L.	Change in small, medium and large LDL, HDL and VLDL lipoprotein subclasses after 2.5 months of treatment
Secondary	Total cholesterol	Plasma total cholesterol (mg/dL)	Change in total cholesterol after 2.5 months of treatment
Secondary	Triglycerides	Plasma triglycerides (mg/dL)	Change in triglycerides after 2.5 months of treatment
Secondary	High density lipoprotein cholesterol (HDL-C)	Plasma HDL cholesterol (mg/dL)	Change after 2.5 months of treatment
Secondary	Apolipoprotein B	Change in apolipoprotein B in	Change after 2.5 months of treatment
Secondary	Apolipoprotein A	Change in apolipoprotein A in plasma	Change after 2.5 months of treatment
Secondary	Total/ high density lipoprotein cholesterol (HDL-C) ratio	Change in total/ high density lipoprotein cholesterol (HDL-C) ratio	Change after 2.5 months of treatment
Secondary	Apolipoprotein B/Apolipoprotein A ratio	Change in Apolipoprotein B / Apolipoprotein A ratio	Change after 2.5 months of treatment