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

NCT04148976 | Completed

• 1 other identifier: 706
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypercholesterolemia; Disease; Dyslipidemias

Keywords

hypercholesterolemia; dietary portfolio; soy protein; LDL-C; lipoprotein subclasses; nopal; chia seed; functional foods

Outcome Measures

Primary Outcomes (2)

• Low density lipoprotein- cholesterol (LDL-C)

  Plasma total LDL-C (mg/dl)

  Change in total LDL-C after 2.5 months of treatment

• 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 Outcomes (7)

• Total cholesterol

  Change in total cholesterol after 2.5 months of treatment

• Triglycerides

  Change in triglycerides after 2.5 months of treatment

• High density lipoprotein cholesterol (HDL-C)

  Change after 2.5 months of treatment

• Apolipoprotein B

  Change after 2.5 months of treatment

• Apolipoprotein A

  Change after 2.5 months of treatment

Study Arms (2)

Placebo (P)

PLACEBO COMPARATOR

The placebo consisted of 30g of calcium caseinate, 30g of maltodextrin, and 0.2g of flavoring. The placebo was provided in a dehydrated form in a packet containing 30g each provided twice a day. The content of each packet was dissolved in 250ml of water.

Dietary Supplement: Placebo

Dietary Portfolio (DP)

EXPERIMENTAL

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 DP was provided in a dehydrated form in a packet containing 30g each. The content of each packet was dissolved in 250ml of water.

Dietary Supplement: Dietary portfolio

Interventions

Placebo DIETARY_SUPPLEMENT

A mixture of maltodextrins and calcium caseinate divided into 30g individual packets.

Placebo (P)

Dietary portfolio DIETARY_SUPPLEMENT

A mixture of functional foods divided into 30g individual packets.

Dietary Portfolio (DP)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Related Publications (9)

• Guevara-Cruz M, Tovar AR, Aguilar-Salinas CA, Medina-Vera I, Gil-Zenteno L, Hernandez-Viveros I, Lopez-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.

  PMID: 22090467 BACKGROUND

• Guevara-Cruz M, Flores-Lopez AG, Aguilar-Lopez M, Sanchez-Tapia M, Medina-Vera I, Diaz 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.

  PMID: 31451009 BACKGROUND

• 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. doi: 10.1007/s11883-007-0067-7.

  PMID: 18377791 BACKGROUND

• 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.

  PMID: 19204302 BACKGROUND

• Torres N, Guevara-Cruz M, Granados J, Vargas-Alarcon G, Gonzalez-Palacios B, Ramos-Barragan VE, Quiroz-Olguin 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.

  PMID: 19917453 BACKGROUND

• Ascencio C, Torres N, Isoard-Acosta F, Gomez-Perez FJ, Hernandez-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. doi: 10.1093/jn/134.3.522.

  PMID: 14988441 BACKGROUND

• Lopez-Romero P, Pichardo-Ontiveros E, Avila-Nava A, Vazquez-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.

  PMID: 25132122 BACKGROUND

• Medina-Vera I, Sanchez-Tapia M, Noriega-Lopez L, Granados-Portillo O, Guevara-Cruz M, Flores-Lopez A, Avila-Nava A, Fernandez 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.

  PMID: 30266575 BACKGROUND

• Vazquez-Manjarrez N, Guevara-Cruz M, Flores-Lopez A, Pichardo-Ontiveros E, Tovar AR, Torres N. Effect of a dietary intervention with functional foods on LDL-C concentrations and lipoprotein subclasses in overweight subjects with hypercholesterolemia: Results of a controlled trial. Clin Nutr. 2021 May;40(5):2527-2534. doi: 10.1016/j.clnu.2021.02.048. Epub 2021 Mar 6.

  PMID: 33932799 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Disease; Dyslipidemias

Condition Hierarchy (Ancestors)

Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nimbe Torres y Torres, PhD

  INCMNSZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The DP and placebo were packed in identical form and appearance. The treatment was provided in sealed boxes to the participants by an individual external to the study, but who performed the randomization. Furthermore, the researcher and the volunteer were unaware of the allocation of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nimbe Torres y Torres, PhD, Principal Investigator

Model Details: This study had two stages. In the first stage, subjects underwent dietary standardization with low saturated fat dietary treatments (LSFD) designed according to NCEP, ATP III criteria, and that provided the same amount of energy as that of the habitual diet of the volunteers, as assessed by 24-hour dietary recalls. In the second stage, subjects were randomly allocated to two different treatments, 1) LSFD plus placebo or, 2) LSFD plus dietary portfolio. Subjects were instructed to consume two packets of the corresponding treatment a day dissolved in 250-300 ml of water before breakfast and dinner for two consecutive months.

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: February 28, 2013
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share