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

November 4, 2019 updated by: Nimbe Torres y Torres, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo (P)
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
A mixture of maltodextrins and calcium caseinate divided into 30g individual packets.
Experimental: Dietary Portfolio (DP)
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
A mixture of functional foods divided into 30g individual packets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low density lipoprotein- cholesterol (LDL-C)
Time Frame: Change in total LDL-C after 2.5 months of treatment
Plasma total LDL-C (mg/dl)
Change in total LDL-C after 2.5 months of treatment
Lipoprotein subclasses
Time Frame: Change in small, medium and large LDL, HDL and VLDL lipoprotein subclasses after 2.5 months of treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total cholesterol
Time Frame: Change in total cholesterol after 2.5 months of treatment
Plasma total cholesterol (mg/dL)
Change in total cholesterol after 2.5 months of treatment
Triglycerides
Time Frame: Change in triglycerides after 2.5 months of treatment
Plasma triglycerides (mg/dL)
Change in triglycerides after 2.5 months of treatment
High density lipoprotein cholesterol (HDL-C)
Time Frame: Change after 2.5 months of treatment
Plasma HDL cholesterol (mg/dL)
Change after 2.5 months of treatment
Apolipoprotein B
Time Frame: Change after 2.5 months of treatment
Change in apolipoprotein B in
Change after 2.5 months of treatment
Apolipoprotein A
Time Frame: Change after 2.5 months of treatment
Change in apolipoprotein A in plasma
Change after 2.5 months of treatment
Total/ high density lipoprotein cholesterol (HDL-C) ratio
Time Frame: Change after 2.5 months of treatment
Change in total/ high density lipoprotein cholesterol (HDL-C) ratio
Change after 2.5 months of treatment
Apolipoprotein B/Apolipoprotein A ratio
Time Frame: Change after 2.5 months of treatment
Change in Apolipoprotein B / Apolipoprotein A ratio
Change after 2.5 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Principal Investigator: Nimbe Torres y Torres, PhD, INCMNSZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2013

Primary Completion (Actual)

December 18, 2018

Study Completion (Actual)

December 18, 2018

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (Actual)

November 4, 2019

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 706

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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