Effect of Dietary Intervention on LDL-C and Lipoprotein Subclasses Distribution in Patients With Hypercholesterolemia
Condition: Hypercholesterolemia; Disease; Dyslipidemias
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional

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.
    

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.
    

Intervention name(s): Placebo; Dietary portfolio
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A mixture of maltodextrins and calcium caseinate divided into 30g individual packets.; A mixture of functional foods divided into 30g individual packets.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hypercholesterolemia; dietary portfolio; soy protein; LDL-C; lipoprotein subclasses; nopal; chia seed; functional foods