Effect of Dietary Intervention on LDL-C and Lipoprotein Subclasses Distribution in Patients With Hypercholesterolemia
Effect of Dietary Intervention on LDL-C Levels and Lipoprotein Subclasses Distribution in Patients With Hypercholesterolemia
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Placebo-Komparator: 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.
|
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.
|
A mixture of functional foods divided into 30g individual packets.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Low density lipoprotein- cholesterol (LDL-C)
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Total cholesterol
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: Change after 2.5 months of treatment
|
Plasma HDL cholesterol (mg/dL)
|
Change after 2.5 months of treatment
|
|
Apolipoprotein B
Zeitfenster: Change after 2.5 months of treatment
|
Change in apolipoprotein B in
|
Change after 2.5 months of treatment
|
|
Apolipoprotein A
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Change after 2.5 months of treatment
|
Change in Apolipoprotein B / Apolipoprotein A ratio
|
Change after 2.5 months of treatment
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Nimbe Torres y Torres, PhD, INCMNSZ
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
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Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
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Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
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Andere Studien-ID-Nummern
- 706
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