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Abstract
Hyperlipidemia is one of the leading causes of death and requires lipid-lowering treatment to reduce morbidity and mortality. Effective and safe alternative and adjunctive therapies could be beneficial for patients with hyperlipidemia. To assess the effect of a fiber-multivitamin combination product on the lipid parameters low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), total cholesterol (TC), triglyceride (TG), and apolipoprotein B (Apo B) in patients with hypercholesterolemia, we conducted a double-blind, randomized, parallel-group study. Forty-one out of 50 randomized hypercholesterolemic participants recruited between August 2016 and March 2018 completed the trial. The participants were assigned to receive either test product (treatment group, n = 20) or placebo (placebo group, n = 21) for 4 weeks following a 6-week dietary intervention (based on education from a dietitian) run-in period. The primary outcome was LDL-c levels and the secondary outcomes were HDL-c, TC, TG, and Apo B levels. All of the outcomes were measured at baseline and week 4 after the completion of run-in period. Participants in both groups had similar LDL-c levels (142 ± 15.7 vs. 143 ± 19.3 mg/dL). After 4 weeks of exposure to test product, participants in the treatment group demonstrated a 17.25 ± 22.26 reduction in LDL-c (p < .05 vs. placebo). This improvement in LDL-c was accompanied by amelioration in TC and Apo B levels, without any detrimental effects on HDL and TG concentration. Results of the present study suggest that fiber-vitamin combination has potential to be used as an adjunct therapy for the management of hypercholesterolemia.
Acknowledgments
The authors thank the following parties for their contributions to the success of this trial. Participating Centers: Hasan Sadikin General Hospital, Bandung; Kimia Farma 167 Clinic, Cimahi, Bandung; Insan Sehat Clinic Baleendah, Bandung; Indonesia. Research Coordinators and Research Assistants: Nazhifa Ufamy MD MSc1,2, Irianti Bahana Maulida Reyaan MSc1, Siti Farah Rahmawati MSc1, Dhyan Kusuma Ayuningtyas MSc1. The Research Coordinator and Research Assistants screened candidates, obtained consent, randomized study participants, and collected data. Facility Coordinator at Hasan Sadikin General Hospital: Toni M. Aprami MD Sp.PD Sp.JP(K) MMRS3,4 [Internist, Cardiologist (Consultant), Master of Hospital Management]. The Facility Coordinator prepared pertinent facilities for the implementation of the clinical trial at Hasan Sadikin General Hospital as the main center of study. Nutrition Counselor: Yesi Herawati SGz RD5 [Bachelor in Nutrition and Dietetics, Registered Dietitian]. The Nutrition Counselor conducted dietary intervention for study participants. Chemical Analysts: Hijriyanti Amd AK6 [Associate to Health Analyst], Nita Herlina SST6 [Associate in Applied Science]. The Chemical Analysts took blood samples from study participants for hematology analyses. Adjudicators: Kusnandar Anggadiredja MSc PhD1, Lia Amalia MSc PhD1, Neng Fisheri Kurniati MSc PhD1. Primary outcomes were adjudicated for presence and severity. Data Entry and Statistical Analysis: Neng Fisheri Kurniati MSc PhD1, Irianti Bahana Maulida Reyaan MSc1. Data Entry and Statistical Analysis personnel recorded study participants’ data, reconciled raw and recorded data, and conducted statistical analysis. Data Access and Responsibility: The principal investigator, Kusnandar Anggadiredja, had full access to all data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Notes
Declaration of interest
The authors declare no conflicts of interest. The authors alone are responsible for the content and writing of the article.
About the authors
Kusnandar Anggadiredja, MSc, PhD, Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut Teknologi Bandung (ITB), Bandung, Indonesia. Research interests are KA: Neuropharmacology, LA: Clinical and community pharmacy, NFK: Pharmacology of the cardiovascular and endocrine systems, IBMR: Clinical and community pharmacy.
Nazhifa Ufamy, MD, MSc, Faculty of Medicine, Jenderal Achmad Yani University, Bandung, Indonesia. Research interest is Community health.
Lia Amalia, MSc, PhD, Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut Teknologi Bandung (ITB), Bandung, Indonesia. Research interests are KA: Neuropharmacology, LA: Clinical and community pharmacy, NFK: Pharmacology of the cardiovascular and endocrine systems, IBMR: Clinical and community pharmacy.
Neng Fisheri Kurniati, MSc, PhD, Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut Teknologi Bandung (ITB), Bandung, Indonesia. Research interests are KA: Neuropharmacology, LA: Clinical and community pharmacy, NFK: Pharmacology of the cardiovascular and endocrine systems, IBMR: Clinical and community pharmacy.
Irianti Bahana Maulida Reyaan, MSc, Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut Teknologi Bandung (ITB), Bandung, Indonesia. Research interests are KA: Neuropharmacology, LA: Clinical and community pharmacy, NFK: Pharmacology of the cardiovascular and endocrine systems, IBMR: Clinical and community pharmacy
Notes
1 Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut Teknologi Bandung (ITB), Bandung, Indonesia.
2 Faculty of Medicine, Jenderal Achmad Yani University, Bandung, Indonesia.
3 Cardiology and Vascular Medicine Department, Faculty of Medicine, Padjadjaran University, Bandung, Indonesia.
4 Integrated Cardiology Service Department, Hasan Sadikin General Hospital, Bandung, Indonesia.
5 Clinical Nutrition Department, Hasan Sadikin General Hospital, Bandung, Indonesia.
6 Clinical Pathology Department, Hasan Sadikin General Hospital, Bandung, Indonesia.