Pere Domingo1, Irene Fernández2, José Miguel Gallego-Escuredo3, Ferran Torres4, Ma Del Mar Gutierrez2, Ma Gracia Mateo2, Joan Villarroya5, Marta Giralt3, Francesc Vidal6, Francesc Villarroya3, Joan Carles Domingo3. 1. Infectious Diseases Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Infectious Diseases Department, Hospital Arnau de Vilanova, Universitat de Lleida, Institut de Recerca Biomèdica de LLeida (IRBLleida), Lleida, Spain. Electronic address: pdomingo@santpau.cat. 2. Infectious Diseases Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. 3. Department of Biochemistry and Molecular Biology, Institute of Biomedicine (IBUB), University of Barcelona, Barcelona, Spain; CIBER Fisiopatologia de la Obesidad y Nutrición, Barcelona, Spain. 4. Biostatistics and Data Management Core Facility, IDIBAPS, Hospital Clinic, Barcelona, Spain; Biostatistics Unit, School of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain. 5. Infectious Diseases Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Department of Biochemistry and Molecular Biology, Institute of Biomedicine (IBUB), University of Barcelona, Barcelona, Spain; CIBER Fisiopatologia de la Obesidad y Nutrición, Barcelona, Spain. 6. Infectious Diseases Unit, Department of Internal Medicine, Hospital Universitari Joan XXIII, IISPV, Universitat Rovira i Virgili, Tarragona, Spain.
Abstract
BACKGROUND:Hypertriglyceridemia is common in HIV-infected patients. Polyunsaturated fatty acids reduce fasting serum triglyceride (TG) levels in HIV-infected patients. It is not known whether docosahexanoic acid (DHA) supplementation can reduce hypertriglyceridemia and modify fat distribution in HIV-infected patients. METHODS: We conducted a randomized, double-blind, placebo-controlled trial with 84 antiretroviral-treated patients who had fasting TG levels from 2.26 to 5.65 mmol/l and were randomized to receive DHA or placebo for 48 weeks. TG levels were assessed at baseline, week 4 and every 12 weeks. Body composition was assessed at baseline and at week 48. Registered under ClinicalTrials.gov Identifier no. NCT02005900. RESULTS: Patients receiving DHA had a 43.9% median decline in fasting TG levels at week 4 (IQR: -31% to -56%), compared with -2.9% (-18.6% to 16.5%) in the placebo group (P < 0.0001). DHA levels and decrease in TG at week 4 in the DHA arm correlated significantly (r = 0.7110, P < 0.0001). The median reduction in TG levels in the DHA arm was -43.7% (-32.4% to -57.5%), and in the placebo arm +2.9% (-21.3% to +30.1%) at week 12. The difference remained statistically significant at week 48 (P = 0.0253). LDL cholesterol levels significantly increased at week 4 by 7.1% (IQR: -4.8% to +35.3%) in the DHA arm but not in the placebo group. No significant changes were observed in HDL cholesterol, insulin, and HOMA-IR during the study. Limb fat significantly increased in both arms, without statistically significant differences between groups (P = 0.3889). DHA was well tolerated; only 3 patients experienced treatment-limiting toxicity. CONCLUSIONS:Supplementation with DHA reduced fasting TG levels in antiretroviral-treated HIV-infected patients with mild hypertriglyceridemia. DHA was well tolerated with minor GI symptoms. Peripheral fat significantly increased in the DHA group but did not increase significantly compared with placebo.
RCT Entities:
BACKGROUND:Hypertriglyceridemia is common in HIV-infectedpatients. Polyunsaturated fatty acids reduce fasting serum triglyceride (TG) levels in HIV-infectedpatients. It is not known whether docosahexanoic acid (DHA) supplementation can reduce hypertriglyceridemia and modify fat distribution in HIV-infectedpatients. METHODS: We conducted a randomized, double-blind, placebo-controlled trial with 84 antiretroviral-treated patients who had fasting TG levels from 2.26 to 5.65 mmol/l and were randomized to receive DHA or placebo for 48 weeks. TG levels were assessed at baseline, week 4 and every 12 weeks. Body composition was assessed at baseline and at week 48. Registered under ClinicalTrials.gov Identifier no. NCT02005900. RESULTS:Patients receiving DHA had a 43.9% median decline in fasting TG levels at week 4 (IQR: -31% to -56%), compared with -2.9% (-18.6% to 16.5%) in the placebo group (P < 0.0001). DHA levels and decrease in TG at week 4 in the DHA arm correlated significantly (r = 0.7110, P < 0.0001). The median reduction in TG levels in the DHA arm was -43.7% (-32.4% to -57.5%), and in the placebo arm +2.9% (-21.3% to +30.1%) at week 12. The difference remained statistically significant at week 48 (P = 0.0253). LDL cholesterol levels significantly increased at week 4 by 7.1% (IQR: -4.8% to +35.3%) in the DHA arm but not in the placebo group. No significant changes were observed in HDL cholesterol, insulin, and HOMA-IR during the study. Limb fat significantly increased in both arms, without statistically significant differences between groups (P = 0.3889). DHA was well tolerated; only 3 patients experienced treatment-limiting toxicity. CONCLUSIONS: Supplementation with DHA reduced fasting TG levels in antiretroviral-treated HIV-infectedpatients with mild hypertriglyceridemia. DHA was well tolerated with minor GI symptoms. Peripheral fat significantly increased in the DHA group but did not increase significantly compared with placebo.
Authors: Lydia de Salazar; Carlos Contreras; Antonio Torregrosa-García; Antonio J Luque-Rubia; Vicente Ávila-Gandía; Joan Carles Domingo; Francisco Javier López-Román Journal: Antioxidants (Basel) Date: 2020-11-18
Authors: Dominique Turck; Jacqueline Castenmiller; Stefaan De Henauw; Karen Ildico Hirsch-Ernst; John Kearney; Alexandre Maciuk; Inge Mangelsdorf; Harry J McArdle; Androniki Naska; Carmen Pelaez; Kristina Pentieva; Alfonso Siani; Frank Thies; Sophia Tsabouri; Marco Vinceti; Francesco Cubadda; Thomas Frenzel; Marina Heinonen; Rosangela Marchelli; Monika Neuhäuser-Berthold; Morten Poulsen; Miguel Prieto Maradona; Josef Rudolf Schlatter; Henk van Loveren; Emanuela Turla; Helle Katrine Knutsen Journal: EFSA J Date: 2021-01-19
Authors: Pere Domingo; María Gracia Mateo; Joan Villarroya; Rubén Cereijo; Ferran Torres; Joan C Domingo; Laura Campderrós; José M Gallego-Escuredo; María Del Mar Gutierrez; Isabel Mur; Noemí Corbacho; Francesc Vidal; Francesc Villarroya; Marta Giralt Journal: J Clin Med Date: 2022-01-22 Impact factor: 4.241