Efficacy and safety of Obex® in overweight and obese subjects: a randomised, double-blind, placebo-controlled clinical trial.
Background: Obex® may be helpful in reducing body weight and fat. The current study was carried out to evaluate the efficacy and safety of Obex® in the treatment of overweight and obese subjects. Methods: A double-blind, randomised, controlled phase III clinical trial was conducted involving 160 ove...
| Publicado en: | BMC Complementary Medicine & Therapies Vol. 23; no. 1; pp. 1 - 16 |
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| Autores principales: | , , , , , , , , , , , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
BioMed Central
2/20/2023
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=161991745&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 161991745 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 26627671 MFH8 jtl: BMC Complementary Medicine & Therapies issn: 26627671 maglogo: N pubinfo: dt: 2/20/2023 vid: 23 iid: 1 pid: 24147 pub: BioMed Central artinfo: ui: 161991745 161991745 161991745 10.1186/s12906-023-03847-7 161991745 ppf: 1 ppct: 15 formats: tig: atl: Efficacy and safety of Obex® in overweight and obese subjects: a randomised, double-blind, placebo-controlled clinical trial. aug: au: Cabrera-Rode, Eduardo Cubas-Dueñas, Ileana Acosta, Janet Rodríguez Hernández, Jeddú Cruz González, Ana Ibis Conesa Calero, Teresa M. González Domínguez, Yuri Arnold Rodríguez, José Hernández Rodríguez, Antonio D. Reyes Álvarez Álvarez, Aimee Valdés, Ragmila Echevarría Espinosa, Liudmila Jorge Belent, Onelia Torres Benavides, Zoila Bell Estévez, Elizabeth Senra Rodríguez, Yanet Abreu del Valle Rodríguez, Juana Juliá, Silvia Marín affil: Institute of Endocrinology, University of Medical Sciences of Havana, Zapata and D, Vedado 10400, Havana, Cuba sug: subj: Obesity Drug Therapy Patient Safety Dietary Supplements Treatment Outcomes Human Randomized Controlled Trials Double-Blind Studies Adult Middle Age Anthropometry Fasting Blood Glucose Analysis Insulin Resistance Descriptive Statistics Creatinine Life Style Changes Funding Source Adult: 19-44 years Middle Aged: 45-64 years ab: Background: Obex® may be helpful in reducing body weight and fat. The current study was carried out to evaluate the efficacy and safety of Obex® in the treatment of overweight and obese subjects. Methods: A double-blind, randomised, controlled phase III clinical trial was conducted involving 160 overweight and obese subjects (BMI ≥ 25.0 and < 40 kg/m2) aged 20 to 60 years, who received Obex® (n = 80) and placebo (n = 80) plus non-pharmacological treatment (physical activity and nutritional counseling). One sachet of Obex® or placebo were administered before the two main meals each day for 6 months. In addition to anthropometric measurements and blood pressure, fasting plasma and 2 h glucose levels during the oral glucose tolerance test, lipid profile, insulin, liver enzymes, creatinine, and uric acid (UA) were determined, insulin resistance (HOMA-IR) beta-cell function (HOMA-β) were assessed and insulin sensitivity (IS) was calculated with three indirect indexes. Results: After 3 months of Obex®, 48.3% of the participants (28/58) achieved complete success in reducing both weight and waist circumference by greater than or equal to 5% from baseline, as opposed to 26.0% (13/50) of individuals receiving placebo (p = 0.022). Compared to baseline, at 6 months no differences were found between the groups concerning anthropometric and biochemical measurements, except for high-density lipoprotein cholesterol (HDL-c) levels, which were higher in subjects receiving Obex® compared to those receiving placebo (p = 0.030). After 6 months of treatment, both groups showed reduced cholesterol and triglyceride levels (p < 0.012) compared to baseline value. However, only those intake Obex® showed reduced insulin concentrations and HOMA-IR, improved IS (p < 0.05), and decreased creatinine and UA levels (p < 0.005). Conclusions: The consumption of Obex® together with lifestyle changes increased HDL-c, contributed to a rapid reduction of weight and waist circumference, as well as improved insulin homeostasis, which did not occur in the placebo group, and appears to be safe as an adjunct at conventional obesity treatment. Trial registration: Clinical trial protocol was registered in the Cuban public registry of clinical trials under code RPCEC00000267 on 17/04/2018 and also registered in the international registry of clinical trials, ClinicalTrials.gov, under code: NCT03541005 on 30/05/2018. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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