Uji Keamanan dan Efektivitas Shot Drink Sacha Inchi dan Black Garlic dalam Menurunkan Kolesterol, Tekanan Darah, dan Asam Urat

Abstract

Peningkatan prevalensi kolesterol tinggi, hipertensi, dan asam urat mendorong upaya preventif melalui konsumsi suplemen kesehatan. Penelitian ini bertujuan menganalisis keamanan dan pengaruh suplemen kesehatan shot drink berbasis black garlic dan sacha inchi terhadap kadar kolesterol, asam urat, dan tekanan darah. Metode yang digunakan adalah Randomized Controlled Trial (RCT) dengan pendekatan single-blind, parallel design, dan repeated measures, melalui pengujian efektivitas pada manusia terhadap 48 responden selama 14 hari yang terdiri dari kelompok intervensi dan plasebo. Hasil pengujian laboratorium menunjukkan produk memenuhi persyaratan keamanan dan mutu suplemen kesehatan sesuai ketentuan BPOM, meliputi batas cemaran mikroba, logam berat, dan kadar alkohol, dengan aktivitas antioksidan 21% pada konsentrasi 10.000 ppm serta kandungan asam lemak omega-3 sebesar 0,35%. Hasil pengujian efektivitas produk kepada manusia menunjukkan bahwa parameter kolesterol total dan asam urat mengalami penurunan yang signifikan terhadap waktu, namun seluruh parameter kesehatan yang diuji yaitu kolesterol total, tekanan darah, dan asam urat, tidak mengalami penurunan yang nyata dibandingkan kelompok plasebo. Produk shot drink telah memenuhi persyaratan keamanan dan mutu suplemen kesehatan berdasarkan pengujian laboratorium, tetapi belum terbukti efektif secara signifikan dalam menurunkan kadar kolesterol, tekanan darah, dan asam urat hanya dalam kurun waktu 14 hari.

The rising prevalence of high cholesterol, hypertension, and hyperuricemia has driven preventive efforts through the consumption of health supplements. This study aimed to analyze the safety and effects of a health supplement shot drink based on black garlic and sacha inchi on cholesterol, uric acid, and blood pressure levels. The method used was a Randomized Controlled Trial (RCT) with a single-blind, parallel design, and repeated measures approach, conducted through a direct trial on humans involving 48 respondents over 14 days which divided into intervention and placebo group. Laboratory testing results showed that the product met the safety and quality requirements for health supplements set by BPOM, including limits for microbial contamination, heavy metals, and alcohol content, with an antioxidant activity of 21% at a concentration of 10,000 ppm and an omega-3 fatty acid content of 0,35%. Testing on human results showed that total cholesterol and uric acid levels decreased significantly over time. However, all health parameters tested—total cholesterol, uric acid, and blood pressure—did not show a significant decrease when compared with the placebo group. Thus, the shot drink product has met the safety and quality requirements for health supplements based on laboratory testing, but based on clinical testing in humans, it has not yet been shown to be significantly effective in reducing cholesterol, uric acid, and blood pressure levels only for 14 days intervention duration.