NCT06729008

Effect of Diabetes-Specific Nutrition Formula on the Metabolic Parameters of Filipino Adults with Metabolic Syndrome

Effect of Diabetes-Specific Nutrition Formula on the Metabolic Parameters of Filipino Adults with Metabolic Syndrome: a Randomized Crossover Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: St. Luke's Medical Center, Philippines · Academic / Other
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

INTRODUCTION: Metabolic syndrome, a cluster of metabolic abnormalities, is a growing global health concern, particularly in the Asia-Pacific region. The Philippines has seen a significant rise in metabolic syndrome prevalence, linked to lifestyle factors and socioeconomic changes. This condition increases the risk of serious health issues like type 2 diabetes, cardiovascular disease, and mortality. Lifestyle modifications, including dietary interventions, are crucial for managing metabolic syndrome. While dietary recommendations exist, practical challenges hinder their implementation. Diabetes-specific nutrition formulas (DSNFs) offer a convenient and effective solution, especially for individuals with limited cooking skills or knowledge. While DSNFs show promise in managing diabetes, their impact on metabolic syndrome remains unclear. This study aims to investigate the effects of DSNF on the metabolic parameters of Filipino adults with metabolic syndrome. METHODS: This open-label randomized crossover trial will be conducted at St. Luke's Medical Center Global City. Filipino adults aged 19-65 with metabolic syndrome will be recruited. Participants will be randomized to either a 90-day intervention phase (DSNF) with a 14-day washout period or a 90-day control phase. After the initial phase, participants will cross over to the alternate phase. The primary outcome will be the change in metabolic parameters in the metabolic syndrome criteria (fasting blood sugar, triglycerides, HDL cholesterol, blood pressure, and waist circumference). Secondary outcomes include changes in metabolic parameters related to the metabolic syndrome (glycosylated hemoglobin, total cholesterol, LDL cholesterol, body weight, BMI, body composition), and safety and tolerability of the treatments. Participants will be monitored through regular follow-up visits, daily food diaries, and subjective assessments. Data will be analyzed using appropriate statistical methods.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Diabetes-specific nutrition formula (DSNF)	The diabetes-specific nutrition formula to be used in this study will be Glucerna (Abbott Laboratories). It features an advanced blend of low-glycemic carbohydrates for steady energy release, a dual fiber blend to support digestive health, and a unique lipid blend free from trans fats, cholesterol, and low in saturated fat. Additionally, Glucerna is enriched with 4x more inositol and high levels of trivalent chromium, which contribute to maintaining normal blood glucose levels. It provides 28 essential vitamins and minerals, is low in lactose, and gluten-free, making it a suitable option for various dietary needs. 5 scoops will be mixed in 200 mL of water, and this amounts to 228 calories, with 30.01g of carbohydrates, 10.16g of protein, and 8.70g of fat. This will be given twice, as a breakfast replacement and an afternoon snack replacement.
OTHER	Medical Nutrition Therapy	Medical Nutrition Therapy is the standard of care for the management of metabolic syndrome

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-10-15
• Completion: 2025-11-01
• First posted: 2024-12-11
• Last updated: 2024-12-11