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

Official title

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

Overview

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.

Interventions

• 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 es
• Other Medical Nutrition Therapy
  Medical Nutrition Therapy is the standard of care for the management of metabolic syndrome

Primary outcome measures

• change from baseline to post-intervention in fasting blood sugar [Time frame: 3 months]
• change from baseline to post-intervention in HDL cholesterol [Time frame: 3 months]
• change from baseline to post-intervention in serum triglycerides [Time frame: 3 months]
• change from baseline to post-intervention in systolic blood pressure [Time frame: 3 months]
• change from baseline to post-intervention in diastolic blood pressure [Time frame: 3 months]
• change from baseline to post-intervention in waist circumference [Time frame: 3 months]

Secondary outcome measures (9)

• change from baseline to post-intervention in glycosylated hemoglobin [Time frame: 3 months]
• change from baseline to post-intervention in LDL cholesterol [Time frame: 3 months]
• change from baseline to post-intervention in total cholesterol [Time frame: 3 months]
• change from baseline to post-intervention in body weight [Time frame: 3 months]
• change from baseline to post-intervention in body mass index [Time frame: 3 months]
• Adverse events related to the DSNF [Time frame: 3 months]
• Satiety scale [Time frame: 3 months]
• DSNF Compliance [Time frame: 3 months]
• Participants' perception of DSNF [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

• An employee of St. Luke's Medical Center Global City for at least 1 year
• Of Filipino descent
• Aged 19-65 years
• Diagnosed with metabolic syndrome74 for at least 3 months, one of the criteria must include central obesity (WC of ≥90cm in Asian men, ≥80cm in Asian women)

a. If being treated with a stable dose of medications for metabolic syndrome for ≥ 1 month, must only be among the following: i. Oral hypoglycemic agents (OHAs) (drugs permitted include Metformin, Sulfonylureas, Thiazolidinedione, Dipeptidyl Peptidase-IV Inhibitors, Glucagon-Like Peptide-1 Agonists) ii. Anti-hypertensive medications (drugs permitted include Angiotensin-converting enzyme (ACE) inhibitors, Angiotensin II receptor blockers, Calcium Channel Blockers) iii. Medications treating dyslipidemia (drugs permitted include Statins, Fibrates, Ezetimibe)

• BMI of 23 kg/m2 or more
• Willingness to adhere to study protocol

Exclusion criteria

• Serious illness requiring medical attention within past year (active malignancy, HIV/AIDS, cardiovascular, respiratory, renal, or hepatic diseases)
• Use of medications affecting plasma glucose within 3 months (corticosteroids, diuretics, beta-blockers, antipsychotics, and HIV medications)
• Insulin use
• Severe hypoglycemia or hyperglycemia requiring hospitalization within past year
• Surgery or hospitalization within past 2-3 months
• Anemia and/or blood transfusion within the last 3 months
• History of gastrointestinal disease/surgery affecting product consumption/absorption (inflammatory bowel disease/bowel resection, another specifies gastroparesis, malabsorption, bariatric surgery, short bowel syndrome)
• Use of other diabetes-specific formulas prior to this study
• Use of nutritional food supplements or multivitamin supplements (specifically calcium/vitamin D supplements and B complex syrups) within 15 days before study initiation
• Psychiatric disorder impairing study adherence (eating disorders, severe dementia, delirium, significant neurological/psychiatric disorder)
• Pregnancy/ lactation
• Allergy/intolerance to study product components (INGREDIENTS : Maltodextrin, VEGETABLE OIL (high oleic sunflower oil, soy oil), calcium caseinate, sucromalt, isolated soy protein, maltitol, milk protein concentrate (cow's milk), MINERALS (potassium chloride, magnesium sulfate, calcium carbonate, potassium citrate, sodium phosphate, sodium chloride, magnesium phosphate, sodium citrate, potassium hydroxide, zinc sulfate, ferrous sulfate, manganese sulfate, copper sulfate, chromium chloride, potassium iodide, sodium molybdate, sodium selenite), fructose, fructo-oligosaccharides, isomaltulose, myo-inositol, oat fiber, flavoring, emulsifier (carboxymethyl cellulose), choline chloride, emulsifier (soy lecithin), stabiliser (xanthan gum), VITAMINS (ascorbyl palmitate, ascorbic acid, Vitamin E, niacinamide, calcium d-pantothenate, pyridoxine hydrochloride, thiamin chloride hydrochloride, riboflavin, Vitamin A palmitate, folic acid, phylloquinone, d-biotin, cholecalciferol, cyanocobalamin), taurine, L-carnitine, mixed tocopherols. Contains permitted flavouring substance. Contains stabilisers and emulsifiers as permitted food conditioners.)
• Weight loss/gain ≥ 5 kg within 6 weeks of starting the study
• Planning to start any form of calorie-restricted diet
• Alcoholism/substance use

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Zimmet P, Alberti KG, Shaw J. Global and societal implications of the diabetes epidemic. Nature. 2001 Dec 13;414(6865):782-7. doi: 10.1038/414782a. PMID 11742409
• International Diabetes Federation. The IDF consensus worldwide definition of the metabolic syndrome. Accessed November 7, 2024. https://idf.org/media/uploads/2023/05/attachments-30.pdf
• Amihaesei IC, Chelaru L. Metabolic syndrome a widespread threatening condition; risk factors, diagnostic criteria, therapeutic options, prevention and controversies: an overview. Rev Med Chir Soc Med Nat Iasi. 2014 Oct-Dec;118(4):896-900. PMID 25581945
• Ranasinghe P, Mathangasinghe Y, Jayawardena R, Hills AP, Misra A. Prevalence and trends of metabolic syndrome among adults in the asia-pacific region: a systematic review. BMC Public Health. 2017 Jan 21;17(1):101. doi: 10.1186/s12889-017-4041-1. PMID 28109251

Identifiers

NCT: NCT06729008 · CDTEDDSNF2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗