Effect of Diabetes-Specific Nutrition Formula on the Metabolic Parameters of Filipino Adults with Metabolic Syndrome: a Randomized Crossover Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 35
- Primary Endpoint
- change from baseline to post-intervention in fasting blood sugar
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
change from baseline to post-intervention in fasting blood sugar
Time Frame: 3 months
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: fasting blood sugar, measured in mg/dL.
change from baseline to post-intervention in HDL cholesterol
Time Frame: 3 months
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: HDL cholesterol, measured in mg/dL.
change from baseline to post-intervention in serum triglycerides
Time Frame: 3 months
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: serum triglycerides, measured in mg/dL.
change from baseline to post-intervention in systolic blood pressure
Time Frame: 3 months
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: systolic blood pressure, measured in mmHg.
change from baseline to post-intervention in diastolic blood pressure
Time Frame: 3 months
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: diastolic blood pressure, measured in mmHg.
change from baseline to post-intervention in waist circumference
Time Frame: 3 months
The primary outcome measure of this study is the change from baseline to post-intervention in the following parameter of metabolic syndrome: waist circumference, measured in centimeters.
Secondary Outcomes
- change from baseline to post-intervention in glycosylated hemoglobin(3 months)
- change from baseline to post-intervention in LDL cholesterol(3 months)
- change from baseline to post-intervention in total cholesterol(3 months)
- change from baseline to post-intervention in body weight(3 months)
- change from baseline to post-intervention in body mass index(3 months)
- Adverse events related to the DSNF(3 months)
- Satiety scale(3 months)
- DSNF Compliance(3 months)
- Participants' perception of DSNF(3 months)
Investigators
Angelica Marie Real
Principal Investigator
St. Luke's Medical Center, Philippines