Effect of Diabetes-Specific Nutrition Formula on the Metabolic Parameters of Filipino Adults with Metabolic Syndrome
NCT ID: NCT06729008
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
35 participants
INTERVENTIONAL
2025-02-01
2025-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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DSNF + MNT
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.
Medical Nutrition Therapy
Medical Nutrition Therapy is the standard of care for the management of metabolic syndrome
MNT
Medical Nutrition Therapy
Medical Nutrition Therapy is the standard of care for the management of metabolic syndrome
Interventions
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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.
Medical Nutrition Therapy
Medical Nutrition Therapy is the standard of care for the management of metabolic syndrome
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Of Filipino descent
3. Aged 19-65 years
4. 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)
5. BMI of 23 kg/m2 or more
6. Willingness to adhere to study protocol
Exclusion Criteria
2. Use of medications affecting plasma glucose within 3 months (corticosteroids, diuretics, beta-blockers, antipsychotics, and HIV medications)
3. Insulin use
4. Severe hypoglycemia or hyperglycemia requiring hospitalization within past year
5. Surgery or hospitalization within past 2-3 months
6. Anemia and/or blood transfusion within the last 3 months
7. History of gastrointestinal disease/surgery affecting product consumption/absorption (inflammatory bowel disease/bowel resection, another specifies gastroparesis, malabsorption, bariatric surgery, short bowel syndrome)
8. Use of other diabetes-specific formulas prior to this study
9. Use of nutritional food supplements or multivitamin supplements (specifically calcium/vitamin D supplements and B complex syrups) within 15 days before study initiation
10. Psychiatric disorder impairing study adherence (eating disorders, severe dementia, delirium, significant neurological/psychiatric disorder)
11. Pregnancy/ lactation
12. 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.)
13. Weight loss/gain ≥ 5 kg within 6 weeks of starting the study
14. Planning to start any form of calorie-restricted diet
15. Alcoholism/substance use
19 Years
60 Years
ALL
No
Sponsors
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St. Luke's Medical Center, Philippines
OTHER
Responsible Party
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Angelica Marie Real
Principal Investigator
Principal Investigators
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Joy Arabelle C Fontanilla, Doctor of Medicine
Role: PRINCIPAL_INVESTIGATOR
St. Luke's Medical Center, Philippines
Maria Patricia Deanna D Maningat, Doctor of Medicine
Role: PRINCIPAL_INVESTIGATOR
St. Luke's Medical Center, Philippines
Sahra May O Paragas, Doctor of Medicine
Role: PRINCIPAL_INVESTIGATOR
St. Luke's Medical Center, Philippines
Central Contacts
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Angelica Marie P Real, Doctor of Medicine
Role: CONTACT
Phone: +639190979650
Email: [email protected]
References
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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.
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.
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.
Other Identifiers
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CDTEDDSNF2025
Identifier Type: -
Identifier Source: org_study_id