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

NCT06729008 | Not Yet Recruiting

• 1 other identifier: CDTEDDSNF2025
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome; Diabetes-Specific Nutrition Formula; Philippines

Outcome Measures

Primary Outcomes (6)

• change from baseline to post-intervention in fasting blood sugar

  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.

  3 months

• change from baseline to post-intervention in HDL cholesterol

  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.

  3 months

• change from baseline to post-intervention in serum triglycerides

  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.

  3 months

• change from baseline to post-intervention in systolic blood pressure

  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.

  3 months

• change from baseline to post-intervention in diastolic blood pressure

  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.

  3 months

• change from baseline to post-intervention in waist circumference

  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.

  3 months

Secondary Outcomes (9)

• 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

Study Arms (2)

DSNF + MNT

EXPERIMENTAL

Dietary Supplement: Diabetes-specific nutrition formula (DSNF); Other: Medical Nutrition Therapy

MNT

ACTIVE COMPARATOR

Other: Medical Nutrition Therapy

Interventions

Diabetes-specific nutrition formula (DSNF) DIETARY_SUPPLEMENT

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.

DSNF + MNT

Medical Nutrition Therapy OTHER

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

Also known as: MNT

DSNF + MNT; MNT

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's Medical Center, Philippines: lead

Related Publications (4)

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Joy Arabelle C Fontanilla, Doctor of Medicine

  St. Luke's Medical Center, Philippines

  PRINCIPAL INVESTIGATOR

• Maria Patricia Deanna D Maningat, Doctor of Medicine

  St. Luke's Medical Center, Philippines

  PRINCIPAL INVESTIGATOR

• Sahra May O Paragas, Doctor of Medicine

  St. Luke's Medical Center, Philippines

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelica Marie P Real, Doctor of Medicine

CONTACT

+639190979650; ampreal@stlukes.com.ph

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: February 1, 2025
• Primary Completion: October 15, 2025
• Study Completion: November 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12