Clinical trial NCT06729008: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
Diabetes-Specific Nutrition Formula
Philippines
Lead sponsor: St. Luke's Medical Center, Philippines
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. An employee of St. Luke's Medical Center Global City for at least 1 year
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:

1. Serious illness requiring medical attention within past year (active malignancy, HIV/AIDS, cardiovascular, respiratory, renal, or hepatic diseases)
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

Primary outcomes:
measure: change from baseline to post-intervention in fasting blood sugar
timeFrame: 3 months
measure: change from baseline to post-intervention in HDL cholesterol
timeFrame: 3 months
measure: change from baseline to post-intervention in serum triglycerides
timeFrame: 3 months
measure: change from baseline to post-intervention in systolic blood pressure
timeFrame: 3 months
measure: change from baseline to post-intervention in diastolic blood pressure
timeFrame: 3 months
measure: change from baseline to post-intervention in waist circumference
timeFrame: 3 months
Secondary outcomes:
measure: change from baseline to post-intervention in glycosylated hemoglobin
timeFrame: 3 months
measure: change from baseline to post-intervention in LDL cholesterol
timeFrame: 3 months
measure: change from baseline to post-intervention in total cholesterol
timeFrame: 3 months
measure: change from baseline to post-intervention in body weight
timeFrame: 3 months
measure: change from baseline to post-intervention in body mass index
timeFrame: 3 months
measure: Adverse events related to the DSNF
timeFrame: 3 months
measure: Satiety scale
timeFrame: 3 months
measure: DSNF Compliance
timeFrame: 3 months
measure: Participants' perception of DSNF
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: St. Luke's Medical Center, Philippines
name: Joy Arabelle C Fontanilla, Doctor of Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Medical Center, Philippines
name: Maria Patricia Deanna D Maningat, Doctor of Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Medical Center, Philippines
name: Sahra May O Paragas, Doctor of Medicine
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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.
citation: 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.