Impact of High Protein and Low Carbohydrate Smoothie Drinks in Type-2 Diabetes Mellitus

Phase 2

Recruiting

• Conditions: Diabetes Mellitus, Type 2; clinical nutrition; diabetes; smoothie drink; meal replacement; medical food; obesity

• Registration Number: TCTR20201104006
• Lead Sponsor: Faculty of Medicine Siriraj Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-04
• Study Completion: 2021-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.people with type 2 diabetes mellitus or use blood glucose-lowering drugs more than 3 months
2.BMI > 25 kg/m^2
3.HbA1c 6.5 - 8.5
4.use stable level of blood glucose-lowering drugs and blood lipid-lowering drugs more than 3 months

Exclusion Criteria

1.pregnancy or breastfeeding
2.people with chronic diseases or tube feeding or dysphagia i.e. pneumonia
3.people with insulin injection or use GLP-1 analogues drugs or DPP-4 inhibitors drugs
4.people with history of bariatric surgery, gastroparesis, malabsorption
5.people with history of diseases that affect blood glucose/lipid control i.e. hyperthyroidism, endocrinology and kidney disorders
6.use long-term immunosuppressants
7.cancer patient

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline Glycemia at 240 minutes Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240 glucose (mg/dl),Change from baseline Insulin at 240 minutes Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240 insulin (μU/ml)

Secondary Outcome Measures

Name	Time	Method
Age Baseline years,Weight Baseline kg,็Height Baseline cm,Body Mass Index Baseline kg/m^2,Waist circumference Baseline cm,Blood pressure Baseline Systolic and Diastolic blood pressure (mmHg),Complete Blood Count (CBC) Baseline Red blood cells (RBC) [10^6 cells/ul], White blood cells (WBC) [10^3 cells/ul], Hemoglobin (HGB) [g/,glycosylated hemoglobin (HbA1C) Baseline percentage (%),liver aminotransferaces activity - Serum glutamate oxaloacetate transaminase (SGOT) Baseline Serum glutamate oxaloacetate transaminase (SGOT) [U/L],liver aminotransferaces activity - Serum glutamate pyruvate transaminase (SGPT) Baseline Serum glutamate pyruvate transaminase (SGPT) [U/L],lipid profiles concentration analysis Baseline Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-Cholesterol (mg/dl) and LDL-Cholesterol (mg/dl),Creatinine concentration analysis Baseline mg/dl