Clinical trial NCT04577274: Impact of High Protein and Low Carbohydrate Smoothie Drinks in Type-2 Diabetes Mellitus
Official title: Impact of High Protein and Low Carbohydrate Smoothie Drinks Versus Diabetes-specific Nutritional Formulas on Postprandial Glucose Homeostasis in Type-2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: clinical nutrition
smoothie drink
meal replacement
medical food
diabetes
obesity
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
First posted: 2020-10-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We compared between a regular high protein or a high protein and low carbohydrate smoothie drinks with conventional diabetic enteral drinks (Glucerna) on glucose homeostasis, insulin and lipid metabolism in type 2 diabetic and obese individuals.

Detailed description: We aimed to determine the effect of high protein and low carbohydrate smoothie drinks on glucose homeostasis, insulin and lipid metabolism in type 2 diabetic and obese individuals. We compared between a regular high protein or a high protein and low carbohydrate smoothie drinks with conventional diabetic enteral drinks (Glucerna). A crossover design study was done in 60 diabetic participants. Participants consumed 300 kilocalories of each drink at a time with one week wash out period between drinks and glucose response curves at baseline, 30, 60, 90, 120, 180 and 240 minutes were monitored and compared. The products were formulated to supply 1 kilocalorie/milliliter (kcal/ml). Dietary compositions in regular formulas (smoothie, SM) were 30-40% carbohydrate, 20-30% protein and 30-50% fat. While in smoothie with low carbohydrate formulas (SMLS), they were 25-35% carbohydrate, 25-30% protein and 35-55% fat vs. a control formula (Glucerna).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Glycemia at 240 minutes
timeFrame: Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240
measure: Change from baseline Insulin at 240 minutes
timeFrame: Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Body Mass Index
timeFrame: Baseline
measure: Waist circumference
timeFrame: Baseline
measure: Blood pressure
timeFrame: Baseline
measure: Complete Blood Count (CBC)
timeFrame: Baseline
measure: glycosylated hemoglobin (HbA1C)
timeFrame: Baseline
measure: liver aminotransferaces activity - Serum glutamate oxaloacetate transaminase (SGOT)
timeFrame: Baseline
measure: liver aminotransferaces activity - Serum glutamate pyruvate transaminase (SGPT)
timeFrame: Baseline
measure: lipid profiles concentration analysis
timeFrame: Baseline
measure: Creatinine concentration analysis
timeFrame: Baseline
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Doctor in Family Medicine
name: Korapat Mayurasakorn, MD.
role: PRINCIPAL_INVESTIGATOR
References: