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Completed

NCT Number: NCT04577274

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

smoothie with regular formulas (SM)

Dietary Supplement

Participants were given 300 kcal of smoothie drink within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. Participants have one week wash out period before try-out other formulas.

smoothie with low carbohydrate formulas (SMLS)

Dietary Supplement

Participants were given 300 kcal of smoothie drink within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. Participants have one week wash out period before try-out other formulas.

conventional diabetic enteral drinks (Glucerna)

Dietary Supplement

Participants were given 300 kcal of smoothie drink within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. Participants have one week wash out period before try-out other formulas.

Primary outcomes

  1. Change from baseline Glycemia at 240 minutes

    Time frame: Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240

    glucose (mg/dl)

  2. Change from baseline Insulin at 240 minutes

    Time frame: Minutes after intake of each smoothie formula: 0, 30, 60, 90, 120, 180, 240

    insulin (μU/ml)

Secondary outcomes

  1. Age

    Time frame: Baseline

    years

  2. Weight

    Time frame: Baseline

    kg

  3. Height

    Time frame: Baseline

    cm

  4. Body Mass Index

    Time frame: Baseline

    kg/m^2

  5. Waist circumference

    Time frame: Baseline

    cm

  6. Blood pressure

    Time frame: Baseline

    Systolic and Diastolic blood pressure (mmHg)

  7. Complete Blood Count (CBC)

    Time frame: Baseline

    Red blood cells (RBC) [10^6 cells/ul], White blood cells (WBC) [10^3 cells/ul], Hemoglobin (HGB) [g/dL], Hematocrit (HCT) [%]

  8. glycosylated hemoglobin (HbA1C)

    Time frame: Baseline

    percentage (%)

  9. liver aminotransferaces activity - Serum glutamate oxaloacetate transaminase (SGOT)

    Time frame: Baseline

    Serum glutamate oxaloacetate transaminase (SGOT) [U/L]

  10. liver aminotransferaces activity - Serum glutamate pyruvate transaminase (SGPT)

    Time frame: Baseline

    Serum glutamate pyruvate transaminase (SGPT) [U/L]

  11. lipid profiles concentration analysis

    Time frame: Baseline

    Triglycerides (mg/dl), Cholesterol (mg/dl), HDL-Cholesterol (mg/dl) and LDL-Cholesterol (mg/dl)

  12. Creatinine concentration analysis

    Time frame: Baseline

    mg/dl

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • National Research Council of Thailand

Registry information

Official study title

Impact of High Protein and Low Carbohydrate Smoothie Drinks Versus Diabetes-specific Nutritional Formulas on Postprandial Glucose Homeostasis in Type-2 Diabetes Mellitus

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 6, 2020
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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