NCT04577274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

November 4, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

April 8, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

October 1, 2020

Last Update Submit

April 7, 2022

Conditions

Diabetes Mellitus, Type 2

Keywords

clinical nutritionsmoothie drinkmeal replacementmedical fooddiabetesobesity

Outcome Measures

Primary Outcomes (2)

  • Change from baseline Glycemia at 240 minutes

    glucose (mg/dl)

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

  • Change from baseline Insulin at 240 minutes

    insulin (μU/ml)

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

Secondary Outcomes (12)

  • Age

    Baseline

  • Weight

    Baseline

  • Height

    Baseline

  • Body Mass Index

    Baseline

  • Waist circumference

    Baseline

  • +7 more secondary outcomes

Study Arms (3)

smoothie with regular formulas (SM)

EXPERIMENTAL

Participants were given 300 kcal smoothie with regular formulas within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes.

Dietary Supplement: smoothie with regular formulas (SM)

smoothie with low carbohydrate formulas (SMLS)

EXPERIMENTAL

Participants were given 300 kcal smoothie with low carbohydrate formulas within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes.

Dietary Supplement: smoothie with low carbohydrate formulas (SMLS)

conventional diabetic enteral drinks (Glucerna)

ACTIVE COMPARATOR

Participants were given 300 kcal Glucerna within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes.

Dietary Supplement: conventional diabetic enteral drinks (Glucerna)

Interventions

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 regular formulas (SM)
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.

smoothie with low carbohydrate formulas (SMLS)
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.

conventional diabetic enteral drinks (Glucerna)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusObesity

Interventions

Glucerna

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Korapat Mayurasakorn, MD.

    Doctor in Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2020

First Posted

October 6, 2020

Study Start

November 4, 2020

Primary Completion

March 31, 2021

Study Completion

May 31, 2021

Last Updated

April 8, 2022

Record last verified: 2022-04

Locations

TH(1)