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

NCT ID: NCT04577274

Last Updated: 2022-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-04

Study Completion Date

2021-05-31

Brief Summary

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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

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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).

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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smoothie with regular formulas (SM)

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.

Group Type EXPERIMENTAL

smoothie with regular formulas (SM)

Intervention Type 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)

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.

Group Type EXPERIMENTAL

smoothie with low carbohydrate formulas (SMLS)

Intervention Type 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)

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

Group Type ACTIVE_COMPARATOR

conventional diabetic enteral drinks (Glucerna)

Intervention Type 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.

Interventions

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smoothie with regular formulas (SM)

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.

Intervention Type DIETARY_SUPPLEMENT

smoothie with low carbohydrate formulas (SMLS)

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.

Intervention Type DIETARY_SUPPLEMENT

conventional diabetic enteral drinks (Glucerna)

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Council of Thailand

OTHER_GOV

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Korapat Mayurasakorn, MD.

Role: PRINCIPAL_INVESTIGATOR

Doctor in Family Medicine

Locations

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Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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814/2562 (IRB3)

Identifier Type: -

Identifier Source: org_study_id

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