ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000201370

Ethics application status

Approved

Date submitted

19/01/2017

Date registered

6/02/2017

Date last updated

4/06/2019

Date data sharing statement initially provided

11/02/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Comparison of effects on blood glucose and lipid levels upon consumption of different types of coffee

Scientific title

Comparison of effects on blood glucose and lipid levels upon consumption of different types of coffee in healthy adults

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Postprandial blood glucose and lipid levels.

Condition category

Condition code

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The following test drinks are tested: espresso-, instant, boiled and decaffeinated coffee, both with and without sugar and milk added, as well as water and sugar-sweetened milk. The details of the test drinks are listed below:

Espresso-coffee: 35ml of the beverage is made from 7g of grounded coffee powder using an espresso machine (Delonghi 680). Caffeine content in one serve of espresso drink is 115mg.

Instant coffee: made by adding 2g of instant coffee powder into 140ml of near-boiling water. Caffeine content in one serve of instant coffee drink is 110mg.

Boiled coffee: made by adding 9g of grounded coffee powder into 175ml boiled water. Simmer for 10 minutes and cool in room temperature for 3 minutes. 150ml of the coffee beverage is served. Caffeine content in one serve of boiled coffee drink is 170mg.

Decaffeinated coffee: made by adding 2g of decaffeinated coffee powder into 140ml of near-boiling water. Caffeine content in one serve of decaffeinated coffee drink is 3mg.

All beverages listed above are tested in two versions: one with 50g low-fat cow's milk and 7.5 g white sugar added, while the other with nothing but black coffee.

Control: 140ml of near-boiling water.

Sweetened-milk: 50g of low-fat cow's milk and 7,5g of white sugar is added into 140ml of near-boiling water.

The participant arrives in the morning with an empty stomach. He/she will give the first blood sample, then drink the test drink within 10 minutes. After 60 minutes, another blood sample will be taken. Then he/she will have to consume a standard breakfast made up of rice cereal, rice milk and glucose powder in 10 minutes. Investigators will make sure that the participant finishes the test drink and the standard breakfast.

With a total of 10 test drinks and each of them being tested in two sessions, each participant will take part in a total of 20 sessions. A washout period of three days is given between each session.

Intervention code [1]

Lifestyle

Comparator / control treatment

Water and the sugar-sweetened milk will also be provided as test drinks to the participants in 4 of the study sessions (2 each).

Control group

Active

Outcomes

Primary outcome [1]

Plasma glucose level in 3 hours during the session

Timepoint [1]

1 sample will be taken before consuming the test drink. 60 minutes later, another blood sample will be taken and the participant will consume the standard breakfast. After that another 6 samples will be taken at the following time after breakfast consumption: 15, 30, 45, 60, 90 and 120 minutes. The plasma glucose level will be measured using glucose oxidase commercial kits (Stanbio).

Whenever a study session is conducted using decaffeinated coffee, the glucose level will also be monitored using the FreeStyle Libre Flash Glucose Monitoring System (Berkshire, UK). A sensor will be inserted into participants' upper arm before the start of the experiment. A reading will be obtained by scanning the sensor, before collecting blood samples at each timepoint.

Primary outcome [2]

Plasma insulin levels for 3 hours during the sessions

Timepoint [2]

Secondary outcome [1]

Changes of the total and active GLP-1 levels in 3 hours during the session (composite).

Timepoint [1]

1 sample will be taken before consuming the test drink. 60 minutes later, another blood sample will be taken and the participant will consume the standard breakfast. After that another 6 samples will be taken at the following time after breakfast consumption: 15, 30, 45, 60, 90 and 120 minutes. Heparin-treated tubes are used to collect blood samples, which are then centrifuged to collect the plasma. Separate tubes with DPPIV-inhibitor added will be used to collect blood samples for active GLP-1 measurement.

Both total and active GLP-1 levels will be measured using ELISA.

Secondary outcome [2]

Plasma triglyceride levels for 3 hours during the session

Timepoint [2]

Secondary outcome [3]

Plasma total cholesterol level for 3 hours during the session

Timepoint [3]

Eligibility

Key inclusion criteria

1. Aged between 18-40 years old
2. Body mass index (BMI) WITHIN the range of 18.0-23.0
3. Consume at least 2 cups of coffee on a weekly basis in the past 3 months
4. Have never smoked before
5. Not a vegetarian
6. Able to tolerate cow’s milk
7. Able to tolerate caffeine or coffee
8. Not on regular medication, except oral contraceptives
9. Women who are not pregnant or does not plan to be pregnant during the study
10. Without high blood lipid or cholesterol
11. Without diagnosed type 1 or type 2 diabetes
12. Without current or history of cardiovascular diseases
13. Without current or history of liver diseases
14. Without current or history of gastrointestinal diseases
15. Without haemophobia

Minimum age

18 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Aged out of 18-40 years old
2. Body mass index (BMI) not within the range of 18.0-23.0
3. Consume less than 2 cups of coffee on a weekly basis in the past 3 months
4. Ex- or current smoker
5. Vegetarian
6. Unable to tolerate cow’s milk
7. Unable to tolerate caffeine or coffee
8. On regular medication, except oral contraceptives
9. Women who are pregnant or plan to be pregnant during the study
10. With high blood lipid or cholesterol
11. Diagnosed with type 1 or type 2 diabetes
12. With current or history of cardiovascular diseases
13. With current or history of liver diseases
14. With current or history of gastrointestinal diseases
15. Haemophobia

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/07/2016

Date of last participant enrolment

Anticipated

15/02/2017

Actual

17/05/2017

Date of last data collection

Anticipated

17/05/2017

Actual

20/09/2017

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Hong Kong

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Hong Kong

Address [1]

1 Pokfulam Road, Pokfulam

Country [1]

Hong Kong

Primary sponsor type

University

Name

The University of Hong Kong

Address

1 Pokfulam Road, Pokfulam

Country

Hong Kong

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee - University of Hong Kong Research Services

Ethics committee address [1]

9/F, Knowles Building, University of Hong Kong, 
1 Pokfulam Road, Pokfulam,
Hong Kong Special Administrative Region.

Ethics committee country [1]

Hong Kong

Date submitted for ethics approval [1]

01/03/2016

Approval date [1]

15/04/2016

Ethics approval number [1]

EA1604004

Summary

Brief summary

Coffee is a staple drink around the world and is mainly consumed for its arousing effect. Available in different types, including espresso, boiled and instant, coffee is becoming increasingly popular in Hong Kong. The protective effects of habitual coffee consumption towards several chronic diseases related to unhealthy lifestyles, such as type 2 diabetes mellitus (T2DM), cardiovascular diseases (CVD) and metabolic syndrome, have been demonstrated. However these findings contradict with the results of acute feeding studies, which found that coffee is capable of impairing the body's own ability to control blood sugar level. This project aims at investigating the acute effect of consuming different kinds of coffee on the different biomarkers in blood. This project will be able to demonstrate the difference in effects upon consuming different types of coffee, which can lead to further investigation of the biological mechanisms involved. Long term consumption studies may also be carried out so that a comparison between the short-term and long-term effects is possible.

Four types of coffee will be studied, including espresso, boiled, instant and decaffeinated coffee. After overnight fasting, each participant will consume a cup of test drink and consume a standard breakfast 60 minutes later. Blood samples will be taken to track the changes of the different metabolites during the session.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jimmy Chun Yu Louie

Address

5S-14, Kadoorie Biological Sciences Building,
The University of Hong Kong,
1 Pokfulam Road, Pokfulam,

Country

Hong Kong

Phone

+852 22990677

Fax

jimmyl@hku.hk

Contact person for public queries

Name

Tommy Hon Ting Wong

Address

5S-01, Kadoorie Biological Sciences Building,
The University of Hong Kong,
1 Pokfulam Road, Pokfulam

Country

Hong Kong

Phone

+852 22990832

Fax

tommywht@hku.hk

Contact person for scientific queries

Name

Tommy Hon Ting Wong

Address

5S-01, Kadoorie Biological Sciences Building,
The University of Hong Kong,
1 Pokfulam Road, Pokfulam

Country

Hong Kong

Phone

+852 22990832

Fax

tommywht@hku.hk

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

To protect the privacy of participants

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Consuming decaffeinated coffee with milk and sugar added before a high-glycaemic index meal improves postprandial glycaemic and insulinaemic responses in healthy adults.	2020	https://dx.doi.org/10.1017/S0007114520001750

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically