Drinking soft drinks fast or slow, which one is better?
| ISRCTN | ISRCTN14798840 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14798840 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Koc University Research Center for Translational Medicine (KUTTAM) |
| Funder | Koc University Research Center for Translational Medicine (KUTTAM), funded by The Presidency of Turkey, Presidency of Strategy and Budget |
- Submission date
- 21/05/2021
- Registration date
- 01/06/2021
- Last edited
- 08/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Drinking sweetened beverages is associated with an increased risk of heart disease and type 2 diabetes. The aim of this study is to determine if the speed of drinking the sweetened beverage alters the effects of fructose (fruit sugar).
Who can participate?
Healthy adult volunteers who are free of any chronic illness and do not routinely use any medication
What does the study involve?
Participants are randomly allocated to one of two groups. After overnight fasting, participants in group 1 drink 500 ml of apple juice over an hour by drinking 125 ml every 15 minutes, while subjects in group 2 drink 500 ml of apple juice over 5 minutes. Blood samples are collected at 0, 15, 30, 60, and 120 minutes after ingestion to be tested for levels of sugar and other factors.
What are the possible benefits and risks of participating?
Participation is on a voluntary basis and does not provide individual benefits. Risks include the risks of having blood drawn, which are mainly temporary pain due to needle stick and bruising.
Where is the study run from?
Koc University Hospital (Turkey)
When is the study starting and how long is it expected to run for?
June 2020 to December 2020
Who is funding the study?
Koc University Research Center for Translational Medicine (KUTTAM) (Turkey)
Who is the main contact?
Prof. Dr. Mehmet Kanbay
mkanbay@ku.edu.tr
Contact information
Scientific
Koc University Hospital Topkapi
Davutpasa Cd. No:4
Istanbul
34010
Türkiye
 ORCID ID |
0000-0002-1297-0675 |
|---|---|
| Phone | +90 (0)5423536986 |
| mkanbay@ku.edu.tr |
Public
Koc University Hospital Topkapi
Davutpasa Cd. No:4
Istanbul
34010
Türkiye
| ORCID ID |
0000-0002-6318-4199 |
|---|---|
| Phone | +90 (0)5369334311 |
| lertuglu14@ku.edu.tr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | ISRCTN14798840_PIS.doc |
| Scientific title | The effects of speed of ingestion of a sugary beverage on the acute metabolic response to fructose |
| Study acronym | SPEFRU |
| Study objectives | It is hypothesized that the metabolic effects of fructose in sugary beverages might be modulated by the speed of ingestion in addition to the overall amount. |
| Ethics approval(s) | Approved 10/06/2020, Koc University Committee on Human Research (Rumelifeneri Mahallesi, Rumelifeneri Yolu, 34450, Sariyer, Istanbul, Turkey; +90 (0)212 338 11 76; chr@ku.edu.tr), ref: 2020.275.IRB1.098 |
| Health condition(s) or problem(s) studied | Determination of the metabolic response to fructose after fast versus slow ingestion of 100% fruit juice |
| Intervention | Thirty healthy, nonobese participants without any systemic disease and receiving no medications and alcohol are included in this study. Each subject is given a total of 500 ml of 100% pure, commercially available apple juice to consume during the intervention. The participants are randomly allocated to either group 1 or group 2. The study used 100% apple juice as the fructose source since it has a higher fructose-to-glucose ratio and has no antioxidant effect. Each participant drinks the same apple juice. The participants in group 1 are instructed to drink 125 ml every 15 min under direct supervision four times until a total of 500 ml is consumed. The participants in group 2 are instructed to drink 500 ml of apple juice within 5 min under direct supervision. No other eating or drinking is allowed during the 2 h study period for both groups. The subjects do not perform any physical activity during the study period. Blood samples are collected for laboratory analysis at baseline and 15, 30, 60, and 120 min after apple juice consumption initiation |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Serum glucose measured using a Roche Cobas 6000 analyzer (Roche, Mannheim, Germany) at baseline, and 15, 30, 60, and 120 min after drinking apple juice |
| Key secondary outcome measure(s) |
HOMA-IR measured using the following formula: HOMA-IR = (plasma glucose × plasma insulin/405), where glucose is in mass units (mg/dL), measured using a Roche Cobas 6000 analyzer (Roche, Mannheim, Germany) and calculated for baseline, and 15, 30, 60, and 120 min after drinking apple juice |
| Completion date | 01/12/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Healthy, nonobese participants 2. No systemic diseases 3. Not taking medications or alcohol |
| Key exclusion criteria | 1. Obesity 2. Any systemic disease 3. Receiving any medications routinely 4. Significant alcohol use |
| Date of first enrolment | 01/09/2020 |
| Date of final enrolment | 01/12/2020 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Davutpaşa Cd. No:4
Istanbul
34010
Türkiye
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Dr Mehmet Kanbay (mkanbay@ku.edu.tr). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 02/06/2021 | 08/06/2021 | Yes | No | |
| Participant information sheet | 08/07/2021 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN14798840_PIS.doc
- Uploaded 08/07/2021
Editorial Notes
08/07/2021: The participant information sheet has been uploaded.
08/06/2021: Publication reference added.
26/05/2021: Trial's existence confirmed by Koc University Committee on Human Research.
