Effects of fruit and juices on glucose and insulin
| ISRCTN | ISRCTN10834747 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10834747 |
| Secondary identifying numbers | TDM_25_2015 |
- Submission date
- 24/05/2017
- Registration date
- 08/06/2017
- Last edited
- 23/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims:
There is increasing concern that consumption of free sugars, particularly in the form of sugar-sweetened drinks, may lead to a reduced intake of nutritious foods and increased total calorie intake, leading to an unhealthy diet, weight gain and increased risk of disease. The WHO suggests that the amount of sugar in the diet should drop from 10% to 5% as energy, mainly derived from natural foods such as fruit juices and honey. Fruit juices have a high glycaemic index, meaning that they cause a spike in blood sugar levels. However a recent study showed that fruit juice consumption does not have a significant effect on the fasting sugar and insulin (the hormone which helps the body to process sugar) levels. In addition, the influence of ghrelin (the hormone which makes people feel hungry) on blood sugar control may also be related. There is a lack of studies investigating the effects of different fruit juices on blood sugar and insulin responses at the after meals. Therefore, the aim of the present study is to investigate the effects of fruits, particularly orange and various orange juices on blood sugar and insulin levels immediately after consumption in healthy young adults.
Who can participate?
Healthy adults aged 18-22 of normal weight and obese adults of the same age.
What does the study involve?
All participants attend a total of three study visits on three consecutive days. On the first visit participants consume a raw orange, on the second visit they consume 100% fresh orange juice, and on the third visit they consume nectar sweetened orange juice. Before consuming the drink and then 30, 60, 90 and 120 minutes after, participants have samples of blood collected to test their blood sugar and insulin levels
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.
Where is the study run from?
The Doctors Medical Center (United Arab Emirates)
When is study starting and how long is it expected to run for?
July 2016 to July 2020
Who is funding the study?
Zayed University (United Arab Emirates)
Who is the main contact?
Professor Dimitrios Papandreou
Contact information
Scientific
Zayed University
Khalifa B City
Abudhabi
144534
United Arab Emirates
 ORCID ID |
0000-0002-4923-484X |
|---|
Study information
| Study design | Interventional non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effects of raw orange, 100% fresh orange juice and nectar sweetened orange juice on plasma blood glucose, insulin and ghrelin levels among normal and obese adults |
| Study hypothesis | The nectar sweetened orange juice and the 100% fresh juice will not significantly increase blood glucose and insulin levels post-prandially. |
| Ethics approval(s) | Ethical Committee of Zayed University and Doctors' Medical Center, 25/11/2016, ref: ZU_081-F and TDMC_25_2015 |
| Condition | Blood glucose levels in healthy people after consumption of fruit or fruit juice |
| Intervention | 10 normal and 10 obese participants attend three study visits on consecutive days. Visit 1: Participants consume the raw orange Visit 2: Participants consume 100% fresh orange juice Visit 3: Participants consume nectar sweetened orange juice Blood glucose, insulin, and ghrelin will be evaluated at 0, 30, 60, 90 and 120 minutes post-prandially on each study visit. |
| Intervention type | Other |
| Primary outcome measure | 1.Plasma Glucose is measured by hexokinase enzymatic method (Cobas, Roche USA) at baseline and 30, 60, 90 and 120 minutes postprandial 2. Plasma Insulin is measured by ECLIA method (Cobas 6000, Roche, USA) at baseline and 30, 60, 90 and 120 minutes postprandial |
| Secondary outcome measures | Ghrelin levels are measured by immunochemilunometric assay (IDS, SMBH, Germany) at baseline and 30, 60, 90 and 120 minutes postprandial. |
| Overall study start date | 10/05/2017 |
| Overall study end date | 10/06/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 22 Years |
| Sex | Female |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Participant inclusion criteria | Healthy participants: 1. Aged 18-22 years 2. Female 3. Healthy 4. BMI < 25 Obese participants: 1. Aged 18-22 years 2. Female 3. Healthy 4. BMI > 27 |
| Participant exclusion criteria | 1. Males 2. Aged under 18 and over 22 years 3. Taking medications, supplements 4. Being on a specific diet |
| Recruitment start date | 15/05/2017 |
| Recruitment end date | 30/05/2017 |
Locations
Countries of recruitment
- United Arab Emirates
Study participating centre
Khalydia
AbuDhabi
144539
United Arab Emirates
Sponsor information
Hospital/treatment centre
106 Batten Str Khalydia
Abu Dhabi
63086
United Arab Emirates
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- ZU
- Location
- United Arab Emirates
Results and Publications
| Intention to publish date | 30/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/09/2019 | 23/10/2019 | Yes | No |
Editorial Notes
23/10/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
29/08/2018: The intention to publish date was changed from 10/12/2017 to 30/09/2018.
