Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/05/2017
Date assigned
08/06/2017
Last edited
08/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dimitrios Papandreou

ORCID ID

http://orcid.org/0000-0002-4923-484X

Contact details

Zayed University
Khalifa B City
Abudhabi
144534
United Arab Emirates

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TDM_25_2015

Study information

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

Acronym

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

Ethical Committee of Zayed University and Doctors' Medical Center, 25/11/2016, ref: ZU_081-F and TDMC_25_2015

Study design

Interventional non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Blood glucose

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

Phase

Drug names

Primary outcome measures

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 trial start date

10/05/2017

Overall trial end date

10/06/2017

Reason abandoned

Eligibility

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 type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

20

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

Trial participating centre

The Doctors Medical Center
Villa T6 Al Batten Street Khalydia
AbuDhabi
144539
United Arab Emirates

Sponsor information

Organisation

The Doctors Medical Center

Sponsor details

106 Batten Str Khalydia
Abu Dhabi
63086
United Arab Emirates

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Zayed University

Alternative name(s)

ZU

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Arab Emirates

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

10/12/2017

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes