Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000655640
Ethics application status
Approved
Date submitted
7/05/2014
Date registered
23/06/2014
Date last updated
23/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The Fruit Study: Effects of different forms and types of fruits on glycaemic response, dietary compensation, and satiety in young adults and elderly
Scientific title
A randomised crossover intervention to compare the effects of different forms and types of fruits on glycaemic response, dietary compensation, and satiety in young adults and elderly
Secondary ID [1] 284490 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glycaemic response 291739 0
Condition category
Condition code
Diet and Nutrition 292107 292107 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 292492 292492 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised crossover study with four arms each containing 25 g of carbohydrate:
Arm 1: Guava puree
Arm 2: Guava bites
Arm 3: Papaya puree
Arm 4: Papaya bites

The results of these four treatments will be compared with the glucose beverage (reference). Guava and papaya have been chosen as they are popular tropical fruits in South East Asia and they differ in their sensory properties, i.e. colour, smell, taste, and texture.

All potential participants will be asked to provide informed consent during their screening session. They will then be asked to complete a screening questionnaire to determine their eligibility. Once their eligibility is confirmed, baseline measurements including anthropometric measurements, blood pressure, diet record, and physical activity level, will be collected from each participant. Following this, participants will be asked to attend a testing session on seven occasions: glucose beverage (reference) on three occasions, guava puree, guava bites, papaya puree, and papaya bites on a single occasion, where glycaemic index, dietary compensation, and satiety of each treatment will be measured. There will be at least a-day washout between treatments.
Intervention code [1] 289248 0
Prevention
Comparator / control treatment
This is a randomised crossover study where participants will act as their own control. In addition, the results obtained from the fruit products (i.e. guava puree, guava bites, papaya puree, and papaya bites) will be compared with those obtained from glucose beverage which contains 25 g of carbohydrate.
Control group
Active

Outcomes
Primary outcome [1] 292009 0
Glycaemic response will be measured by taking finger prick blood samples. Blood samples will be collected into a HemoCue Registered Trademark cuvette (Helsingborg, Sweden).
Timepoint [1] 292009 0
At the beginning of each testing session, two fasting blood samples will be collected. A further 1 to 2 samples may be taken in instances where the two baseline readings are far apart (i.e. the two blood glucose readings are more than 0.2 mmol/L apart). Participants will then consume a 25 g glucose beverage (reference) or a test food (guava or papaya puree or bites) containing 25 g of available carbohydrate within 15 minutes. Blood samples will be collected at 15, 30, 45, 60, 90, and 120 minutes after the two initial blood samples.
Secondary outcome [1] 308108 0
Sensory-specific satiety (SSS). Following the glycaemic response testing, participants will be provided with 150 kcal of guava and 150 kcal of papaya in the form that they consume during the glycaemic response testing in the morning. For instance, if the participants consume guava puree in the morning, both guava puree and papaya puree will be served at this time. Participants will be asked to consume the fruit product until they are satisfied within fifteen minutes. On the days where participants receive glucose for the glycaemic response testing, they will be asked to sit quietly for fifteen minutes. Once participants decide that they do not want to consume the fruit product any further at this occasion, they will be served with a buffet lunch. SSS will be assessed by measuring the amount of each fruit product that participants consume.
Timepoint [1] 308108 0
Fruits used to measure sensory-specific satiety will be served 120 minutes after consumption of the fruit product for the glycaemic response testing.
Secondary outcome [2] 308109 0
Dietary compensation for each treatment will be examined at two timepoints, i.e. energy intake during an ad libitum lunch and overall energy intake for the entire day.

Ad libitum lunch. At the end of each testing session, participants will be provided with buffet lunch consisting of two popular local dishes which can be purchased commercially. Participants are allowed to consume any amount of food as they wish (ad libitum intake).

Energy intake on testing session day. Participants will be asked to complete a one-day diet record on testing session day.
Timepoint [2] 308109 0
Ad libitum lunch will be served 135 minutes after consumption of the fruit product or the glucose beverage for the glycaemic response testing.

Energy intake on testing session day will be assessed throughout the day until participants go to bed.
Secondary outcome [3] 308110 0
Metabolic satiety. On the testing session days, participants will be asked to record their appetite ratings on a 100 mm visual analogue scale (VAS). The appetite-rating questionnaire will include questions on hunger, desire to eat, prospective consumption, fullness, and preoccupation with thoughts of food.
Timepoint [3] 308110 0
Immediately before they consume the fruit product or the glucose beverage for the glycaemic response testing, then at 15, 30, 45, 60, 90, and 120 minutes, after sensory-specific satiety test, after lunch, and hourly thereafter until they go to bed.

Eligibility
Key inclusion criteria
The inclusion criteria are healthy males and females between the ages of 21 and 35 years or between the ages of 61 and 75 years.
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria are
- People with major chronic disease such as heart disease, cancer or diabetes mellitus
- People with family history of diabetes
- Individuals with food intolerances or allergies to test products
- Individuals who are taking insulin or drugs known to affect glucose metabolism and body fat distribution
- People with a major medical or surgical event requiring hospitalization within the preceding 3 months
- Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
- Pregnant women

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be used. This will be achieved through allocation being performed by a researcher who will have no involvement in the enrollment process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be performed using a randomisation table generated from Research Randomizer (Version 4.0) http://www.randomizer.org/
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of twenty participants, consisting of ten young adults and ten elderly, will be recruited to take part in the study. Participants would be replaced accordingly should there be any drop out or missing data. This sample size is based on the international standard guidelines outlined in ISO 26642:2010, which is used for the determination of the GI and recommendation for food classification. Baseline characteristics of the participants will be presented as arithmetic means and standard deviations. Categorical data will be presented as frequencies and percentages. Linear mixed models with a random participant effect to account for the underlying correlation between the repeated measures will be used to examine the effects of different forms and types of fruits on ‘glucose’, ‘dietary compensation’ and 'satiety'. Interactions between fruit type and form will also be performed. Stata 11.1 (StataCorp, College Station, TX, USA) will be used for all statistical analyses. Two sided P<0.05 will be considered statistically significant in all cases.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2014
Actual
Date of last participant enrolment
Anticipated
31/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 6035 0
Singapore
State/province [1] 6035 0

Funding & Sponsors
Funding source category [1] 289180 0
Government body
Name [1] 289180 0
Singapore Institute for Clinical Sciences, A*STAR
Country [1] 289180 0
Singapore
Primary sponsor type
Government body
Name
Singapore Institute for Clinical Sciences, A*STAR
Address
Brenner Centre for Molecular Medicine
30 Medical Drive
Singapore 117609
Country
Singapore
Secondary sponsor category [1] 287849 0
None
Name [1] 287849 0
Address [1] 287849 0
Country [1] 287849 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290960 0
Singapore National Healthcare Group Domain Specific Review Board
Ethics committee address [1] 290960 0
Ethics committee country [1] 290960 0
Singapore
Date submitted for ethics approval [1] 290960 0
Approval date [1] 290960 0
05/06/2014
Ethics approval number [1] 290960 0
2014/00057

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47910 0
Dr Agnes Siew Ling Tey
Address 47910 0
14 Medical Drive #07-02
Yong Loo Lin School of Medicine
Singapore 117599
Country 47910 0
Singapore
Phone 47910 0
+65 6407 0741
Fax 47910 0
+65 6774 7134
Email 47910 0
[email protected]
Contact person for public queries
Name 47911 0
Agnes Siew Ling Tey
Address 47911 0
14 Medical Drive #07-02
Yong Loo Lin School of Medicine
Singapore 117599
Country 47911 0
Singapore
Phone 47911 0
+65 6407 0741
Fax 47911 0
+65 6774 7134
Email 47911 0
[email protected]
Contact person for scientific queries
Name 47912 0
Agnes Siew Ling Tey
Address 47912 0
14 Medical Drive #07-02
Yong Loo Lin School of Medicine
Singapore 117599
Country 47912 0
Singapore
Phone 47912 0
+65 6407 0741
Fax 47912 0
+65 6774 7134
Email 47912 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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