The Fruit Study: Effects of different forms and types of fruits on glycaemic response, dietary compensation, and satiety in young adults and elderly

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000655640
• Date of registration: 23/06/2014
• Prospective Registration: Yes
• Primary sponsor: Singapore Institute for Clinical Sciences, A*STAR
• 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
• Date of first enrolment: 01/07/2014
• Target sample size: 20
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12614000655640.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Singapore

Contacts

• Name: Dr Agnes Siew Ling Tey

• Name: Dr Agnes Siew Ling Tey

Key inclusion & exclusion criteria

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.
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

Age minimum: 21 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Diet and Nutrition - Other diet and nutrition disorders

Glycaemic response;
Glycaemic response

Metabolic and Endocrine - Diabetes

Intervention(s)

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.

Primary Outcome(s)

Glycaemic response will be measured by taking finger prick blood samples. Blood samples will be collected into a HemoCue Registered Trademark cuvette (Helsingborg, Sweden). [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(s)

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. [Fruits used to measure sensory-specific satiety will be served 120 minutes after consumption of the fruit product for the glycaemic response testing. ]

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. [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. ]

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. [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 ID(s)

Nil

Source(s) of Monetary Support

Singapore Institute for Clinical Sciences, A*STAR

Ethics review

Status: Approved
Approval date:
Contact:

Singapore National Healthcare Group Domain Specific Review Board