HealthyTGIFNCT05008978
The Effects on Glycemic and Insulinemic Responses by Fruit Consumption
A study testing Test 1, Test 2 and Test 3 in people with Healthy, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
The health benefits of fruits and their importance in a healthy diet have long been known. Several intervention studies have included the promotion of fruit as part of the healthy diet and epidemiologic evidences have demonstrated that a diet rich in fruits is associated with the reduction in the risk of many chronic… Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test 1, Test 2 and Test 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Oct 2019to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Chinese Ethnicity
- Age between 21-50 years
- Weight of at least 45 kg
- Body mass index between 18.5 - 25 kg/m2 (inclusive)
- Fasting blood glucose < 5.6 mmol/L
- Normal blood pressure ≤140/90 mmHg
Who cannot join
- People who smoke
- People with any metabolic diseases or cardiovascular diseases (such as heart disease, hypertension, diabetes mellitus, etc.)
- Having any other diseases involving the small intestine or the colon (e.g., irritable bowel syndrome, inflammatory bowel disease, gastric reflux) or having any liver or kidney disorders or any family history of kidney stones
- People with known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Have any history of severe vasovagal syncope (blackouts or near faints) following blood draws
- People taking any prescribed medication or dietary supplements which may interfere with the study measurements
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- People with medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
- Individuals who have any major organ dysfunction (e.g. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug
- Individuals who have any known food allergies to the food components of the study protocol
- People who intentionally restrict food intake
- Individuals who partake in sports at the competitive and/or endurance levels
- People having active Tuberculosis (TB) or currently receiving treatment for TB
- People who have any known chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
- People who are a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- Have known history of anaemia or thalassemia minor
- Enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC
- Participants who are found to be repeatedly difficult to cannulate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects on Glycemic and Insulinemic Responses by Fruit Consumption (TGIF Study)
The health benefits of fruits and their importance in a healthy diet have long been known. Several intervention studies have included the promotion of fruit as part of the healthy diet and epidemiologic evidences have demonstrated that a diet rich in fruits is associated with the reduction in the risk of many chronic diseases, including type 2 diabetes. Such beneficial health effects of fruits could be attributed to the presence of dietary fiber, micronutrients (vitamins and minerals), antioxidants and phytochemicals found in them. However, up to our knowledge, no study has investigate the time-course effects on the co-ingestion of fruits with other food product on postprandial glycaemic response (GR) and insulinaemic response (IR). The time-course effect will be examined in this study in order to determine its optimal effect on GR and IR. The investigators also aimed to compare the effects of varying micronutrients content in fruits on GR and IR.
Read the detailed description
Type 2 diabetes is one of the most common non-communicable diseases found in 415 million adults worldwide in 2015 and the number is expected to increase to 642 million in 2040. This has serious consequences for healthcare expenditure as it has been estimated that the global health expenditure on diabetes is at least USD$673 billion in 2015 and is forecasted to increase to USD$802 billion in 2040. This creates a major public health burden and effective treatments and prevention strategies are necessary. The Asian phenotype has been shown to be more susceptible to diabetes compared to the Western phenotype where more than half (56%) of the population with type 2 diabetes lived in the South-East Asia Region or the Western Pacific Region in 2015.Pharmacological methods through the use of drugs and insulin remains as the conventional strategy in the management of type 2 diabetes. However, in recent years, dietary interventions have been used as a mean to prevent or delay the onset of type 2 diabetes. Food has now become the new medicine and a healthy diet is widely believed to play an important role in the prevention of the development of type 2 diabetes.The health benefits of fruits and their importance in a healthy diet have long been established. Several intervention studies have included the promotion of fruit as part of the healthy diet with epidemiological evidences demonstrating that a diet rich in fruits is associated with a reduction in the risk of many chronic diseases, including type 2 diabetes. Such beneficial health effects of fruits may be attributed to the presence of dietary fibre, micronutrients (vitamins and minerals), antioxidants and phytochemicals found in them. However, to our knowledge, no study has investigated the time-course effects of co-ingesting fruits with a carbohydrate-based food product on postprandial glycaemic response (GR) and insulinaemic response (IR). GR and IR is the effect a food product has on blood glucose and insulin levels respectively, after consumption. Better control of GR and IR were found to be associated with a lower risk of development of type 2 diabetes and other cardiovascular diseases. Studies have shown that soluble dietary fibre, which are found in fruits, decrease the rise in blood glucose and insulin level. Addition of fibre as a food ingredient was also found to modulate glucose response by improving insulin sensitivity. Antioxidants and phytochemicals in fruits have also been hypothesized to improve insulin sensitivity and hence protect against diabetes. In the second part of the study, the investigators aim to compare the effects of varying micronutrients content in fruits on GR and IR. Fruits have highly variable contents of fibre, antioxidants, other nutrients, and phytochemicals that may jointly influence the risk of metabolic diseases. It has been reported that the consumption of higher anthocyanins content had an inverse relationship with the risk of developing type 2 diabetes. Varying content of resveratrol, chlorogenic acid and naringin have also been reported to have an association with the risk of type 2 diabetes in animal studies. Due to the heterogeneous composition found in fruits, it may be plausible that different fruits have varying effects on GR and IR. Therefore, the investigators hypothesized that varying micronutrients content in fruit plays an essential role in the association with diabetes risk due to a difference in GR and IR. In this proposed study, the investigators will thus determine whether different micronutrients content present in different fruits have an effect on postprandial on GR and IR.
- Conditions
- Healthy
- Being tested
- Test 1, Test 2, Test 3, Test 4, Test 5
- Keywords
- time effects on fruit consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test 1Other
25g of available carbohydrates from White bread with 25g of available carbohydrates from Banana consumed simultaneously at time 0 min
Test 2Other
25g of available carbohydrates from Banana consumed at time -15 min and 25g of available carbohydrates from white bread consumed at time 0 min
Test 3Other
25g of available carbohydrates from White bread consumed at time 0 min and 25g of available carbohydrates from Banana consumed at time 15 min
Test 4Other
25g of available carbohydrates from White bread with 25g of available carbohydrates from Papaya consumed simultaneously at time 0 min
Test 5Other
25g of available carbohydrates from White bread with 25g of available carbohydrates from Apple consumed simultaneously at time 0 min
| Study group | Role | What they receive |
|---|---|---|
| Test 1 | Experimental | Not described Receives: Other: Test 1 |
| Test 2 | Experimental | Not described Receives: Other: Test 2 |
| Test 3 | Experimental | Not described Receives: Other: Test 3 |
| Test 4 | Experimental | Not described Receives: Other: Test 4 |
| Test 5 | Experimental | Not described Receives: Other: Test 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial blood glucose
Baseline venous blood was collected by cannulation into Vacutainers® (Belton Dickinson Diagnostics) containing disodium EDTA. Analyse using Beckman Coulter analyser. (time frame 180min)
Measured: 180min
Secondary outcomes (2)
Differences in postprandial glycaemic response among banana, papaya and apple
Baseline venous blood was collected by cannulation into Vacutainers® (Belton Dickinson Diagnostics) containing disodium EDTA. Analyse using Beckman Coulter analyser. (time frame 180min)
Measured: 180min
Differences in insulinaemic response among banana, papaya and apple
Baseline venous blood was collected by cannulation into Vacutainers® (Belton Dickinson Diagnostics) containing disodium EDTA. Analyse using Beckman Coulter analyser. (time frame 180min)
Measured: 180min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start25 Oct 2019
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008978
- Sponsor's protocol ID
- 2019/00691
- Other IDs
- 2019
- Acronym
- TGIF
- Status last verified
- Aug 2021
- First submitted
- 12 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects on Glycemic and Insulinemic Responses by Fruit Consumption (TGIF Study)
- ClinicalTrials.gov ID
- NCT05008978
- Acronym / sponsor ID
- TGIF / 2019/00691
- Conditions
- Healthy
- Keywords
- time effects on fruit consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The health benefits of fruits and their importance in a healthy diet have long been known. Several intervention studies have included the promotion of fruit as part of the healthy diet and epidemiologic evidences have demonstrated that a diet rich in fruits is associated with the reduction in the risk of many chronic diseases, including type 2 diabetes. Such beneficial health effects of fruits could be attributed to the presence of dietary fiber, micronutrients (vitamins and minerals), antioxidants and phytochemicals found in them. However, up to our knowledge, no study has investigate the time-course effects on the co-ingestion of fruits with other food product on postprandial glycaemic response (GR) and insulinaemic response (IR). The time-course effect will be examined in this study in order to determine its optimal effect on GR and IR. The investigators also aimed to compare the effects of varying micronutrients content in fruits on GR and IR.
Detailed description
Type 2 diabetes is one of the most common non-communicable diseases found in 415 million adults worldwide in 2015 and the number is expected to increase to 642 million in 2040. This has serious consequences for healthcare expenditure as it has been estimated that the global health expenditure on diabetes is at least USD$673 billion in 2015 and is forecasted to increase to USD$802 billion in 2040. This creates a major public health burden and effective treatments and prevention strategies are necessary. The Asian phenotype has been shown to be more susceptible to diabetes compared to the Western phenotype where more than half (56%) of the population with type 2 diabetes lived in the South-East Asia Region or the Western Pacific Region in 2015.Pharmacological methods through the use of drugs and insulin remains as the conventional strategy in the management of type 2 diabetes. However, in recent years, dietary interventions have been used as a mean to prevent or delay the onset of type 2 diabetes. Food has now become the new medicine and a healthy diet is widely believed to play an important role in the prevention of the development of type 2 diabetes.The health benefits of fruits and their importance in a healthy diet have long been established. Several intervention studies have included the promotion of fruit as part of the healthy diet with epidemiological evidences demonstrating that a diet rich in fruits is associated with a reduction in the risk of many chronic diseases, including type 2 diabetes. Such beneficial health effects of fruits may be attributed to the presence of dietary fibre, micronutrients (vitamins and minerals), antioxidants and phytochemicals found in them. However, to our knowledge, no study has investigated the time-course effects of co-ingesting fruits with a carbohydrate-based food product on postprandial glycaemic response (GR) and insulinaemic response (IR). GR and IR is the effect a food product has on blood glucose and insulin levels respectively, after consumption. Better control of GR and IR were found to be associated with a lower risk of development of type 2 diabetes and other cardiovascular diseases. Studies have shown that soluble dietary fibre, which are found in fruits, decrease the rise in blood glucose and insulin level. Addition of fibre as a food ingredient was also found to modulate glucose response by improving insulin sensitivity. Antioxidants and phytochemicals in fruits have also been hypothesized to improve insulin sensitivity and hence protect against diabetes. In the second part of the study, the investigators aim to compare the effects of varying micronutrients content in fruits on GR and IR. Fruits have highly variable contents of fibre, antioxidants, other nutrients, and phytochemicals that may jointly influence the risk of metabolic diseases. It has been reported that the consumption of higher anthocyanins content had an inverse relationship with the risk of developing type 2 diabetes. Varying content of resveratrol, chlorogenic acid and naringin have also been reported to have an association with the risk of type 2 diabetes in animal studies. Due to the heterogeneous composition found in fruits, it may be plausible that different fruits have varying effects on GR and IR. Therefore, the investigators hypothesized that varying micronutrients content in fruit plays an essential role in the association with diabetes risk due to a difference in GR and IR. In this proposed study, the investigators will thus determine whether different micronutrients content present in different fruits have an effect on postprandial on GR and IR.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Test 1 | Experimental | Other: Test 1 |
| Test 2 | Experimental | Other: Test 2 |
| Test 3 | Experimental | Other: Test 3 |
| Test 4 | Experimental | Other: Test 4 |
| Test 5 | Experimental | Other: Test 5 |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male
- Chinese Ethnicity
- Age between 21-50 years
- Weight of at least 45 kg
- Body mass index between 18.5 - 25 kg/m2 (inclusive)
Key exclusion criteria (17 listed)
- People who smoke
- People with any metabolic diseases or cardiovascular diseases (such as heart disease, hypertension, diabetes mellitus, etc.)
- Having any other diseases involving the small intestine or the colon (e.g., irritable bowel syndrome, inflammatory bowel disease, gastric reflux) or having any liver or kidney disorders or any family history of kidney stones
- People with known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Have any history of severe vasovagal syncope (blackouts or near faints) following blood draws
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test 125g of available carbohydrates from White bread with 25g of available carbohydrates from Banana consumed simultaneously at time 0 min | Other | Test 1 |
| Test 225g of available carbohydrates from Banana consumed at time -15 min and 25g of available carbohydrates from white bread consumed at time 0 min | Other | Test 2 |
| Test 325g of available carbohydrates from White bread consumed at time 0 min and 25g of available carbohydrates from Banana consumed at time 15 min | Other | Test 3 |
| Test 425g of available carbohydrates from White bread with 25g of available carbohydrates from Papaya consumed simultaneously at time 0 min | Other | Test 4 |
| Test 525g of available carbohydrates from White bread with 25g of available carbohydrates from Apple consumed simultaneously at time 0 min | Other | Test 5 |
Primary outcome
Change in postprandial blood glucose
Time frame: 180min
Baseline venous blood was collected by cannulation into Vacutainers® (Belton Dickinson Diagnostics) containing disodium EDTA. Analyse using Beckman Coulter analyser. (time frame 180min)
2 secondary outcomes
Differences in postprandial glycaemic response among banana, papaya and apple
Time frame: 180min
Differences in insulinaemic response among banana, papaya and apple
Time frame: 180min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test 1, Test 2 and Test 3 in people with Healthy, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postprandial blood glucose (time frame: 180min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.