The Effects on Glycemic and Insulinemic Responses by Fruit Consumption (TGIF)

August 19, 2021 updated by: JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117599
        • Clinical Nutrition Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test 1
Other: Test 1
25g of available carbohydrates from White bread with 25g of available carbohydrates from Banana consumed simultaneously at time 0 min
Experimental: Test 2
Other: Test 2
25g of available carbohydrates from Banana consumed at time -15 min and 25g of available carbohydrates from white bread consumed at time 0 min
Experimental: Test 3
Other: Test 3
25g of available carbohydrates from White bread consumed at time 0 min and 25g of available carbohydrates from Banana consumed at time 15 min
Experimental: Test 4
Other: Test 4
25g of available carbohydrates from White bread with 25g of available carbohydrates from Papaya consumed simultaneously at time 0 min
Experimental: Test 5
Other: Test 5
25g of available carbohydrates from White bread with 25g of available carbohydrates from Apple consumed simultaneously at time 0 min

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
180min

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Differences in postprandial glycaemic response among banana, papaya and apple
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)
180min
Differences in insulinaemic response among banana, papaya and apple
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)
180min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinical Nutrition Research Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019/00691

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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