The Effects on Glycemic and Insulinemic Responses by Fruit Consumption

NCT05008978 | Completed

• 1 other identifier: 2019/00691
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy

Keywords

time effects on fruit consumption

Outcome Measures

Primary Outcomes (1)

• 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)

  180min

Secondary Outcomes (2)

• Differences in postprandial glycaemic response among banana, papaya and apple

  180min

• Differences in insulinaemic response among banana, papaya and apple

  180min

Study Arms (5)

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

Interventions

Test 1 OTHER

25g of available carbohydrates from White bread with 25g of available carbohydrates from Banana consumed simultaneously at time 0 min

Test 1

Test 2 OTHER

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 2

Test 3 OTHER

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 3

Test 4 OTHER

25g of available carbohydrates from White bread with 25g of available carbohydrates from Papaya consumed simultaneously at time 0 min

Test 4

Test 5 OTHER

25g of available carbohydrates from White bread with 25g of available carbohydrates from Apple consumed simultaneously at time 0 min

Test 5

Eligibility Criteria

• Age: 21 Years - 50 Years
• Gender Eligibility Details: All healthy male subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 17, 2021
• Study Start: October 25, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)