NCT04115657

Brief Summary

The first objective is to investigate the effect of boba pearls made from different starches on glycaemia, insulinaemia and appetite control. The second objective is to investigate the effects of various sugar blends of sucrose with sugar substitutes in milk tea on glycaemia, insulinaemia and appetite control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2019

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

October 3, 2019

Last Update Submit

August 29, 2023

Conditions

Diabete Type 2Obese

Outcome Measures

Primary Outcomes (2)

  • Postprandial glucose

    Venous blood plasma measured using the COBAS

    From 0 to 180 minutes

  • Postprandial insulin

    Venous blood plasma measured using the COBAS

    From 0 to 180 minutes

Secondary Outcomes (1)

  • Appetite control

    From 0 to 180 minutes

Study Arms (6)

Starch 1

EXPERIMENTAL

Tapioca starch

Other: Starch 1

Starch 2

EXPERIMENTAL

High amylose

Other: Starch 2

Starch 3

EXPERIMENTAL

Kithul flour

Other: Starch 3

Starch 4

EXPERIMENTAL

Sago flour

Other: Starch 4

Sugar 1

EXPERIMENTAL

Pure palatinose

Other: Sugar 1

Sugar 2

EXPERIMENTAL

Blend of sucrose and palatinose

Other: Sugar 2

Interventions

Starch 1OTHER

Consumption of milk tea with sucrose and boba pearls made from tapioca starch

Starch 1
Starch 2OTHER

Consumption of milk tea with sucrose and boba pearls made from high amylose

Starch 2
Starch 3OTHER

Consumption of milk tea with sucrose and boba pearls made from kithul flour

Starch 3
Starch 4OTHER

Consumption of milk tea with sucrose and boba pearls made from sago flour

Starch 4
Sugar 1OTHER

Consumption of milk tea with pure palatinose and boba pearls made from tapioca starch

Sugar 1
Sugar 2OTHER

Consumption of milk tea with blend of sucrose and palatinose and boba pearls made from tapioca starch

Sugar 2

Eligibility Criteria

Age21 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAll healthy male volunteers
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males
  • Healthy Asian Chinese
  • Aged between 21 - 40 years
  • ≥45kg body weight
  • Body mass index between 18.5 to 25.0 kg/m2
  • Normal blood pressure ≤140/90 mmHg
  • Fasting blood glucose \<5.6 mmol/L

You may not qualify if:

  • Smoking
  • Allergic/intolerant to any of the test foods to be administered, or any of the following common food and ingredients: eggs, fish, milk, peanuts, tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, sulphites etc.
  • Anyone with intentional food restrictions
  • People with known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
  • Having metabolic or cardiovascular diseases (such as diabetes, hypertension, heart condition, etc.)
  • Having medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
  • Taking any prescribed medication or dietary supplements which may interfere with the study measurements
  • Individuals who have any major organ dysfunction (eg. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug
  • Excessive alcohol consumption: consuming ≥ 6 alcoholic drinks per week
  • Have 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)
  • Have active Tuberculosis (TB) or currently receiving treatment for TB
  • Individuals who partake in sports at the competitive and/or endurance levels
  • A team member of the study or is an immediate family member (Immediate family defined as a spouse, parent, child, or sibling, whether biological or legally adopted)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Interventions

starch synthase IV, Arabidopsis

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 4, 2019

Study Start

May 2, 2019

Primary Completion

November 5, 2019

Study Completion

December 30, 2022

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)