NCT04115592

Brief Summary

The aim of this study is to investigate if the application of lipid in various form (i.e. liquid and solid) affects glycaemia, lipaemia and insulinaemia. In addition, this study aims to test the lipidemic effects of the use of vegetable oil as a substitute in the application for making chocolate confectionery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2019

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

February 20, 2019

Completed
8 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
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2020

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

October 3, 2019

Last Update Submit

August 19, 2021

Conditions

Diabetes Mellitus, Type 2Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (2)

  • Postprandial triglycerides

    Venous blood plasma measured using the COBAS

    From 0 to 360 minutes

  • Postprandial glucose

    Venous blood plasma measured using the COBAS

    From 0 to 360 minutes

Secondary Outcomes (1)

  • Postprandial insulin

    From 0 to 360 minutes

Study Arms (4)

Liquid oil type 1

EXPERIMENTAL

Cocoa butter (CB)

Other: Cocoa butter

Solid oil type 1

EXPERIMENTAL

Cocoa butter oleogel (CBOG)

Other: Cocoa butter oleogel

Liquid oil type 2

EXPERIMENTAL

Sal seed oil (SL)

Other: Sal seed oil

Solid oil type 2

EXPERIMENTAL

Sal seed oleogel (SLOG)

Other: Sal seed oleogel

Interventions

Cocoa butterOTHER

Consumption of cocoa butter made with chocolate confectionery

Liquid oil type 1
Cocoa butter oleogelOTHER

Consumption of cocoa butter oleogel made with chocolate confectionery

Solid oil type 1
Sal seed oilOTHER

Consumption of sal seed oil made with chocolate confectionery

Liquid oil type 2
Sal seed oleogelOTHER

Consumption of sal seed oleogel made with chocolate confectionery

Solid oil type 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, and tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, 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 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
  • 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 2

Interventions

cocoa butter

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 4, 2019

Study Start

February 20, 2019

Primary Completion

January 16, 2020

Study Completion

March 9, 2020

Last Updated

August 20, 2021

Record last verified: 2021-08

Locations

SG(1)