NCT02875275

Brief Summary

This study examines the metabolic effects of 3 possible test meals (Oleogel) and/or 3 possible test meals (Grass Jelly). The participants will have the option to voluntarily choose which study part(s) to participate. This study will be evaluated on 40 healthy Chinese male subjects from the general public over a period of one year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable diabetes

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

January 12, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
Last Updated

August 2, 2017

Status Verified

August 1, 2017

Enrollment Period

6 months

First QC Date

August 1, 2016

Last Update Submit

August 1, 2017

Conditions

DiabetesCardiovascular Disease

Outcome Measures

Primary Outcomes (2)

  • Change in postprandial blood glucose over 180 minutes period

    Blood obtained through fingerprick, analysed using Hemocue analyser. Capillary blood glucose will be assessed at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes.

    180 minutes

  • Change in postprandial plasma triglyceride over 360 minutes period

    Venous blood obtain through cannula, analysed using Cobas analyser. Venous plasma triglyceride will be assessed at 0, 10, 20, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360 minutes.

    360 minutes

Secondary Outcomes (1)

  • Change in postprandial plasma insulin over 360 minutes period

    360 minutes

Study Arms (6)

Glucose Solution only

NO INTERVENTION

Control drink containing 50 g carbohydrate

Glucose with grass jelly solution

ACTIVE COMPARATOR

Control drink plus 3.12 g grass jelly powder

Other: Glucose with grass jelly solution

Glucose with grass jelly (solid)

ACTIVE COMPARATOR

Control drink plus 3.12 g grass jelly powder in solid form

Other: Glucose with grass jelly (solid)

Porridge and juice only

NO INTERVENTION

Control breakfast containing 50 g carbohydrate.

Porridge and juice with coconut oil

ACTIVE COMPARATOR

Control breakfast, plus 25g coconut oil

Other: Porridge and juice with coconut oil

Porridge and juice with coconut oil gel

ACTIVE COMPARATOR

Control breakfast, plus 25g coconut oil gel

Other: Porridge and juice with coconut oil gel

Interventions

Glucose with grass jelly solutionOTHER

50 g glucose and 3.12 g grass jelly dissolve in water (top up to 200g)

Glucose with grass jelly solution
Glucose with grass jelly (solid)OTHER

50 g glucose and 3.12 g grass jelly and 3.12g starch dissolve in hot water (top up to 200g)

Glucose with grass jelly (solid)
Porridge and juice with coconut oilOTHER

Add instant porridge with hot water with oil. Consume with commercially available orange juice

Porridge and juice with coconut oil
Porridge and juice with coconut oil gelOTHER

Add instant porridge with hot water with oleogel. Consume with commercially available orange juice

Porridge and juice with coconut oil gel

Eligibility Criteria

Age21 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • Body Mass Index 18-25 kg/m2
  • Body weight more than or equals to 45kg
  • Normal blood pressure (≤140/90) and normal fasting blood glucose (\<6.0 mM)

You may not qualify if:

  • Have major chronic disease such as heart disease, cancer or diabetes mellitus, intolerances or allergies to test products
  • User of insulin or drugs known to affect glucose metabolism and body fat distribution
  • People with a major medical or surgical event requiring hospitalization within the preceding 3 months
  • Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
  • Current smokers
  • People who are on any therapeutic diet/drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Reseach Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Diabetes MellitusCardiovascular Diseases

Interventions

GlucosePolymethyl MethacrylateCoconut Oil

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesMethylmethacrylatesPolymethacrylic AcidsAcrylatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAcrylic ResinsResins, SyntheticPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureDietary FatsFatsLipidsPlant OilsOils

Study Officials

  • JeyaKumar Christiani, Phd

    Clinical Nutrition Research Centre

    PRINCIPAL INVESTIGATOR

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 1, 2016

First Posted

August 23, 2016

Study Start

January 12, 2016

Primary Completion

June 27, 2016

Study Completion

June 27, 2016

Last Updated

August 2, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)