NCT02969057

Brief Summary

The objective of the present study is to compare the effects of liquid or solid state of food on glycaemia, lipaemia and insulinaemia. 25 participants aged between 21 and 45 years will be recruited from the general public in Singapore. Fingerpricks and cannulation may cause minor discomfort and there may be some slight bruising around the site. Fingerpricks and cannulation will be done by an experienced research nurse or a trained research officer to minimize participant discomfort. If bruising does occur, it should disappear within one day and it should not affect participants' regular daily activity. Participants will be limited to a maximum of one test per week. In addition, blood collection will be carried out in a sterile designated area and thus the risk of infection will be very low. On rare occasions, participants may feel unwell during or after the testing session. We have several metabolic suites with beds for these individuals to rest on. The research nurse and research officers will monitor the individuals' condition and they will be provided with a ride home if required. All the study foods will be prepared in a hygienic manner in a purpose-built research kitchen maintained to the highest hygiene standards. The research staff has undergone basic training in food hygiene procedures. Hence, the risk of infective acute gastroenteritis will be minimal. Participants will be provided with some snacks at the end of each testing session. They will also be reimbursed to compensate for their time and costs associated with travel and parking at the completion of the study. In addition, participants will be provided with their blood glucose, blood pressure, and body composition results, with a brief interpretation of these at the conclusion of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

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

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

November 17, 2016

Last Update Submit

July 17, 2018

Conditions

Glucose Response

Keywords

Lipidemic Response

Outcome Measures

Primary Outcomes (3)

  • Change in postprandial blood glucose over 180 minutes period

    Blood obtained through fingerprick, analysed using Hemocue analyser.

    180 minutes

  • Change in postprandial serum triglyceride over 360 minutes period

    Venous blood obtain through cannula, analysed using Cobas analyser. Venous plasma triglyceride will be assessed at 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180, 210, 240, 270, 300, 330 and 360 minutes

    360 minutes

  • Change in postprandial serum glucose over 360 minutes period

    Venous blood obtain through cannula, analysed using Cobas analyser. Venous plasma triglyceride will be assessed at 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180, 210, 240, 270, 300, 330 and 360 minutes

    360 minutes

Secondary Outcomes (2)

  • Change in postprandial plasma insulin over 360 minutes period

    360 minutes

  • Change in postprandial appetite over 360 minutes period

    360 minutes

Study Arms (5)

Breakfast only

NO INTERVENTION

Control breakfast providing 50g carbohydrate

Breakfast with rice bran oil gel

ACTIVE COMPARATOR

Control breakfast, plus 25g rice bran oil gel (solid)

Other: Breakfast with rice bran oil gel

Breakfast with rice bran oil

ACTIVE COMPARATOR

Control breakfast, plus 25g rice bran oil (liquid)

Other: Breakfast with rice bran oil

Breakfast with palm oil gel

ACTIVE COMPARATOR

Control breakfast, plus 25g palm oil gel (solid)

Other: Breakfast with palm oil gel

Breakfast with palm oil

ACTIVE COMPARATOR

Control breakfast, plus 25g palm oil (liquid)

Other: Breakfast with palm oil

Interventions

Breakfast with rice bran oil gelOTHER

25 grams of rice bran oil gel

Breakfast with rice bran oil gel
Breakfast with rice bran oilOTHER

25 grams of rice bran oil

Breakfast with rice bran oil
Breakfast with palm oil gelOTHER

25 grams of palm oil gel

Breakfast with palm oil gel
Breakfast with palm oilOTHER

25 grams of palm oil

Breakfast with palm oil

Eligibility Criteria

Age21 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Chinese male
  • Age between 21 and 45 years
  • BMI 18-25 kg/m2
  • Body weight \>/=45 kg
  • Normal Blood Pressure (=140/90 mmHg)
  • Normal Fasting Blood Glucose (\<6.0 mM)

You may not qualify if:

  • People who take part in sports at competitive/endurance levels•
  • People with major chronic disease such as heart disease, cancer or diabetes mellitus
  • People who are glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
  • People who have intolerances or allergies to test products
  • Individuals who are taking 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 three months
  • Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
  • People who are on any therapeutic diet/ drug therapy
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JeyaKumar Henry

Singapore, Singapore

Location

Related Publications (1)

  • Tan SY, Peh E, Siow PC, Marangoni AG, Henry CJ. Effects of the physical-form and the degree-of-saturation of oil on postprandial plasma triglycerides, glycemia and appetite of healthy Chinese adults. Food Funct. 2017 Dec 13;8(12):4433-4440. doi: 10.1039/c7fo01194f.

    PMID: 29090299DERIVED

MeSH Terms

Interventions

BreakfastRice Bran OilPalm Oil

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

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
Principle Investigator

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 21, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

SG(1)