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The Oil, Fats and Oleogel Study (OFO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02702726
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

Study Description
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Brief Summary:
The aim of this study is to compare the effects of dietary fats, ingested in two physical forms, on acute energy balance, appetitive, and glycemic responses of healthy normal (BMI 18-24.9 kgm-2) or overweight (BMI>25kgm-2) adults.

Condition or disease Intervention/treatment Phase
Glycaemic Response and Energy Balance Other: Congee and juice with coconut gel Other: Congee and juice with coconut oil Other: Congee and juice with sunflower gel Other: Congee and juice with sunflower oil Not Applicable

Detailed Description:
This will be a randomised, crossover study. Randomisation will be performed with an online randomisation software (www.randomizer.org). Participants will be screened (1 screening visit) and attend five test visits conducted in a whole room calorimeter (WRC). During each test visit, participants will arrive at the laboratory after an overnight fast, enter the WRC and rest for 15 minutes in a supine position,have their resting energy expenditure (REE) measured for 30 minutes and consume congee and juice alone(control), or with one of the 4 dietary fats: sunflower oil (SO) or gel (SG) and coconut oil (CO) or gel (CG) (total 5 test visits). Post-meal energy expenditure, fat oxidation, glycemia and appetite (visual analog scales) will be measured continuously for 3 hours in WRC, followed by a meal challenge where participants will eat until sated. Participants will return and repeat the protocol until all fat types and forms are completed.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Oil, Fats and Oleogel (OFO) Study: Effects of Dietary Fats, Ingested in Two Physical Forms, on Acute Human Energy Balance, Appetitive and Glycemic Responses
Actual Study Start Date : January 12, 2016
Actual Primary Completion Date : May 23, 2017
Actual Study Completion Date : May 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fats

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Congee and juice only
Control breakfast providing 50g carbohydrate
Active Comparator: Congee and juice with coconut gel
Control breakfast, plus 25g coconut oleogel (solid)
 Other: Congee and juice with coconut gel
25g coconut oleogel
Active Comparator: Congee and juice with coconut oil
Control breakfast, plus 25g coconut oil (liquid)
 Other: Congee and juice with coconut oil
25g coconut oil
Active Comparator: Congee and juice with sunflower gel
Control breakfast, plus 25g sunflower oleogel (solid)
 Other: Congee and juice with sunflower gel
25g sunflower oleogel
Active Comparator: Congee and juice with sunflower oil
Control breakfast, plus 25g sunflower oil (liquid)
 Other: Congee and juice with sunflower oil
25g sunflower oil


Outcome Measures
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Primary Outcome Measures :
  1. 180-min postprandial energy expenditure (kJ/min over 180 minutes and total kJ/180-min session) measured by an indirect ventilated-hood calorimeter [ Time Frame: 180 minutes ]
    Gaseous exchanges obtained from the indirect calorimeter (volume of oxygen consumed and volume of carbon dioxide produced) will be used to calculate energy expenditure using the Weir equation: EE = 3.9 VO2 + 1.1 VCO2 [Weir, J. B. (1949). "New methods for calculating metabolic rate with special reference to protein metabolism." Journal of Physiology 109(1): 1-9]

  2. 180-min postprandial carbohydrate and fat oxidation (kJ/min over 180 minutes and total kJ and total grams during each session) measured by an indirect ventilated-hood calorimeter [ Time Frame: 180 minutes ]
    Gaseous exchanges obtained from the indirect calorimeter (volume of oxygen consumed and volume of carbon dioxide produced) will be used to calculate energy expenditure using the Frayn equations: carbohydrate oxidation = 4.55 VCO2 - 3.21 VO2; fat oxidation = 1.67 VO2 - 1.67 VCO2 [Frayn, K. N. (1983). "Calculation of substrate oxidation rates in vivo from gaseous exchange." Journal of Applied Physiology 55(2): 628-634]

  3. Post-test-meal capillary blood glucose (mmol/L) at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes [ Time Frame: 180 minutes ]
    Capillary blood glucose will be assessed at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes using a Hemocue system (HemoCue Glucose 201 RT Systems, Helsingborg, Sweden)


Secondary Outcome Measures :
  1. Post-test-meal subjective appetite measurements at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes [ Time Frame: 180 minutes ]
    Appetite ratings will be collected at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes after test meal consumption using a previously validated visual analog scales [Flint, A., A. Raben, J. E. Blundell and A. Astrup (2000). "Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies." International Journal of Obesity 24(1): 38-48]

  2. Free-living food intake after completion of test session [ Time Frame: 180 minutes ]
    Participants will be asked to keep a food record that document the types and amount of food and beverage they consume after they leave the research centre, until they go to bed on the same day. Data will be analysed using nutrient analysis software.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Exclusion Criteria:

  • People with major chronic disease such as heart disease, cancer, hypertension or diabetes mellitus
  • People with known food allergies, due to potential traces of allergens found in the commercially available food product used in our study (Knorr's instant congee)
  • People who are claustrophobic
  • Individuals who are taking insulin or drugs known to affect glucose metabolism, appetite, and body fat distribution
  • Have weight change of >5kg in the past 3 months
  • People with a major medical or surgical event requiring hospitalization within the preceding three months
  • People who are on a weight loss regime
  • Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702726


Locations
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Singapore
Clinical Nutrition Research Centre
Singapore, Singapore, 117599
Sponsors and Collaborators
Clinical Nutrition Research Centre, Singapore
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: JeyaKumar Henry, Principal Investigator, Clinical Nutrition Research Centre, Singapore
ClinicalTrials.gov Identifier: NCT02702726    
Other Study ID Numbers: 2015/01093
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not applicable for this study