The Oil, Fats and Oleogel Study (OFO)

• ClinicalTrials.gov Identifier: NCT02702726
• Recruitment Status: Completed
• First Posted: March 9, 2016
• Last Update Posted: August 23, 2017
• Sponsor: Clinical Nutrition Research Centre, Singapore
• Information provided by (Responsible Party): JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

Tracking Information

• First Submitted Date: February 29, 2016
• First Posted Date: March 9, 2016
• Last Update Posted Date: August 23, 2017
• Actual Study Start Date: January 12, 2016
• Actual Primary Completion Date: May 23, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 3, 2016)

• 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]
• 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]
• 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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 3, 2016)

• 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]
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Oil, Fats and Oleogel Study
• 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
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Glycaemic Response and Energy Balance

Intervention

• Other: Congee and juice with coconut gel
  25g coconut oleogel
• Other: Congee and juice with coconut oil
  25g coconut oil
• Other: Congee and juice with sunflower gel
  25g sunflower oleogel
• Other: Congee and juice with sunflower oil
  25g sunflower oil

Study Arms

• 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)
  Intervention: Other: Congee and juice with coconut gel
• Active Comparator: Congee and juice with coconut oil
  Control breakfast, plus 25g coconut oil (liquid)
  Intervention: Other: Congee and juice with coconut oil
• Active Comparator: Congee and juice with sunflower gel
  Control breakfast, plus 25g sunflower oleogel (solid)
  Intervention: Other: Congee and juice with sunflower gel
• Active Comparator: Congee and juice with sunflower oil
  Control breakfast, plus 25g sunflower oil (liquid)
  Intervention: Other: Congee and juice with sunflower oil

• Publications *: Tan SY, Peh E, Lau E, Marangoni AG, Henry CJ. Physical Form of Dietary Fat Alters Postprandial Substrate Utilization and Glycemic Response in Healthy Chinese Men. J Nutr. 2017 Jun;147(6):1138-1144. doi: 10.3945/jn.116.246728. Epub 2017 May 10.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 28, 2016): 16
• Original Estimated Enrollment (submitted: March 3, 2016): 24
• Actual Study Completion Date: May 23, 2017
• Actual Primary Completion Date: May 23, 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 21 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT02702726
• Other Study ID Numbers: 2015/01093
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Not applicable for this study

• Responsible Party: JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore
• Study Sponsor: Clinical Nutrition Research Centre, Singapore
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Clinical Nutrition Research Centre, Singapore
• Verification Date: August 2017