Clinical trial NCT02702726: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycaemic Response and Energy Balance
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
First posted: 2016-03-09
Enrollment: 16
Sex: MALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 180-min postprandial energy expenditure (kJ/min over 180 minutes and total kJ/180-min session) measured by an indirect ventilated-hood calorimeter
timeFrame: 180 minutes
measure: 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
timeFrame: 180 minutes
measure: Post-test-meal capillary blood glucose (mmol/L) at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
timeFrame: 180 minutes
Secondary outcomes:
measure: Post-test-meal subjective appetite measurements at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
timeFrame: 180 minutes
measure: Free-living food intake after completion of test session
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
References:
citation: 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.