The Oil, Fats and Oleogel Study

Glycaemic Response and Energy Balance Clinical Trial

— OFO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702726
• Other study ID #: 2015/01093
• Status: Completed
• Phase: N/A
• First received: February 29, 2016
• Last updated: August 21, 2017
• Start date: January 12, 2016
• Est. completion date: May 23, 2017

Study information

• Verified date: August 2017
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 23, 2017
• Est. primary completion date: May 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Glycaemic Response and Energy Balance

Intervention

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

Locations

Country	Name	City	State
Singapore	Clinical Nutrition Research Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	180-min postprandial energy expenditure (kJ/min over 180 minutes and total kJ/180-min session) measured by an indirect ventilated-hood calorimeter	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 minutes
Primary	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	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]	180 minutes
Primary	Post-test-meal capillary blood glucose (mmol/L) at 0, 15, 30, 45, 60, 90, 120, 150, 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)	180 minutes
Secondary	Post-test-meal subjective appetite measurements at 0, 15, 30, 45, 60, 90, 120, 150, 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]	180 minutes
Secondary	Free-living food intake after completion of test session	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.	180 minutes