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Completed

NCT Number: NCT02702726

The Oil, Fats and Oleogel Study

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.

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Key information

Age range

21 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Research Centre

Singapore, 117599

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Congee and juice with coconut gel

Other

25g coconut oleogel

Congee and juice with coconut oil

Other

25g coconut oil

Congee and juice with sunflower gel

Other

25g sunflower oleogel

Congee and juice with sunflower oil

Other

25g sunflower oil

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Singapore Institute of Food and Biotechnology Innovation

Other Gov

Registry information

Official study 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

Acronym: OFO

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2016
Registry last updated
Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.