Glycaemic Response and Energy BalanceOFONCT02702726
The Oil, Fats and Oleogel Study
A study testing Congee and juice with coconut gel, Congee and juice with coconut oil and Congee and juice with sunflower gel in people with Glycaemic Response and Energy Balance, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glycaemic Response and Energy Balance
- What is being tested?
- Congee and juice with coconut gel, Congee and juice with coconut oil and Congee and juice with sunflower gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSingapore
- Study dates
- 12 Jan 2016to 23 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Glycaemic Response and Energy Balance
- Being tested
- Congee and juice with coconut gel, Congee and juice with coconut oil, Congee and juice with sunflower gel, Congee and juice with sunflower oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Congee and juice with coconut gelOther
25g coconut oleogel
Congee and juice with coconut oilOther
25g coconut oil
Congee and juice with sunflower gelOther
25g sunflower oleogel
Congee and juice with sunflower oilOther
25g sunflower oil
| Study group | Role | What they receive |
|---|---|---|
| Congee and juice only | No intervention | Control breakfast providing 50g carbohydrate |
| Congee and juice with coconut gel | Active comparator | Control breakfast, plus 25g coconut oleogel (solid) Receives: Other: Congee and juice with coconut gel |
| Congee and juice with coconut oil | Active comparator | Control breakfast, plus 25g coconut oil (liquid) Receives: Other: Congee and juice with coconut oil |
| Congee and juice with sunflower gel | Active comparator | Control breakfast, plus 25g sunflower oleogel (solid) Receives: Other: Congee and juice with sunflower gel |
| Congee and juice with sunflower oil | Active comparator | Control breakfast, plus 25g sunflower oil (liquid) Receives: Other: Congee and juice with sunflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 180 minutes
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]
Measured: 180 minutes
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)
Measured: 180 minutes
Secondary outcomes (2)
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]
Measured: 180 minutes
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.
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start12 Jan 2016
- Primary completion23 May 2017
- Study completion23 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glycaemic Response and Energy BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702726
- Sponsor's protocol ID
- 2015/01093
- Other IDs
- 2015
- Acronym
- OFO
- Status last verified
- Aug 2017
- First submitted
- 29 Feb 2016
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not applicable for this study
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.
PubMed 28490674
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02702726
- Acronym / sponsor ID
- OFO / 2015/01093
- Conditions
- Glycaemic Response and Energy Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Congee and juice only | No intervention | –Control breakfast providing 50g carbohydrate |
| Congee and juice with coconut gel | Active comparator | Other: Congee and juice with coconut gelControl breakfast, plus 25g coconut oleogel (solid) |
| Congee and juice with coconut oil | Active comparator | Other: Congee and juice with coconut oilControl breakfast, plus 25g coconut oil (liquid) |
| Congee and juice with sunflower gel | Active comparator | Other: Congee and juice with sunflower gelControl breakfast, plus 25g sunflower oleogel (solid) |
| Congee and juice with sunflower oil | Active comparator | Other: Congee and juice with sunflower oilControl breakfast, plus 25g sunflower oil (liquid) |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Congee and juice with coconut gel25g coconut oleogel | Other | Congee and juice with coconut gel |
| Congee and juice with coconut oil25g coconut oil | Other | Congee and juice with coconut oil |
| Congee and juice with sunflower gel25g sunflower oleogel | Other | Congee and juice with sunflower gel |
| Congee and juice with sunflower oil25g sunflower oil | Other | Congee and juice with sunflower oil |
Primary outcome
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)
2 secondary outcomes
Post-test-meal subjective appetite measurements at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
Time frame: 180 minutes
Free-living food intake after completion of test session
Time frame: 180 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Derived from this study: PubMed 28490674Tan 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.
- Individual participant dataSharing planned: No. Not applicable for this study
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Congee and juice with coconut gel, Congee and juice with coconut oil and Congee and juice with sunflower gel in people with Glycaemic Response and Energy Balance, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02702726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.