CarotenoidsNCT04323826
Effect of the Type and Emulsification of Dietary Fat on the Carotenoids Absorption
A study testing olive oil-water mixture, olive oil-water emulsion and coconut oil-water mixture in people with Carotenoids, run by National University of Singapore at 2 sites in Singapore.
Trial summary
This study is designed to assess the effects of 1) the emulsification 2) the type of dietary fat on carotenoid (CAT) absorption employing an in-vitro digestion system (Proof of Concept) and well-designed randomized controlled trial. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotenoids
- What is being tested?
- olive oil-water mixture, olive oil-water emulsion and coconut oil-water mixture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Apr 2021to 1 Sep 2021
- 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to give an informed consent
- Age 19 to 45 years
- Willing to follow the study procedures
Who cannot join
- Significant weight change > 3 kg in the past 3 months;
- Exercising vigorously over the past 3 months (*Defined as having > 6 metabolic equivalents of exercise daily; approximately 20 mins of moderate intensity exercise (e.g. slow jogging);
- Intestinal disorders including lipid malabsorption;
- Diabetes or prediabetes (fasting blood glucose > 100 mg/dL);
- Smoking;
- Drinking more than 2 alcoholic drinks per day;
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- Taking lipid-lowering medications or dietary supplements affecting plasma lipid-lipoprotein concentration.
- Menopausal women, those using hormone based contraceptives, those having abnormal menstrual cycles, and those who are pregnant, lactating or planning to become pregnant.
- Following any restricted diet (e.g. vegetarian)
- Taking dietary supplements which may impact the outcome of interests (e.g. carotenoids supp.)
- Insufficient venous access to allow the blood collection
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Department of Food Science and Technology; National University of Singapore
Singapore, 117546
Investigational Medical Unit (IMU)
Singapore, 117599
About this study
Official title: Effect of the Type and Emulsification of Dietary Fat on the Bioavailability of Fat-soluble Nutrients in Human
This study is designed to assess the effects of 1) the emulsification 2) the type of dietary fat on carotenoid (CAT) absorption employing an in-vitro digestion system (Proof of Concept) and well-designed randomized controlled trial.
Read the detailed description
In all, twenty-five healthy men and women (aged =19 and =45 y, approximately half men and half women, with the expectation that = 20 subjects will complete the study (= 20 % dropout rate)) will be recruited and each subject will participate in 4 trials (randomized and crossover). Anthropometric measurements, including height, weight, waist circumference, blood pressure as well as skin scan carotenoids status will be measured on the screening day as subject baseline information. Prior to each trial, subjects are required a compliance test (CT) visit. On that day, fasting blood will be drawn to analysis the CAT concentration and compare the analyzed CAT concentration to those of testing day baseline to assess the compliance of the washout diet period. Skin CAT scan status will also be conducted. After the CT day, subjects will undergo a 7-day washout period and follow low-CAT diet to reduce circulating, endogenous levels of CAT and minimize the contribution of CAT in the plasma. During the first 5 days, subjects will consume a low-CAT diet (CAT<750µg), and during the 6-7days, subjects will consume an even low-CAT diet (CAT<500µg). The low-CAT diet menu sheet will be provided and dietary instruction to achieve the low CAT diet will be given. Compliance with the low CAT diet will be promoted by daily menu check-off lists and in-person contact on visit day.Subject will be randomly assigned to consume a carefully portioned mix-vegetable salad (including tomatoes, shredded carrots, spinach, lettuce, and Chinese wolfberry) with 4 different oil-water combinations on the 4 meal testing (MT) day. The 4 different oil-water combinations are as follows:1) Olive oil-water mixture (non-emulsified, rich in unsaturated fat);2) Olive oil-water emulsification (rich in unsaturated fat);3) Coconut oil-water mixture (non-emulsified, rich in saturated fat);4) Coconut oil-water emulsification (emulsified, rich in unsaturated fat).On every MT day, fasting blood will be collected for analyzing the CAT levels every 60 minutes for 10 hours and CAT concentration, triglycerides will be analyzed from the collected blood samples. Appetite VAS questionnaire will be conducted every half hour in the first two hours after consuming test meal and hourly conducted till the 5th hour when lunch ( low-CAT (< 2000 µg), low-fat (<2 g)) provided. After consuming the lunch, Appetite VAS questionnaire will be conducted every half hour in the first two hours and hourly till the 10th hour. Thus, the timepoint for appetite VAS measurement will be at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 9, 10 hour.There are no incidental findings in the current research as we will only collect subject's biological sample (blood) for testing the carotenoids level and blood triglycerides level which are the aim of this study. The rest measurements, including blood pressure, weight, height and waist circumference, they are the baseline information we collect for this study.
- Conditions
- Carotenoids
- Being tested
- olive oil-water mixture, olive oil-water emulsion, coconut oil-water mixture, coconut oil-water emulsion
- Keywords
- Carotenoids absorption, blood triglycerides, postprandial lipid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olive oil-water mixtureOther
50% olive oil in water, processed with high shear mixer at 8000 rpm power without adding emulsifier, well shaked before consumption.
olive oil-water emulsionOther
50% olive oil in water (4% whey protein isolate), stirred for 5 mins using a high shear mixer at 8000 rpm power and was further processed with high pressure homogenizer at 100 MPa.
coconut oil-water mixtureOther
50% coconut oil in water, processed with high shear mixer at 8000 rpm power without adding emulsifier, well shaked before consumption.
coconut oil-water emulsionOther
50% coconut oil in water (4% whey protein isolate), stirred for 5 mins using a high shear mixer at 8000 rpm power and was further processed with high pressure homogenizer at 100 MPa.
| Study group | Role | What they receive |
|---|---|---|
| salads with olive oil-water mixture | Experimental | Vegetable salads (100g tomatoes, 62g carrots, 70g spinach, 25g lettuce and 5g wolfberry) with 56g olive oil-water mixture will be provided to consume. Receives: Other: olive oil-water mixture |
| salads with olive oil-water emulsion | Experimental | Vegetable salads (100g tomatoes, 62g carrots, 70g spinach, 25g lettuce and 5g wolfberry) with 56g olive oil-water emulsion (4% whey protein isolate as emulsifier) will be provided to consume. Receives: Other: olive oil-water emulsion |
| salads with coconut oil-water emulsion | Experimental | Vegetable salads (100g tomatoes, 62g carrots, 70g spinach, 25g lettuce and 5g wolfberry) with 56g coconut oil-water emulsion (4% whey protein isolate as emulsifier) will be provided to consume. Receives: Other: coconut oil-water emulsion |
| salads with coconut oil-water mixture | Experimental | Vegetable salads (100g tomatoes, 62g carrots, 70g spinach, 25g lettuce and 5g wolfberry) with 56g coconut oil-water mixture will be provided to consume. Receives: Other: coconut oil-water mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood carotenoids concentrations
Five main carotenoids compounds, lutein, zeaxanthin, α-carotene, β-carotene and lycopene concentrations will be determined in blood via HPLC.
Measured: Up to 6 months
Blood triglycerides concentrations
Plasma triglyceride concentration will be determined by using a Cobas c311 chemistry analyzer (Roche Diagnostics, Asia Pacific).
Measured: Up to 6 months
Secondary outcomes (5)
Skin carotenoid status
Measured using resonance Raman spectroscopy.
Measured: Up to 4 months
Height
Height (cm)
Measured: Baseline data, up to 4 weeks
Weight
Weight (kg)
Measured: Baseline data, up to 4 weeks
Waist circumference
waist circumference (cm)
Measured: Baseline data, up to 4 weeks
Diet
Dietary analysis via 3-day food record
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Apr 2021
- Primary completion31 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CarotenoidsStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Institute of Food and Biotechnology Innovation
- Responsible party
- Principal investigator, Jung Eun Kim, National University of Singapore
- Investigators
- KIM Jung EUN, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323826
- Sponsor's protocol ID
- S10
- Status last verified
- Sep 2021
- First submitted
- 24 Mar 2020
- Last updated
- 10 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JE, Gordon SL, Ferruzzi MG, Campbell WW. Effects of egg consumption on carotenoid absorption from co-consumed, raw vegetables. Am J Clin Nutr. 2015 Jul;102(1):75-83. doi: 10.3945/ajcn.115.111062. Epub 2015 May 27.
PubMed 26016861Mak IEK, Yao Y, Xu Y, Kim JE. Plasma carotenoids and skin carotenoid status response following short-term changes in carotenoid intakes: a randomised clinical trial. Eur J Nutr. 2025 Oct 21;64(8):302. doi: 10.1007/s00394-025-03824-5.
PubMed 41117881Yao Y, Yang Z, Yin B, Goh HM, Toh DWK, Kim JE. Effects of dietary fat type and emulsification on carotenoid absorption: a randomized crossover trial. Am J Clin Nutr. 2023 May;117(5):1017-1025. doi: 10.1016/j.ajcnut.2023.03.011. Epub 2023 Mar 13.
PubMed 36921903
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Type and Emulsification of Dietary Fat on the Bioavailability of Fat-soluble Nutrients in Human
- ClinicalTrials.gov ID
- NCT04323826
- Acronym / sponsor ID
- S10
- Conditions
- Carotenoids
- Keywords
- Carotenoids absorption, blood triglycerides, postprandial lipid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Singapore Institute of Food and Biotechnology Innovation
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 27 Mar 2020 (actual)
- 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.
This study is designed to assess the effects of 1) the emulsification 2) the type of dietary fat on carotenoid (CAT) absorption employing an in-vitro digestion system (Proof of Concept) and well-designed randomized controlled trial.
Detailed description
In all, twenty-five healthy men and women (aged =19 and =45 y, approximately half men and half women, with the expectation that = 20 subjects will complete the study (= 20 % dropout rate)) will be recruited and each subject will participate in 4 trials (randomized and crossover). Anthropometric measurements, including height, weight, waist circumference, blood pressure as well as skin scan carotenoids status will be measured on the screening day as subject baseline information. Prior to each trial, subjects are required a compliance test (CT) visit. On that day, fasting blood will be drawn to analysis the CAT concentration and compare the analyzed CAT concentration to those of testing day baseline to assess the compliance of the washout diet period. Skin CAT scan status will also be conducted. After the CT day, subjects will undergo a 7-day washout period and follow low-CAT diet to reduce circulating, endogenous levels of CAT and minimize the contribution of CAT in the plasma. During the first 5 days, subjects will consume a low-CAT diet (CAT<750µg), and during the 6-7days, subjects will consume an even low-CAT diet (CAT<500µg). The low-CAT diet menu sheet will be provided and dietary instruction to achieve the low CAT diet will be given. Compliance with the low CAT diet will be promoted by daily menu check-off lists and in-person contact on visit day.Subject will be randomly assigned to consume a carefully portioned mix-vegetable salad (including tomatoes, shredded carrots, spinach, lettuce, and Chinese wolfberry) with 4 different oil-water combinations on the 4 meal testing (MT) day. The 4 different oil-water combinations are as follows:1) Olive oil-water mixture (non-emulsified, rich in unsaturated fat);2) Olive oil-water emulsification (rich in unsaturated fat);3) Coconut oil-water mixture (non-emulsified, rich in saturated fat);4) Coconut oil-water emulsification (emulsified, rich in unsaturated fat).On every MT day, fasting blood will be collected for analyzing the CAT levels every 60 minutes for 10 hours and CAT concentration, triglycerides will be analyzed from the collected blood samples. Appetite VAS questionnaire will be conducted every half hour in the first two hours after consuming test meal and hourly conducted till the 5th hour when lunch ( low-CAT (< 2000 µg), low-fat (<2 g)) provided. After consuming the lunch, Appetite VAS questionnaire will be conducted every half hour in the first two hours and hourly till the 10th hour. Thus, the timepoint for appetite VAS measurement will be at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 8, 9, 10 hour.There are no incidental findings in the current research as we will only collect subject's biological sample (blood) for testing the carotenoids level and blood triglycerides level which are the aim of this study. The rest measurements, including blood pressure, weight, height and waist circumference, they are the baseline information we collect for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| salads with olive oil-water mixture | Experimental | Other: olive oil-water mixtureVegetable salads (100g tomatoes, 62g carrots, 70g spinach, 25g lettuce and 5g wolfberry) with 56g olive oil-water mixture will be provided to consume. |
| salads with olive oil-water emulsion | Experimental | Other: olive oil-water emulsionVegetable salads (100g tomatoes, 62g carrots, 70g spinach, 25g lettuce and 5g wolfberry) with 56g olive oil-water emulsion (4% whey protein isolate as emulsifier) will be provided to consume. |
| salads with coconut oil-water emulsion | Experimental | Other: coconut oil-water emulsionVegetable salads (100g tomatoes, 62g carrots, 70g spinach, 25g lettuce and 5g wolfberry) with 56g coconut oil-water emulsion (4% whey protein isolate as emulsifier) will be provided to consume. |
| salads with coconut oil-water mixture | Experimental | Other: coconut oil-water mixtureVegetable salads (100g tomatoes, 62g carrots, 70g spinach, 25g lettuce and 5g wolfberry) with 56g coconut oil-water mixture will be provided to consume. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ability to give an informed consent
- Age 19 to 45 years
- Willing to follow the study procedures
Key exclusion criteria (11 listed)
- Significant weight change > 3 kg in the past 3 months;
- Exercising vigorously over the past 3 months (*Defined as having > 6 metabolic equivalents of exercise daily; approximately 20 mins of moderate intensity exercise (e.g. slow jogging);
- Intestinal disorders including lipid malabsorption;
- Diabetes or prediabetes (fasting blood glucose > 100 mg/dL);
- Smoking;
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 |
|---|---|---|
| olive oil-water mixture50% olive oil in water, processed with high shear mixer at 8000 rpm power without adding emulsifier, well shaked before consumption. | Other | salads with olive oil-water mixture |
| olive oil-water emulsion50% olive oil in water (4% whey protein isolate), stirred for 5 mins using a high shear mixer at 8000 rpm power and was further processed with high pressure homogenizer at 100 MPa. | Other | salads with olive oil-water emulsion |
| coconut oil-water mixture50% coconut oil in water, processed with high shear mixer at 8000 rpm power without adding emulsifier, well shaked before consumption. | Other | salads with coconut oil-water mixture |
| coconut oil-water emulsion50% coconut oil in water (4% whey protein isolate), stirred for 5 mins using a high shear mixer at 8000 rpm power and was further processed with high pressure homogenizer at 100 MPa. | Other | salads with coconut oil-water emulsion |
Primary outcome
Blood carotenoids concentrations
Time frame: Up to 6 months
Five main carotenoids compounds, lutein, zeaxanthin, α-carotene, β-carotene and lycopene concentrations will be determined in blood via HPLC.
Blood triglycerides concentrations
Time frame: Up to 6 months
Plasma triglyceride concentration will be determined by using a Cobas c311 chemistry analyzer (Roche Diagnostics, Asia Pacific).
5 secondary outcomes
Skin carotenoid status
Time frame: Up to 4 months
Height
Time frame: Baseline data, up to 4 weeks
Weight
Time frame: Baseline data, up to 4 weeks
Waist circumference
Time frame: Baseline data, up to 4 weeks
Diet
Time frame: Up to 6 months
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 10 Sep 2021.
- Background: PubMed 26016861Kim JE, Gordon SL, Ferruzzi MG, Campbell WW. Effects of egg consumption on carotenoid absorption from co-consumed, raw vegetables. Am J Clin Nutr. 2015 Jul;102(1):75-83. doi: 10.3945/ajcn.115.111062. Epub 2015 May 27.
- Derived from this study: PubMed 41117881Mak IEK, Yao Y, Xu Y, Kim JE. Plasma carotenoids and skin carotenoid status response following short-term changes in carotenoid intakes: a randomised clinical trial. Eur J Nutr. 2025 Oct 21;64(8):302. doi: 10.1007/s00394-025-03824-5.
- Derived from this study: PubMed 36921903Yao Y, Yang Z, Yin B, Goh HM, Toh DWK, Kim JE. Effects of dietary fat type and emulsification on carotenoid absorption: a randomized crossover trial. Am J Clin Nutr. 2023 May;117(5):1017-1025. doi: 10.1016/j.ajcnut.2023.03.011. Epub 2023 Mar 13.
- Individual participant dataSharing planned: No
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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.
KIM Jung EUN principal investigator
National University of Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olive oil-water mixture, olive oil-water emulsion and coconut oil-water mixture in people with Carotenoids, run by National University of Singapore at 2 sites 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 3 inclusion and 11 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 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Blood carotenoids concentrations (time frame: Up to 6 months). The study lists 2 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 NCT04323826, which also lists 3 linked publications.
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 10 Sep 2021.