Effect of the Type and Emulsification of Dietary Fat on the Carotenoids Absorption
1 other identifier
interventional
16
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedSeptember 10, 2021
September 1, 2021
5 months
March 24, 2020
September 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Blood carotenoids concentrations
Five main carotenoids compounds, lutein, zeaxanthin, α-carotene, β-carotene and lycopene concentrations will be determined in blood via HPLC.
Up to 6 months
Blood triglycerides concentrations
Plasma triglyceride concentration will be determined by using a Cobas c311 chemistry analyzer (Roche Diagnostics, Asia Pacific).
Up to 6 months
Secondary Outcomes (5)
Skin carotenoid status
Up to 4 months
Height
Baseline data, up to 4 weeks
Weight
Baseline data, up to 4 weeks
Waist circumference
Baseline data, up to 4 weeks
Diet
Up to 6 months
Study Arms (4)
salads with olive oil-water mixture
EXPERIMENTALVegetable 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
EXPERIMENTALVegetable 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
EXPERIMENTALVegetable 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
EXPERIMENTALVegetable salads (100g tomatoes, 62g carrots, 70g spinach, 25g lettuce and 5g wolfberry) with 56g coconut oil-water mixture will be provided to consume.
Interventions
50% olive oil in water, processed with high shear mixer at 8000 rpm power without adding emulsifier, well shaked before consumption.
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.
50% coconut oil in water, processed with high shear mixer at 8000 rpm power without adding emulsifier, well shaked before consumption.
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.
Eligibility Criteria
You may qualify if:
- Ability to give an informed consent
- Age 19 to 45 years
- Willing to follow the study procedures
You may not qualify if:
- 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;
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Food Science and Technology; National University of Singapore
Singapore, 117546, Singapore
Investigational Medical Unit (IMU)
Singapore, 117599, Singapore
Related Publications (2)
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.
PMID: 26016861BACKGROUNDYao 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.
PMID: 36921903DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
KIM Jung EUN
National University of Singapore
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
March 24, 2020
First Posted
March 27, 2020
Study Start
April 1, 2021
Primary Completion
August 31, 2021
Study Completion
September 1, 2021
Last Updated
September 10, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share