NCT04323826

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

March 24, 2020

Last Update Submit

September 2, 2021

Conditions

Keywords

Carotenoids absorptionblood triglyceridespostprandial lipid

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

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.

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.

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.

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.

Other: coconut oil-water mixture

Interventions

50% olive oil in water, processed with high shear mixer at 8000 rpm power without adding emulsifier, well shaked before consumption.

salads with olive oil-water mixture

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.

salads with olive oil-water emulsion

50% coconut oil in water, processed with high shear mixer at 8000 rpm power without adding emulsifier, well shaked before consumption.

salads with coconut oil-water mixture

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.

salads with coconut oil-water emulsion

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

Investigational Medical Unit (IMU)

Singapore, 117599, Singapore

Location

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: 26016861BACKGROUND
  • Yao 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.

Study Officials

  • KIM Jung EUN

    National University of Singapore

    PRINCIPAL INVESTIGATOR

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

Locations