Effect of the Type and Emulsification of Dietary Fat on the Carotenoids Absorption

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.

Study Overview

• Status: Completed
• Conditions: Carotenoids
• Intervention / Treatment: Other: olive oil-water mixture; Other: olive oil-water emulsion; Other: coconut oil-water emulsion; Other: coconut oil-water mixture

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117546
    • Department of Food Science and Technology; National University of Singapore
  • Singapore, Singapore, 117599
    • Investigational Medical Unit (IMU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ability to give an informed consent
2. Age 19 to 45 years
3. Willing to follow the study procedures

Exclusion Criteria:

1. Significant weight change > 3 kg in the past 3 months;
2. 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);
3. Intestinal disorders including lipid malabsorption;
4. Diabetes or prediabetes (fasting blood glucose > 100 mg/dL);
5. Smoking;
6. Drinking more than 2 alcoholic drinks per day;
7. Taking lipid-lowering medications or dietary supplements affecting plasma lipid-lipoprotein concentration.
8. Menopausal women, those using hormone based contraceptives, those having abnormal menstrual cycles, and those who are pregnant, lactating or planning to become pregnant.
9. Following any restricted diet (e.g. vegetarian)
10. Taking dietary supplements which may impact the outcome of interests (e.g. carotenoids supp.)
11. Insufficient venous access to allow the blood collection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: salads with olive oil-water mixture; 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; 50% olive oil in water, processed with high shear mixer at 8000 rpm power without adding emulsifier, well shaked before consumption.
Experimental: salads with olive oil-water emulsion; 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; 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.
Experimental: salads with coconut oil-water emulsion; 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; 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.
Experimental: salads with coconut oil-water mixture; 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; 50% coconut oil in water, processed with high shear mixer at 8000 rpm power without adding emulsifier, well shaked before consumption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin carotenoid status	Measured using resonance Raman spectroscopy.	Up to 4 months
Height	Height (cm)	Baseline data, up to 4 weeks
Weight	Weight (kg)	Baseline data, up to 4 weeks
Waist circumference	waist circumference (cm)	Baseline data, up to 4 weeks
Diet	Dietary analysis via 3-day food record	Up to 6 months

Collaborators and Investigators

• Sponsor: National University, Singapore
• Collaborators: Clinical Nutrition Research Centre, Singapore
• Investigators: Principal Investigator: KIM Jung EUN, National University, Singapore

Publications and helpful links

General 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. Erratum In: Am J Clin Nutr. 2015 Oct;102(4):981.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Carotenoids absorption; blood triglycerides; postprandial lipid
• Other Study ID Numbers: s10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No