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Influence of Proteins on the Bioavailability of Carotenoids (CAROPROT)

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ClinicalTrials.gov Identifier: NCT04078646
Recruitment Status : Recruiting
First Posted : September 5, 2019
Last Update Posted : November 7, 2019
Sponsor:
Collaborators:
Laboratoires Réunis
Université Catholique de Louvain
Luxembourg Institute of Science and Technology
Information provided by (Responsible Party):
Luxembourg Institute of Health

Tracking Information
First Submitted Date  ICMJE August 8, 2019
First Posted Date  ICMJE September 5, 2019
Last Update Posted Date November 7, 2019
Actual Study Start Date  ICMJE October 11, 2019
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2019)
Concentration of carotenoids in plasma triacyl-rich-lipoprotein (TRL) fraction [ Time Frame: 10 hours postprandial, measured on 3 test clinical test days after test meal intake, interspersed by 1 week each ]
Carotenoid concentration (lycopene, beta-carotene) studied over 10 hours postprandial (area-under curve of concentration vs. time)
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2019)
Concentration of carotenoids in plasma-triacyl-rich-lipoprotein fraction [ Time Frame: 10 hours postprandial, measured on 3 test clinical test days after test meal intake, interspersed by 1 week each ]
Carotenoid concentration (lycopene, beta-carotene) studied over 10 hours postprandial (area-under curve of concentration vs. time)
Change History Complete list of historical versions of study NCT04078646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2019)
  • Time of maximum concentration of lycopene and beta-carotene and triglycerides in plasma-TRL fraction [ Time Frame: 10 hours postprandial, measured on 3 clinical test days after test meal intake, interspersed by 1 week ]
    Studying the timely appearance of carotenoids in the plasma TRL fraction, i.e. the time when concentration with reach a maximum
  • Maximum concentration of lycopene and beta-carotene and triglycerides in plasma-TRL fraction [ Time Frame: 10 hours postprandial, measured on 3 test clinical days after test meal intake, interspersed by 1 week ]
    Studying the maximum concentration of lycopene and beta-carotene in the plasma-TRL fraction, i.e. the maximum concentration reached during the 10 h monitoring
  • Fecal degradation products of carotenoids [ Time Frame: Collection covering the test meal intake period, starting from the excretion of a brilliant blue capsule taken the 12 hours before test meal intake, until complete excretion of a second brilliant blue capsule taken 24 hours after test meal intake ]
    Studying native carotenoids and degradation products in pooled stool excreted following test meal intake (fecal balance method), i.e. the stool collected following test meal intake
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Proteins on the Bioavailability of Carotenoids
Official Title  ICMJE Influence of Proteins on the Bioavailability of Carotenoids
Brief Summary A postprandial intervention study is conducted on healthy male subjects to evaluate whether the addition of proteins (why protein isolate, soy protein) can help to increase the bioavailability of carotenoids from a tomato/carrot beverage.
Detailed Description

Participants who agree to sign the Informed Consent Form and are considered eligible for participation will be scheduled for a first and brief screening visit enrolment visit) to collect a spot urine and blood sample (20 ml) that are meant to check the subjects anemic status and analyze the sugar levels as well as plasma lipids such as triglycerides, in order to screen for any abnormal health condition (e.g. onset of diabetes) that they might not be aware of at the date of the information session and that might not make them eligible for this study.

If at this stage they are still considered eligible for the study, participants will commence the 4 week trial phase which includes 3 washout periods, 1 short screening visit and 3 full day (i.e. 10.5 hours) clinical visits. The screening visit, called preliminary visit, will take place at the beginning of the trial phase. A blood sample will be collected to determine the baseline levels of triglycerides and plasma carotenoids at the beginning of the trial, prior to the first washout phase.

The first washout week starts on day 1 after the preliminary visit and will have a duration of 14 days during which the participants will be asked to stay on a low carotenoid diet (i.e. to avoid the intake of colored fruits and vegetables), to reduce the basal levels of blood circulating carotenoids.

During the 1-day appointments at the Clinical and Epidemiological Investigation Centre (CIEC), one of the three test meals will be given to the participants in 6 different orders, making 6 treatment patterns. Assuming that all 24 participants are successfully recruited, we will have 4 randomly allocated participants per pattern.

On clinical visit days, participants will be asked to report at the CIEC's facilities, starting from 7:30 am, and a baseline blood sample (20 ml) will be drawn at 0h time point. A trained nurse will insert a cannula in the forearm of the participant that will be left in place during the whole staying for the commodity of the participant.

Immediately after the baseline blood draw, a test meal composed of a mixture of carrot and tomato juice (350 mL in total), to which 5 mL of peanut oil will be added, 40 g of toasted bread (white wheat, with 10 g margarine plus 20 g cream-cheese) and a glass of water (approx. 300 mL) which may or may not contain 30 g of proteins (either a plant based protein or a dairy-based proteins) will be served. The entire test meal must be eaten within 30 min, under supervision.

Post-prandial blood samples (20 ml each) will be collected at timed intervals (before, 2h, 3h, 4h, 5h. 6h, 8h and 10h after test meal intake). Participants will receive a standardized lunch 4 hours after test meal intake (c.a. 12:00 pm), consisting of a toasted sandwich (white wheat bread, ca 60 g), with ca. 60 g turkey with some margarine to spread on the bread (ca 10 g), a Greek yogurt (140 g) and a small apple. A courtesy meal 10 hours after test meal intake for dinner and at the end of the visit. No other foods or beverages except water (ad libitum) will be allowed during the day (including during breakfast and lunch if desired).

This first clinical appointment will be followed by a 1 week washout period, during which he/she will continue on a low carotenoid diet (3rd week of washout diet). At the end of the 3rd week of washout, the second appointment at the LIH clinical center will take place. The procedure for this day is the same as mentioned above. The second appointment is followed by the 4th and last washout week and at the end the participant will have the 3rd and last appointment at the Luxembourg Institute of Health (LIH) clinical center, which will be identical to the other visits. For all washout periods the participants will be asked to fill a provided food journal, on a daily basis, where they will write down what they have eaten during the day. This will be used to check compliance with the washout period and better interpret personal data.

Stool collection: For a limited number of subjects (n=6), the samples will be collected following intake of all 3 test meals. For this purpose, Containers for collection and plastic clip-bags and bags will be handed to participants. Boxes with cooling elements for stool collection will likewise be given. Also, six fecal color markers will be provided to the participants. For each clinical visit, two fecal marker are needed. Collections will start from the excretion of the first fecal color marker (brilliant blue) which will be taken at the beginning of the fasting period, i.e. the day before each clinical day. The collection will continue to the excretion of the second fecal marker which should be taken on the morning of the day following each clinical visit (before breakfast). Samples will be returned after the clinical test day as soon as the last fecal marker has been excreted (normally resulting in 2-3 day complete fecal samples), and could be collected once in between by staff from the LIH if needed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Twenty four male individuals from or living in the region of Luxembourg will be recruited for this study. The number of participants is based on a randomized block design, constituting of 6 blocks of 4 subjects, each will be served different sequences of test meals (A, B, C/A, C, B/B, C, A/B, A, C/C, A, B/C, B, A) in order to cancel out any potential effect of sequence of meals.

Thus, each subject will act has his/her own control. Test meal intake will be separated by 1 week.

Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Absorption; Chemicals
  • Healthy Diet
  • Metabolism
Intervention  ICMJE
  • Other: Intervention with soy protein isolate

    Test meals will be served to the subjects, containing soy protein isolate:

    350 mL carrot/tomato juice (50:50, v/v), with 30 g added soy protein, plus 5 ml peanut oil

    as morning test meal, served together with 40 g toasted bread and 20 g of cream-cheese plus 10 g margarine.

  • Other: Intervention with whey protein

    Test meals will be served to the subjects, containing soy protein isolate:

    350 mL carrot/tomato juice (50:50, v/v), with 30 g added whey protein isolate, plus 5 ml peanut oil

    as morning test meal, served together with 40 g toasted bread and 20 g of cream-cheese plus 10 g margarine.

  • Other: Intervention without protein addition

    Test meals will be served to the subjects, containing soy protein isolate:

    350 mL carrot/tomato juice (50:50, v/v), plus 5 ml peanut oil

    as morning test meal, served together with 40 g toasted bread and 20 g of cream-cheese plus 10 g margarine.

Study Arms  ICMJE
  • Experimental: Dietary intervention
    Intervention with test meal only
    Intervention: Other: Intervention without protein addition
  • Experimental: Dietary intervention 2
    Intervention with test meal and whey protein isolate (30 g)
    Intervention: Other: Intervention with whey protein
  • Experimental: Dietary intervention 3
    Intervention with test meal and soy protein (30 g)
    Intervention: Other: Intervention with soy protein isolate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 2, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy and free living;
  • men;
  • age between 20 and 50 years old;
  • Body-Mass-Index (BMI) <30 kg/m2
  • non-smokers (abstinent for more than 2 years);

Exclusion Criteria:

  • suffering from any metabolic disease that may cause digestive disturbances (such as Crohn's disease or colitis);
  • malabsorption disorders;
  • BMI over 30 kg/m2;
  • hyperlipidaemia (triglycerides and total cholesterol over 200 mg/dl)
  • any individuals following a special diet that is not compatible with wash-out periods or test meals (vegetarian, gluten-free or diabetic);
  • regular consumption of more than 5 portions (80-100 g) of fruits and vegetables per day;
  • being on medical treatment or consuming any medication for chronic conditions or recent illness (e.g. antibiotics);
  • consuming regularly dietary supplements;
  • abnormally high or low values of plasma circulating carotenoids;
  • tobacco smoking;
  • frequent alcohol consumption (over 2 glasses per day);
  • food allergies or intolerances that are not compatible with test meals (e.g. gluten or milk intolerance);
  • daily practice of intense physical activity of 120 min or more.

No special population group such as prisoners, children, the mentally disabled or groups whose ability to give voluntary informed consent may be in question, will be recruited for this study.

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Only self-declared men will participate in the study
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Torsten Bohn, PhD +352-621-216-637 torsten.bohn@gmx.ch
Contact: Manon Gantenbein, PhD +352-26970-807 manon.gantenbein@lih.lu
Listed Location Countries  ICMJE Luxembourg
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04078646
Other Study ID Numbers  ICMJE 201710/04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Data of subjects will not be available for outside researchers.
Responsible Party Luxembourg Institute of Health
Study Sponsor  ICMJE Luxembourg Institute of Health
Collaborators  ICMJE
  • Laboratoires Réunis
  • Université Catholique de Louvain
  • Luxembourg Institute of Science and Technology
Investigators  ICMJE
Principal Investigator: Torsten Bohn, PhD Luxembourg Institute of Health
PRS Account Luxembourg Institute of Health
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP