Influence of Proteins on the Bioavailability of Carotenoids

NCT04078646 | Completed

• 1 other identifier: 201710/04
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Absorption; Chemicals; Healthy Diet; Metabolism

Keywords

Carotenoids; Postprandial absorption; Area-under-curve; Bioavailability; Proteins; Tomato juice; Carrot juice; Randomized cross-over

Outcome Measures

Primary Outcomes (1)

• Concentration of carotenoids in plasma triacyl-rich-lipoprotein (TRL) fraction

  Carotenoid concentration (lycopene, beta-carotene) studied over 10 hours postprandial (area-under curve of concentration vs. time)

  10 hours postprandial, measured on 3 test clinical test days after test meal intake, interspersed by 1 week each

Secondary Outcomes (3)

• Time of maximum concentration of lycopene and beta-carotene and triglycerides in plasma-TRL fraction

  10 hours postprandial, measured on 3 clinical test days after test meal intake, interspersed by 1 week

• Maximum concentration of lycopene and beta-carotene and triglycerides in plasma-TRL fraction

  10 hours postprandial, measured on 3 test clinical days after test meal intake, interspersed by 1 week

• Fecal degradation products of carotenoids

  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

Study Arms (3)

Dietary intervention

EXPERIMENTAL

Intervention with test meal only

Other: Intervention without protein addition

Dietary intervention 2

EXPERIMENTAL

Intervention with test meal and whey protein isolate (30 g)

Other: Intervention with whey protein

Dietary intervention 3

EXPERIMENTAL

Intervention with test meal and soy protein (30 g)

Other: Intervention with soy protein isolate

Interventions

Intervention with soy protein isolate OTHER

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.

Dietary intervention 3

Intervention with whey protein OTHER

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.

Dietary intervention 2

Intervention without protein addition OTHER

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.

Dietary intervention

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Only self-declared men will participate in the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• Laboratoires Réunis: collaborator
• Université Catholique de Louvain: collaborator
• Luxembourg Institute of Science and Technology: collaborator

Study Sites (1)

Luxembourg Institute of Health

Strassen, 1445, Luxembourg

Location

Related Publications (3)

• Iddir M, Degerli C, Dingeo G, Desmarchelier C, Schleeh T, Borel P, Larondelle Y, Bohn T. Whey protein isolate modulates beta-carotene bioaccessibility depending on gastro-intestinal digestion conditions. Food Chem. 2019 Sep 1;291:157-166. doi: 10.1016/j.foodchem.2019.04.003. Epub 2019 Apr 1.

  PMID: 31006454 BACKGROUND

• Soukoulis C, Bohn T. A comprehensive overview on the micro- and nano-technological encapsulation advances for enhancing the chemical stability and bioavailability of carotenoids. Crit Rev Food Sci Nutr. 2018 Jan 2;58(1):1-36. doi: 10.1080/10408398.2014.971353. Epub 2017 Jul 5.

  PMID: 26065668 BACKGROUND

• Corte-Real J, Guignard C, Gantenbein M, Weber B, Burgard K, Hoffmann L, Richling E, Bohn T. No influence of supplemental dietary calcium intake on the bioavailability of spinach carotenoids in humans. Br J Nutr. 2017 Jun;117(11):1560-1569. doi: 10.1017/S0007114517001532. Epub 2017 Jun 27.

  PMID: 28651681 RESULT

Related Links

• Description of study
• Funding information

MeSH Terms

Interventions

Methods; Soybean Proteins; Whey Proteins

Intervention Hierarchy (Ancestors)

Investigative Techniques; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Milk Proteins; Animal Proteins, Dietary; Whey; Milk; Dairy Products

Study Officials

• Torsten Bohn, PhD

  Luxembourg Institute of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: September 6, 2019
• Study Start: October 11, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1)