Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices

NCT02450227 | Terminated

• 2 other identifiers: M220H-3-2014-112/46407
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

Absorption and metabolism of carotenoids from two types of spinach preparations will be investigated in two study groups, short bowel/ileostomy and healthy, respectively. The study will be conducted as a randomised, controlled, 2-way crossover study in 24 participants (12 in each group), randomized to two sequences (1-2, 2-1) of interventions with a more and a less bio-accessible spinach preparation. The serum, chylomicron and fecal/effluent levels of lutein and beta-carotene will be determined.

Conditions

Ileostomy; Functional Disturbance; Healthy

Outcome Measures

Primary Outcomes (1)

• Serum concentration of lutein and beta-carotene

  Difference in serum concentration of lutein and beta-carotene between baseline and the end of each intervention period.

  15 days

Secondary Outcomes (9)

• Concentration of lutein and beta-carotene in the chylomicron/TLR fraction

  24 hours

• Total lutein and beta-carotene sekretion with feces/ileostomy-efflux

  48/24 hours

• Concentration of other carotenoids in the chylomicron/TLR fraction

  24 hours

• Serum concentration of other carotenoids

  15 days

• Serum concentration of other fat-soluble vitamins

  15 days

Study Arms (2)

Spinach - Whole leaf (10 mg lutein)

ACTIVE COMPARATOR

1-2: Group given whole leaf as first intervention Whole leaf spinach (10 mg lutein) given every second day for a 15 days period. Followed by: Minced spinach (10 mg lutein) given every second day for a 15 days period.

Dietary Supplement: Spinach - Whole leaf (10 mg lutein); Dietary Supplement: Spinach - Minced (10 mg/lutein)

Spinach - Minced (10 mg lutein)

EXPERIMENTAL

2-1: Group given minced spinach as first intervention Minced spinach (10 mg lutein) given every second day for a 15 days period. Followed by: Whole leaf spinach (10 mg lutein) given every second day for a 15 days period.

Dietary Supplement: Spinach - Whole leaf (10 mg lutein); Dietary Supplement: Spinach - Minced (10 mg/lutein)

Interventions

Spinach - Whole leaf (10 mg lutein) DIETARY_SUPPLEMENT

Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet

Spinach - Minced (10 mg lutein); Spinach - Whole leaf (10 mg lutein)

Spinach - Minced (10 mg/lutein) DIETARY_SUPPLEMENT

Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet

Spinach - Minced (10 mg lutein); Spinach - Whole leaf (10 mg lutein)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults (18-80 years old)
• Body Mass Index (BMI) between 18,9-28
• Normal fasting blood glucose (BS) (1,9-5,6 mmol/L)
• Tolerates: Potatoes, rice, chicken, meat (non vegan/vegetarian).

You may not qualify if:

• Intestinal diseases (among healthy controls), systemic infections, psychiatric disorders, metabolic diseases (incl. diabetes), and any clinical condition/circumstance which assessed by the study official makes the person unfit for participation in the trial.
• Patients diagnosed with short bowel syndrome (SBS).
• Chronic or frequent use of medication. Primarily consumption of drugs with known effect/side effects on fat absorption. Further, anticoagulants (Marevan) and systemic treatment with glucocorticoids.
• Have or have had a drug addiction
• Smokers
• Alcohol consumption beyond the recommended (7/14 units per week for women/men, respectively)
• Intake of vitamins or other supplements (3 months before the study and during the study) (healthy controls). Subjects from the patient group included only with stable intake of dietary supplements through the last 3 months.
• Sampling or donation of larger amount of blood e.g. as blood donors or to other scientific experiments from 3 months before the study until its completion.
• allergy or intolerance to any of the foods included in the study.
• Women who are nursing, pregnant or planning pregnancy
• Not able to comply with the procedures protocol.
• Macular degeneration to a degree greeter than or equal to a surface area with one or more drusen larger than 125 microns in diameter in at least one eye.
• Cataracts, macular- or other ocular disease, preventing depiction of xanthophyll pigment.
• The following separate registered information was additionally recorded for short bowel/ileostomy patients:
• Time since operation (stable, \>1 year post operation)

Sponsors & Collaborators

• University of Copenhagen: lead
• Agroscope Liebefeld-Posieux Research Station ALP: collaborator
• Rigshospitalet, Denmark: collaborator
• Herta Messerli Stiftung: collaborator
• Glostrup University Hospital, Copenhagen: collaborator

Study Sites (2)

Rigshospitalet, Department of Gastroenterology, CA-2121

Copenhagen Ø, 2100, Denmark

Location

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg C, 1958, Denmark

Location

MeSH Terms

Interventions

Lutein

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Lars O Dragsted, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2015
• First Posted: May 21, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

DK (2)