Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices

NCT ID: NCT02450227

Last Updated: 2016-03-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

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.

Detailed Description

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. Twenty four participants (12 in each group) will be randomized to two sequences (1-2, 2-1) of interventions with a more and a less bio-accessible spinach preparation (differentiates only on the basis of particle size).

The intervention period is sub-divided into three parts: run-in period (48 hours) with a standardized low-carotenoid diet, 0-24 hours (follow-up period 1 (FP1)) and 24 hours - 2 weeks (FP2). The intervention periods will be separated by a wash-out period of at least 14 days.

At start of each intervention, the intervention meal (breakfast) is served, followed by standardized, carotenoid-free meals in the following 24 hours. Participants will in FP1 and FP2 receive an intervention meal every second day. Participants will otherwise keep their habitual diets during these follow-up periods.

Study participants are asked to collect urine during 24 hours before and after the first intervention meal in each period. They will also collect feces/ileostomy efflux for 24 hours before and after initiation of the intervention for short bowel/ileostomy patients and for 48 periods in the healthy volunteers, respectively. Overnight-fasting serum samples are drawn at day 1, 7 and 15 of each intervention period. On day 1 plasma samples are drawn at 0,1, 3, 4, 6, 7, 9 and 24 hours post first intervention meal.

Plasma and effluent levels of lutein and beta-carotene will be determined and chylomicrons are also separated from these samples for determination of carotenoids.

Volunteers also have their macula examined for density of the yellow spot before and after the intervention. Plasma and effluent levels of other carotenoids as well as fat-soluble vitamins are also determined. The samples will also be subjected to metabolic profiling for further exploration and hypothesis generation.

Conditions

Ileostomy; Functional Disturbance; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Spinach - Whole leaf (10 mg lutein)

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.

Group Type: ACTIVE_COMPARATOR

Spinach - Whole leaf (10 mg lutein)

Intervention Type: DIETARY_SUPPLEMENT

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

Spinach - Minced (10 mg/lutein)

Intervention Type: DIETARY_SUPPLEMENT

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

Spinach - Minced (10 mg lutein)

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.

Group Type: EXPERIMENTAL

Spinach - Whole leaf (10 mg lutein)

Intervention Type: DIETARY_SUPPLEMENT

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

Spinach - Minced (10 mg/lutein)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Spinach - Whole leaf (10 mg lutein)

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

Intervention Type: DIETARY_SUPPLEMENT

Spinach - Minced (10 mg/lutein)

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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)
• Type of disease/background for operation
• Intestinal anatomy (inclusive length and type of residual intestine)
• Type and doses of vitamin and other types of supplementation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agroscope Liebefeld-Posieux Research Station ALP

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Herta Messerli Stiftung

UNKNOWN

Sponsor Role: collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Professor Lars Ove Dragsted

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars O Dragsted, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

Rigshospitalet, Department of Gastroenterology, CA-2121

Copenhagen Ø, , Denmark

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg C, , Denmark

Countries

Denmark

Other Identifiers

H-3-2014-112/46407

Identifier Type: OTHER

Identifier Source: secondary_id

M220

Identifier Type: -

Identifier Source: org_study_id