An interventional study of Spinach - Whole leaf (10 mg lutein) and Spinach - Minced (10 mg/lutein) in Ileostomy; Functional Disturbance and Healthy, sponsored by University of Copenhagen. Terminated at 2 sites in Denmark. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-22.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Basic science
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.
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.
University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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List of inclusion criteria:
List of exclusion criteria:
The following separate registered information was additionally recorded for short bowel/ileostomy patients:
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)
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)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
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.
Time frame: 15 days
Concentration of lutein and beta-carotene in the chylomicron/TLR fraction
Changes in concentration of lutein and beta-carotene in the chylomicron/TLR fraction (area under the curve, AUC) 24 hours post first intervention meal in each intervention periods.
Time frame: 24 hours
Total lutein and beta-carotene sekretion with feces/ileostomy-efflux
Total lutein and beta-carotene sekretion with feces/ileostomy-efflux 48 and 24 hours postprandial, for healthy and ileostomy patients, respectively.
Time frame: 48/24 hours
Concentration of other carotenoids in the chylomicron/TLR fraction
Changes in concentration of other carotenoids in the chylomicron/TLR fraction (area under the curve, AUC) 24 hours post first intervention meal in each intervention periods.
Time frame: 24 hours
Serum concentration of other carotenoids
Difference in serum concentration of other carotenoids between baseline and the end of each intervention period.
Time frame: 15 days
Serum concentration of other fat-soluble vitamins
Difference in serum concentration of other vitamins (A, E; D, K) between baseline and the end of each intervention period.
Time frame: 15 days
Changes in metabolic markers
Changes in overall metabolic markers from urine 24 hours postprandial
Time frame: 24 hours
Changes in metabolic markers
Changes in overall metabolic markers in the chylomicron/TLR fraction 24 hours postprandial
Time frame: 24 hours
Changes in metabolic markers
Changes in overall metabolic markers in serum at the end of each intervention period.
Time frame: 15 days
Level of optical density of the macula lutea
Level of optical density in the macula lutea (MPOD), in the spectra where xanthophyll pigment is absorbing light.
Time frame: Baseline
This study is terminated, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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