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| ID | Type | Description | Link |
|---|---|---|---|
| H-3-2014-112/46407 | Other Identifier | The Danish Ethics Committee |
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It is considered non-achievable to recruit the target number of subjects in the short bowel group (n = 12). 10 participants were recruited.
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| Name | Class |
|---|---|
| Agroscope Liebefeld-Posieux Research Station ALP | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Herta Messerli Stiftung | UNKNOWN |
| Glostrup University Hospital, Copenhagen |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Total lutein and beta-carotene sekretion with feces/ileostomy-efflux |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Lars O Dragsted, PhD | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, Department of Gastroenterology, CA-2121 | Copenhagen Ø | 2100 | Denmark | |||
| Department of Nutrition, Exercise and Sports, University of Copenhagen |
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| ID | Term |
|---|---|
| D014975 | Lutein |
| ID | Term |
|---|---|
| D024341 | Xanthophylls |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| OTHER |
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| Spinach - Minced (10 mg/lutein) | Dietary Supplement | Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet |
|
Total lutein and beta-carotene sekretion with feces/ileostomy-efflux 48 and 24 hours postprandial, for healthy and ileostomy patients, respectively. |
| 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. | 24 hours |
| Serum concentration of other carotenoids | Difference in serum concentration of other carotenoids between baseline and the end of each intervention period. | 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. | 15 days |
| Changes in metabolic markers | Changes in overall metabolic markers from urine 24 hours postprandial | 24 hours |
| Changes in metabolic markers | Changes in overall metabolic markers in the chylomicron/TLR fraction 24 hours postprandial | 24 hours |
| Changes in metabolic markers | Changes in overall metabolic markers in serum at the end of each intervention period. | 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. | Baseline |
| Frederiksberg C |
| 1958 |
| Denmark |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |