Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices
- Conditions
- Ileostomy; Functional DisturbanceHealthy
- Interventions
- Dietary Supplement: Spinach - Whole leaf (10 mg lutein)Dietary Supplement: Spinach - Minced (10 mg/lutein)
- Registration Number
- NCT02450227
- Lead Sponsor
- University of Copenhagen
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Spinach - Minced (10 mg lutein) Spinach - Whole leaf (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. Spinach - Whole leaf (10 mg lutein) 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. Spinach - Whole leaf (10 mg lutein) Spinach - Minced (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. Spinach - Minced (10 mg lutein) 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.
- Primary Outcome Measures
Name Time Method Serum concentration of lutein and beta-carotene 15 days Difference in serum concentration of lutein and beta-carotene between baseline and the end of each intervention period.
- Secondary Outcome Measures
Name Time Method Concentration of lutein and beta-carotene in the chylomicron/TLR fraction 24 hours 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.
Concentration of other carotenoids in the chylomicron/TLR fraction 24 hours 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.
Level of optical density of the macula lutea Baseline Level of optical density in the macula lutea (MPOD), in the spectra where xanthophyll pigment is absorbing light.
Total lutein and beta-carotene sekretion with feces/ileostomy-efflux 48/24 hours Total lutein and beta-carotene sekretion with feces/ileostomy-efflux 48 and 24 hours postprandial, for healthy and ileostomy patients, respectively.
Serum concentration of other carotenoids 15 days Difference in serum concentration of other carotenoids between baseline and the end of each intervention period.
Serum concentration of other fat-soluble vitamins 15 days Difference in serum concentration of other vitamins (A, E; D, K) between baseline and the end of each intervention period.
Changes in metabolic markers 15 days Changes in overall metabolic markers in serum at the end of each intervention period.
Trial Locations
- Locations (2)
Department of Nutrition, Exercise and Sports, University of Copenhagen
🇩🇰Frederiksberg C, Denmark
Rigshospitalet, Department of Gastroenterology, CA-2121
🇩🇰Copenhagen Ø, Denmark