Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices - a Explorative Study in Short-bowel Patients and Healthy Controls - The "Popeye-study"
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Serum concentration of lutein and beta-carotene
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •List of 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).
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: Spinach - Whole leaf (10 mg lutein) (Dietary Supplement)
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.
干预措施: Spinach - Minced (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.
干预措施: 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.
干预措施: Spinach - Minced (10 mg/lutein) (Dietary Supplement)
结局指标
主要结局
Serum concentration of lutein and beta-carotene
时间窗: 15 days
Difference in serum concentration of lutein and beta-carotene between baseline and the end of each intervention period.
次要结局
- Concentration of lutein and beta-carotene in the chylomicron/TLR fraction(24 hours)
- Concentration of other carotenoids in the chylomicron/TLR fraction(24 hours)
- Level of optical density of the macula lutea(Baseline)
- Total lutein and beta-carotene sekretion with feces/ileostomy-efflux(48/24 hours)
- Serum concentration of other carotenoids(15 days)
- Serum concentration of other fat-soluble vitamins(15 days)
- Changes in metabolic markers(15 days)
- Changes in metabolic markers(24 hours)
研究者
Professor Lars Ove Dragsted
Professor
University of Copenhagen