Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices (Popeye)
Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices - a Explorative Study in Short-bowel Patients and Healthy Controls - The "Popeye-study"
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Copenhagen Ø、デンマーク、2100
- Rigshospitalet, Department of Gastroenterology, CA-2121
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Frederiksberg C、デンマーク、1958
- Department of Nutrition, Exercise and sports, University of Copenhagen
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
List of 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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. |
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
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実験的：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. |
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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Serum concentration of lutein and beta-carotene
時間枠：15 days
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Difference in serum concentration of lutein and beta-carotene between baseline and the end of each intervention period.
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15 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Concentration of lutein and beta-carotene in the chylomicron/TLR fraction
時間枠：24 hours
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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.
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24 hours
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Total lutein and beta-carotene sekretion with feces/ileostomy-efflux
時間枠：48/24 hours
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Total lutein and beta-carotene sekretion with feces/ileostomy-efflux 48 and 24 hours postprandial, for healthy and ileostomy patients, respectively.
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48/24 hours
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Concentration of other carotenoids in the chylomicron/TLR fraction
時間枠：24 hours
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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.
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24 hours
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Serum concentration of other carotenoids
時間枠：15 days
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Difference in serum concentration of other carotenoids between baseline and the end of each intervention period.
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15 days
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Serum concentration of other fat-soluble vitamins
時間枠：15 days
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Difference in serum concentration of other vitamins (A, E; D, K) between baseline and the end of each intervention period.
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15 days
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Changes in metabolic markers
時間枠：24 hours
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Changes in overall metabolic markers from urine 24 hours postprandial
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24 hours
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Changes in metabolic markers
時間枠：24 hours
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Changes in overall metabolic markers in the chylomicron/TLR fraction 24 hours postprandial
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24 hours
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Changes in metabolic markers
時間枠：15 days
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Changes in overall metabolic markers in serum at the end of each intervention period.
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15 days
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Level of optical density of the macula lutea
時間枠：Baseline
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Level of optical density in the macula lutea (MPOD), in the spectra where xanthophyll pigment is absorbing light.
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Baseline
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- M220
- H-3-2014-112/46407 (その他の識別子：The Danish Ethics Committee)
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