Ileostomy; Functional DisturbancePopeyeNCT02450227
Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices
A study testing Spinach - Whole leaf (10 mg lutein) and Spinach - Minced (10 mg/lutein) in people with Ileostomy; Functional Disturbance and Healthy, run by University of Copenhagen at 2 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ileostomy; Functional Disturbance, Healthy
- What is being tested?
- Spinach - Whole leaf (10 mg lutein) and Spinach - Minced (10 mg/lutein)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet, Department of Gastroenterology, CA-2121
Copenhagen Ø, 2100
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg C, 1958
About this study
Official title: 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.
Read the 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.
- Conditions
- Ileostomy; Functional Disturbance, Healthy
- Being tested
- Spinach - Whole leaf (10 mg lutein), Spinach - Minced (10 mg/lutein)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Spinach - Minced (10 mg/lutein)Dietary supplement
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Spinach - Whole leaf (10 mg lutein); Dietary Supplement: Spinach - Minced (10 mg/lutein) |
| 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. Receives: Dietary Supplement: Spinach - Whole leaf (10 mg lutein); Dietary Supplement: Spinach - Minced (10 mg/lutein) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 24 hours
Serum concentration of other carotenoids
Difference in serum concentration of other carotenoids between baseline and the end of each intervention period.
Measured: 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.
Measured: 15 days
Changes in metabolic markers
Changes in overall metabolic markers from urine 24 hours postprandial
Measured: 24 hours
Changes in metabolic markers
Changes in overall metabolic markers in the chylomicron/TLR fraction 24 hours postprandial
Measured: 24 hours
Changes in metabolic markers
Changes in overall metabolic markers in serum at the end of each intervention period.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: It is considered non-achievable to recruit the target number of subjects in the short bowel group (n = 12). 10 participants were recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileostomy; Functional DisturbanceStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Agroscope Liebefeld-Posieux Research Station ALP, Copenhagen University Hospital, Rigshospitalet, Herta Messerli Stiftung, Glostrup University Hospital, Copenhagen
- Responsible party
- Principal investigator, Professor Lars Ove Dragsted, University of Copenhagen
- Investigators
- Lars O Dragsted, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450227
- Sponsor's protocol ID
- M220
- Other IDs
- H-3-2014-112/46407
- Acronym
- Popeye
- Status last verified
- Mar 2016
- First submitted
- 17 May 2015
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices - a Explorative Study in Short-bowel Patients and Healthy Controls - The "Popeye-study"
- ClinicalTrials.gov ID
- NCT02450227
- Acronym / sponsor ID
- Popeye / M220
- Conditions
- Ileostomy; Functional Disturbance, Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It is considered non-achievable to recruit the target number of subjects in the short bowel group (n = 12). 10 participants were recruited.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Agroscope Liebefeld-Posieux Research Station ALP, Copenhagen University Hospital, Rigshospitalet, Herta Messerli Stiftung, Glostrup University Hospital, Copenhagen
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinach - Whole leaf (10 mg lutein) | Active comparator | Dietary Supplement: Spinach - Whole leaf (10 mg lutein), Dietary Supplement: 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) | Experimental | 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinach - Whole leaf (10 mg lutein)Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet | Dietary supplement | Spinach - Minced (10 mg lutein), Spinach - Whole leaf (10 mg lutein) |
| Spinach - Minced (10 mg/lutein)Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet | Dietary supplement | Spinach - Minced (10 mg lutein), Spinach - Whole leaf (10 mg lutein) |
Primary outcome
Serum concentration of lutein and beta-carotene
Time frame: 15 days
Difference in serum concentration of lutein and beta-carotene between baseline and the end of each intervention period.
9 secondary outcomes
Concentration of lutein and beta-carotene in the chylomicron/TLR fraction
Time frame: 24 hours
Total lutein and beta-carotene sekretion with feces/ileostomy-efflux
Time frame: 48/24 hours
Concentration of other carotenoids in the chylomicron/TLR fraction
Time frame: 24 hours
Serum concentration of other carotenoids
Time frame: 15 days
Serum concentration of other fat-soluble vitamins
Time frame: 15 days
Changes in metabolic markers
Time frame: 24 hours
Changes in metabolic markers
Time frame: 24 hours
Changes in metabolic markers
Time frame: 15 days
Level of optical density of the macula lutea
Time frame: Baseline
Results and safety
The study was stopped early (reason given: It is considered non-achievable to recruit the target number of subjects in the short bowel group (n = 12). 10 participants were recruited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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Recruiting
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Bowel Dysfunction, Colon Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars O Dragsted, PhD principal investigator
University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinach - Whole leaf (10 mg lutein) and Spinach - Minced (10 mg/lutein) in people with Ileostomy; Functional Disturbance and Healthy, run by University of Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: It is considered non-achievable to recruit the target number of subjects in the short bowel group (n = 12). 10 participants were recruited.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of lutein and beta-carotene (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.