Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices

Healthy Clinical Trial

— Popeye  

Official title:

Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices - a Explorative Study in Short-bowel Patients and Healthy Controls - The "Popeye-study"

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02450227
• Other study ID #: M220
• Secondary ID: H-3-2014-112/464
• Status: Terminated
• Phase: N/A
• First received: May 17, 2015
• Last updated: March 21, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical 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 (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.

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 information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Ileostomy; Functional Disturbance
• Pathologic Processes

Intervention

Dietary Supplement:
• Spinach - Whole leaf (10 mg lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
• Spinach - Minced (10 mg/lutein)
Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Department of Gastroenterology, CA-2121	Copenhagen Ø
Denmark	Department of Nutrition, Exercise and Sports, University of Copenhagen	Frederiksberg C

Sponsors (5)

Lead Sponsor	Collaborator
University of Copenhagen	Agroscope Liebefeld-Posieux Research Station ALP, Glostrup University Hospital, Copenhagen, Herta Messerli Stiftung, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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.	48/24 hours	No
Secondary	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	No
Secondary	Serum concentration of other carotenoids	Difference in serum concentration of other carotenoids between baseline and the end of each intervention period.	15 days	No
Secondary	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	No
Secondary	Changes in metabolic markers	Changes in overall metabolic markers from urine 24 hours postprandial	24 hours	No
Secondary	Changes in metabolic markers	Changes in overall metabolic markers in the chylomicron/TLR fraction 24 hours postprandial	24 hours	No
Secondary	Changes in metabolic markers	Changes in overall metabolic markers in serum at the end of each intervention period.	15 days	No
Secondary	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	No