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Gepigmenteerde aardappel studie


- candidate number29659
- NTR NumberNTR7541
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-okt-2018
- Secondary IDsNL66686.081.18 ABR
- Public TitleGepigmenteerde aardappel studie
- Scientific TitleHigh Pigment Potato (Hipp) study:
Assessing the biovailability of lutein/zeaxanthin and exploring the absorption of anthocyanins from high pigment potatoes
- ACRONYMHiPP
- hypothesisPrimary Objective: To assess the bioavailability of lutein and zeaxanthin in high pigment potatoes in humans.

Secondary Objective: To explore the absorption of anthocyanins and to determine the different metabolites in urine and blood plasma, originating from anthocyanins in high pigment potatoes in humans.

Research questions:
• What is the bioavailability of lutein/ zeaxanthin from high pigment potatoes compared to white potatoes supplemented with lutein (FloraGlo supplement) (positive control)?
• What is the absorption of anthocyanins from high pigment potatoes compared to white potatoes?
• What metabolites, originating from anthocyanins, can be identified in the urine after consumption of high pigment potatoes?
- Healt Condition(s) or Problem(s) studiedBioavailability, Potatoes, Carotenoids
- Inclusion criteria• Male
• Age: 18-65 years
• Body Mass Index (BMI) 18-30 kg/m2.
- Exclusion criteria• Recent history of acute gastro-intestinal conditions (indigestion, diarrhoea, constipation) (over last 2 weeks before screening).
• History of gastro-intestinal (atrophic gastritis, gastric and peptic ulcers, small bowel disease or resection, enterocolitis, Crohn’s disease, bleeding disorders) and/or renal diseases (according to research subjects own statement)
• Use of supplements containing anthocyanins or carotenoids (lutein/zeaxanthin) in the last 3 months
• Use of (prescribed) medication during the whole study (excluding painkillers)
• Use of lipid lowering medications in the last 6 months
• Smoking
• Current participation in other studies
• Having a medically prescribed diet
• Working or doing an internship or thesis at the Division of Human Nutrition
• Not having suitable venes for canulation
• Fasting plasma triglycerides outside the normal range (0.8-2.0 mmol/l is normal range used as reference at Hospital Gelderse Vallei).
• Low haemoglobin level (<8.5mmol/l means exclusion)
• Blood donation in the last 3 months before the screening and during the study
• Allergic or hypersensitivity for potato
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2019
- planned closingdate15-feb-2019
- Target number of participants10
- InterventionsTest meals 1, 2 and 3 all weigh 600 grams and contain the same amount of potato mash, salt and oil. Lutein, zeaxanthin and anthocyanin content will vary per test meal, depending on the type of potato variety. The levels will be confirmed through samples taken for analysis on each of the test days.
Test meal 1 will include a mixture of the varieties Inca Sun, H0 00-8108, and Violet queen which is anticipated to provide a total of ~2 mg of lutein plus zeaxanthin, and ~150 mg of anthocyanins (of which the most important are the mainly petunidin-, delphinidin-, pelargonidin-, peonidin-, and malvidin glucosides).
Test meal 2 (negative control) includes a white flesh potato variety (Ivory Russet) containing less than 0.5 mg/kg total carotenoids, but devoid of lutein and zeaxanthin, and anthocyanins.
Test meal 3 (positive control) will contain the white fleshed potato variety Ivory Russet, supplemented with 2 mg highly bioavailable lutein in oil (FloraGLO) obtained from DSM. This supplement has been used before in other studies as a positive control, added as an addition to a food matrix, studying the bioavailability of lutein [52].
Test “meal” 4 will only include the consumption of water, for baseline profiling of anthocyanin metabolites.
- Primary outcomeThe main study endpoints are the bioavailability of lutein and zeaxanthin (determined using the area under the curve) after ingestion of the high pigment potato. These are expressed as a change in the level of lutein and zeaxanthin in the triglyceride rich lipoproteins fractions (TRL) as compared to the bioavailability of the lutein supplement high potato test meal.

These study parameters will be monitored from t=0 to t=9 hrs after consumption of the test meal.
- Secondary outcomeTo explore the absorption of anthocyanins, changes are measured in blood plasma and urine (intact molecules and metabolite excretion products) after consumption of the different test meals. Intact molecules and main metabolites (protocatechuic acid derived, vanillic acid, vanillic acid sulfate, hippuric acid and ferulic acid) will be measured, and metabolic profiling will be used to determine other yet unknown metabolites.

These study parameters will be monitored from t=0 to t=9 hrs after consumption of the test meal.
- TimepointsThe study parameters will be monitored from t=0 to t=9 hrs after consumption of the test meal.
In total four different testdays will take place for each participant
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Marijke Hummel
- CONTACT for SCIENTIFIC QUERIES Marijke Hummel
- Sponsor/Initiator Wageningen University (WUR)
- Funding
(Source(s) of Monetary or Material Support)
Topconsortia voor Kennis en Innovatie (TKI)
- Publications
- Brief summaryRationale: Potatoes (Solanum tuberosum) are the largest non-cereal crop and the fourth most produced staple food crop in the world [2]. In addition to a high content of carbohydrates, proteins and dietary fibre, potatoes are also rich in miconutrients like vitamin C, vitamin B, folate and minerals, such as potassium, magnesium, and iron [3]. Coloured potatoes contain secondary metabolites such as anthocyanins and carotenoids, which are important bioactives [4, 5]. Diets rich in such compounds have been associated with a lower incidence of atherosclerosis, certain cancers, macular degeneration and severity of cataracts [6]. Pigmented potatoes could fit therefore in a healthy lifestyle. Pigmented potatoes contain higher levels of lutein and zeaxanthin (yellow/red color) or anthocyanins (purple color), however limited evidence is available on their bioavailability in humans. Therefore this study was set up as a randomized controlled cross-over study in fasted healthy research subjects on a restricted diet (low in carotenoids/anthocyanins). Research subjects will consume once high pigment potatoes, white potatoes, lutein supplemented white potatoes or water, in random order. Using this approach the bioavailability of lutein and zeaxanthin and the absorption of anthocyanins will be determined.

Objective: The main objective is to assess the bioavailability of lutein, zeaxanthin and to explore the absorption of anthocyanins from high pigment potatoes in humans. In addition, we aim to identify various metabolites in urine, originating from the anthocyanins in the high pigment potatoes.

Study design: Randomized controlled cross-over study
Study population: Ten apparently healthy males, 18-65 years old recruited from the human volunteer database kept at the Division of Human Nutrition.
Intervention:
Test meals consisting of:
1. 600 gram high pigment potato mash with High Oleic Sunflower Oil (HOSO), containing in total 2 mg lutein and zeaxanthin, and 150 mg anthocyanins (mainly mainly petunidin-, delphinidin-, pelargonidin-, peonidin-, and malvidin glucosides)
2. 600 gram white potato mash with HOSO oil (negative control)
3. 600 gram white potato mash with HOSO oil and supplemented with 2 mg lutein (positive control)
4. Only water (blank)
Each research subject will receive each of these test meals in randomized order, with one week in between the different test meals.

Main study parameters/endpoints:
The main study endpoints are the bioavailability of lutein and zeaxanthin and the absorption of anthocyanins. For carotenoids, the level of lutein and zeaxanthin in triglyceride rich lipoproteins fractions (TRL) will be determined of blood sampled on 8 time points per test day [7]. The area under the curve of these carotenoid levels in time will be determined to calculate the bioavailability. For anthocyanins, intact molecules and metabolites will be measured in blood plasma as well as metabolites excreted in urine [8]. These study parameters will be monitored from t=0 to t=9 hrs after consumption of the test meal.
- Main changes (audit trail)
- RECORD10-okt-2018 - 23-okt-2018


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