Effects of Kale Ingredients on Lipid Status ParameterHypocholKaleNCT03545555
Investigations on the Effect of Kale on the Lipid Status
A study testing Kale Preparation "Kale Powder", Kale Preparation "Kale Extract" and Kale Preparation "Flavonoid Extract" in people with Effects of Kale Ingredients on Lipid Status Parameter, run by University of Jena at 1 site in Germany.
Trial summary
This intervention study investigates the effects of various kale preparations (dietary supplements) on lipid status parameters. Within the study period of 8 weeks, three blood withdrawals are planned (week 0, 4 and 8) for the volunteers. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effects of Kale Ingredients on Lipid Status Parameter
- What is being tested?
- Kale Preparation "Kale Powder", Kale Preparation "Kale Extract" and Kale Preparation "Flavonoid Extract"
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 13 Apr 2018to Dec 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- total cholesterol > 200 mg/dl
Who cannot join
- LDL cholesterol < 130 mg/dl
- medication to lower blood lipids
- genetically based hypercholesterolemia
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Friedrich Schiller University, Institute iof Nutritional Science
Jena, Thuringia, 07743
Volker Boehm, PD Dr., +(49)3641/949633, volker.boehm@uni-jena.de
About this study
Official title: Investigations on the Effect of Kale on the Lipid Status (Untersuchungen Zum Einfluss Von Grünkohl Auf Den Lipidstatus)
This intervention study investigates the effects of various kale preparations (dietary supplements) on lipid status parameters. Within the study period of 8 weeks, three blood withdrawals are planned (week 0, 4 and 8) for the volunteers. Lipid status parameters (total cholesterol, HDL cholesterol, LDL cholesterol, triacylglycerides) will be determined in blood. There is a correlation between contents of LDL cholesterol, total cholesterol and triacylglycerides and the risk for cardiovascular diseases (CVD). In contrast, a high content of HDL cholesterol is correlated with a lower risk for CVD. In addition, the contents of apolipoprotein A1 and apolipoprotein B will be analysed.
- Being tested
- Kale Preparation "Kale Powder", Kale Preparation "Kale Extract", Kale Preparation "Flavonoid Extract", Placebo
- Keywords
- kale, antioxidant capacity, cholesterol, lipid status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kale Preparation "Kale Powder"Dietary supplement
Effect of kale preparation kale powder on lipid status
Kale Preparation "Kale Extract"Dietary supplement
Effect of kale preparation kale extract on lipid status
Kale Preparation "Flavonoid Extract"Dietary supplement
Effect of kale preparation flavonoid extract on lipid status
PlaceboDietary supplement
Effect of placebo on lipid status
| Study group | Role | What they receive |
|---|---|---|
| Kale Powder | Experimental | 5 capsules with kale preparation "kale powder" per day for 8 weeks Receives: Dietary Supplement: Kale Preparation "Kale Powder" |
| Kale Extract | Experimental | 5 capsules with kale preparation "kale extract" per day for 8 weeks Receives: Dietary Supplement: Kale Preparation "Kale Extract" |
| Flavonoid Extract | Experimental | 5 capsules with kale preparation "flavonoid extract" (from kale) per day for 8 weeks Receives: Dietary Supplement: Kale Preparation "Flavonoid Extract" |
| Placebo | Placebo comparator | 5 capsules with "placebo" per day for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of lipid status parameters
total cholesterol, HDL cholesterol, LDL cholesterol
Measured: weeks 0, 4 and 8
Secondary outcomes (2)
Change of apolipoproteins
apolipoprotein A1 and apolipoprotein B
Measured: weeks 0, 4 and 8
Change of antioxidant capacity
lipophilic antioxidant capacity (L-TEAC)
Measured: weeks 0, 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start13 Apr 2018
- Primary completionSep 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Kale Ingredients on Lipid Status ParameterStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volker Boehm, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545555
- Sponsor's protocol ID
- AGBAP2018-1
- Acronym
- HypocholKale
- Status last verified
- May 2018
- First submitted
- 7 May 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations on the Effect of Kale on the Lipid Status (Untersuchungen Zum Einfluss Von Grünkohl Auf Den Lipidstatus)
- ClinicalTrials.gov ID
- NCT03545555
- Acronym / sponsor ID
- HypocholKale / AGBAP2018-1
- Keywords
- kale, antioxidant capacity, cholesterol, lipid status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 Jun 2018 (actual)
- 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.
This intervention study investigates the effects of various kale preparations (dietary supplements) on lipid status parameters. Within the study period of 8 weeks, three blood withdrawals are planned (week 0, 4 and 8) for the volunteers. Lipid status parameters (total cholesterol, HDL cholesterol, LDL cholesterol, triacylglycerides) will be determined in blood. There is a correlation between contents of LDL cholesterol, total cholesterol and triacylglycerides and the risk for cardiovascular diseases (CVD). In contrast, a high content of HDL cholesterol is correlated with a lower risk for CVD. In addition, the contents of apolipoprotein A1 and apolipoprotein B will be analysed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Kale Powder | Experimental | Dietary Supplement: Kale Preparation "Kale Powder"5 capsules with kale preparation "kale powder" per day for 8 weeks |
| Kale Extract | Experimental | Dietary Supplement: Kale Preparation "Kale Extract"5 capsules with kale preparation "kale extract" per day for 8 weeks |
| Flavonoid Extract | Experimental | Dietary Supplement: Kale Preparation "Flavonoid Extract"5 capsules with kale preparation "flavonoid extract" (from kale) per day for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo5 capsules with "placebo" per day for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- total cholesterol > 200 mg/dl
Key exclusion criteria (3 listed)
- LDL cholesterol < 130 mg/dl
- medication to lower blood lipids
- genetically based hypercholesterolemia
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 |
|---|---|---|
| Kale Preparation "Kale Powder"Effect of kale preparation kale powder on lipid status | Dietary supplement | Kale Powder |
| Kale Preparation "Kale Extract"Effect of kale preparation kale extract on lipid status | Dietary supplement | Kale Extract |
| Kale Preparation "Flavonoid Extract"Effect of kale preparation flavonoid extract on lipid status | Dietary supplement | Flavonoid Extract |
| PlaceboEffect of placebo on lipid status | Dietary supplement | Placebo |
Primary outcome
Change of lipid status parameters
Time frame: weeks 0, 4 and 8
total cholesterol, HDL cholesterol, LDL cholesterol
2 secondary outcomes
Change of apolipoproteins
Time frame: weeks 0, 4 and 8
Change of antioxidant capacity
Time frame: weeks 0, 4 and 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kale Preparation "Kale Powder", Kale Preparation "Kale Extract" and Kale Preparation "Flavonoid Extract" in people with Effects of Kale Ingredients on Lipid Status Parameter, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Volker Böhm, PD Dr. (+49-(0)3641-9496 ext. 33, Volker.Boehm@uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of lipid status parameters (time frame: weeks 0, 4 and 8). 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 4 Jun 2018.