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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03983603
Other study ID # METC 18-064
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 29, 2019
Est. completion date September 2024

Study information

Verified date February 2024
Source Maastricht University Medical Center
Contact Jogchum Plat, PhD
Phone +31433881309
Email j.plat@maastrichtuniversity.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Plant stanols are known to lower low-density lipoprotein cholesterol. However, studies have suggested that these compounds also influence the immune system. Asthmatic responses are predominantly T helper (Th)2 cell dependent, while plant stanols were previously found to activate Th1 cells and shift the immune response away from the Th2 cell dominant asthmatic response. The question now is whether this also translates into a reduction of clinical symptoms in asthma patients.The primary objective of this study is to demonstrate clinical benefits of prolonged consumption of plant stanols (delivered via plant stanol esters) in asthma patients. The secondary objectives are to evaluate the mechanisms via which plant stanols modulate the immune system and to evaluate the effects of plant stanol ester consumption on cardiovascular (CVD) risk parameters.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Diagnosed with allergic asthma (GINA step 1-4) which is in a stable phase at the moment of inclusion (defined as no changes in asthma control and lung function in (at least) the past three months) - Have been treated with prescribed asthma medication for at least one year - Aged 18-70 years old - BMI between 20 and 35 kg/m2 - Willing to abstain from products containing plant sterols or stanols one month prior to the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands) - Willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands) - Willing to keep the intake of fish oil supplements constant Exclusion Criteria: - Currently smoking or quitted smoking in the past year, with a maximum of 10 packyears as smoking history (packyears = packs per day * years of smoking) - Allergy to an ingredient of the soft chews - Suffering from inflammatory diseases (for CVD, illness must be minimally 3 years ago and currently under control in order to participate in the study) - Fasting plasma glucose > 7.0 mmol/L - Fasting serum TC > 8.0 mmol/L - Having donated blood within one month prior to the start of the study, or planning to donate blood during the study - Pregnant women - Breastfeeding women

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Soft chews containing 0.5g plant stanols (delivered as plant stanol esters)
Soft chews containing 0.5g plant stanols delivered as plant stanol esters
Placebo soft chew
Soft chew that does not contain plant stanols

Locations

Country Name City State
Netherlands Maastricht University Medical Center Maastricht Limburg

Sponsors (3)

Lead Sponsor Collaborator
Maastricht University Medical Center Raisio Group, TKI Life Sciences and Health (LSH)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Mechanistic outcomes for measuring the immune response Vaccination response to vaccines against tetanus, pneumococcal bacteria and rabies Weekly from T=12 months to T=13 months
Primary Asthma control questionnaire score The ACQ consists of seven questions: five questions are on asthma related symptoms, one on medication use and one on the FEV1. Participants are asked to score their symptoms and medication use of the past week on a scale from zero to six. The score of the ACQ is the average score on the seven questions. A score of zero means that asthma is fully controlled; a score of six means that asthma is severely uncontrolled. The minimal clinically important difference is 0.5. The ACQ has been validated and is widely use in research and clinical settings. Change between T=0 months and T=12 months
Secondary Asthma control questionnaire score The ACQ consists of seven questions: five questions are on asthma related symptoms, one on medication use and one on the FEV1. Participants are asked to score their symptoms and medication use of the past week on a scale from zero to six. The score of the ACQ is the average score on the seven questions. A score of zero means that asthma is fully controlled; a score of six means that asthma is severely uncontrolled. The minimal clinically important difference is 0.5. The ACQ has been validated and is widely use in research and clinical settings. T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Forced expiratory volume in 1 second Amount of air that can be exhaled forcefully in one second in Liters or % T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Forced vital capacity Amount of air that can be exhaled forcefully in total in Liters or % T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Asthma related medication use Self-reported medication use Throughout 1 year
Secondary Number of visits to the general practitioner or hospital Self-reported amount of visits to the general practitioner or hospital Throughout 1 year
Secondary Incidence counts of exacerbations and other asthma related complaints Self-reported amount of exacerbations and other asthma related complaints Throughout 1 year
Secondary Duration of exacerbations Self-reported duration of exacerbations Throughout 1 year
Secondary Severity of exacerbations Self-reported severity of exacerbations Throughout 1 year
Secondary Calculated disease load Number x duration of exacerbations Throughout 1 year
Secondary Number of infections that occur throughout the study Self-reported amount of infections Throughout 1 year
Secondary Leukocyte count Number of leukocytes measured in EDTA plasma T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Leukocyte differential count Number of subgroups of leukocytes measured in EDTA plasma T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Red blood cell count Number of red blood cells measured in EDTA plasma T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Platelet count Number of platelets measured in EDTA plasma T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Hematocrit Hematocrit measured in EDTA plasma T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Hemoglobin Hemoglobin measured in EDTA plasma T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Immune parameters (1) Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system T=0 months, T=6 months, T=12 months
Secondary Immune parameters (2) Total IgE T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Immune parameters (3) Total IgM T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Immune parameters (4) hsCRP T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Fasted metabolism (1) Serum lipid and lipoprotein profile T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Fasted metabolism (2) Serum non-cholesterol sterols and stanols T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Fasted metabolism (3) Plasma glucose metabolism T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Vascular function markers (1) Carotid-femoral pulse wave velocity (PWV) T=0 months and T=12 months
Secondary Vascular function markers (2) Pulse wave analysis (PWA) T=0 months and T=12 months
Secondary Vascular function markers (3) Retinal microvascular caliber T=0 months and T=12 months
Secondary Cardiometabolic risk marker Office blood pressure T=0 months and T=12 months
Secondary Cognitive function CANTAB tests T=0 months and T=12 months
Secondary Anthropometry (1) Body weight T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Anthropometry (2) Height T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Anthropometry (3) Body mass index T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Anthropometry (4) Waist circumference T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Anthropometry (5) Hip circumference T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Anthropometry (6) Waist-to-hip ratio T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Quality of life score 32-item questionnaire (including social, spiritual, emotional, cognitive, physical, activities of daily living, and integrated Quality of Life) T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Fatigue Fatigue severity score (FSS), a 9-item questionnaire is used to determine the severity of fatigue a subject experienced in the past week during daily activities T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Physical activity Baecke's questionnaire T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Mood Affect grid T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Secondary Diet Food frequency questionnaire is used to determine if the participants maintain their habitual diet and to determine if the participants do not consume plant stanols and/or sterols outside the intervention T=0 months, T=6 months, T=12 months
Secondary Immune cell characterisation Fluorescence-activated cell sorting (FACS) T=0 months, T=6 months, T=12 months
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