Plant Stanol Esters and Preventing Asthma Symptoms

Cardiovascular Diseases Clinical Trial

— PLANTASTIC  

Official title:

Plant Stanol Esters in the Prevention of Clinical Symptoms Related to Asthma: The PLANTASTIC Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03983603
• Other study ID #: METC 18-064
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Asthma
• Asthma, Allergic
• Cardiovascular Diseases

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