Plant Stanol Esters and Preventing Asthma Symptoms (PLANTASTIC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Asthma, Allergic
• Intervention / Treatment: Dietary supplement: Soft chews containing 0.5g plant stanols (delivered as plant stanol esters); Dietary supplement: Placebo soft chew

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229ER
      • Recruiting
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Plant stanol group; This arm receives soft chews containing 0.5g of plant stanols (delivered as plant stanol esters).	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_COMPARATOR: Placebo group; This arm receives soft chews that do not contain 0.5g of plant stanols (delivered as plant stanol esters).	Dietary supplement: Placebo soft chew; Soft chew that does not contain plant stanols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Asthma related medication use	Self-reported medication use	Throughout 1 year
Number of visits to the general practitioner or hospital	Self-reported amount of visits to the general practitioner or hospital	Throughout 1 year
Incidence counts of exacerbations and other asthma related complaints	Self-reported amount of exacerbations and other asthma related complaints	Throughout 1 year
Duration of exacerbations	Self-reported duration of exacerbations	Throughout 1 year
Severity of exacerbations	Self-reported severity of exacerbations	Throughout 1 year
Calculated disease load	Number x duration of exacerbations	Throughout 1 year
Number of infections that occur throughout the study	Self-reported amount of infections	Throughout 1 year
Leukocyte count	Number of leukocytes measured in EDTA plasma	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
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
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
Platelet count	Number of platelets measured in EDTA plasma	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Hematocrit	Hematocrit measured in EDTA plasma	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Hemoglobin	Hemoglobin measured in EDTA plasma	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
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
Immune parameters (2)	Total IgE	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Immune parameters (3)	Total IgM	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Immune parameters (4)	hsCRP	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Fasted metabolism (1)	Serum lipid and lipoprotein profile	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Fasted metabolism (2)	Serum non-cholesterol sterols and stanols	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Fasted metabolism (3)	Plasma glucose metabolism	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Vascular function markers (1)	Carotid-femoral pulse wave velocity (PWV)	T=0 months and T=12 months
Vascular function markers (2)	Pulse wave analysis (PWA)	T=0 months and T=12 months
Vascular function markers (3)	Retinal microvascular caliber	T=0 months and T=12 months
Cardiometabolic risk marker	Office blood pressure	T=0 months and T=12 months
Cognitive function	CANTAB tests	T=0 months and T=12 months
Anthropometry (1)	Body weight	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Anthropometry (2)	Height	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Anthropometry (3)	Body mass index	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Anthropometry (4)	Waist circumference	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Anthropometry (5)	Hip circumference	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Anthropometry (6)	Waist-to-hip ratio	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
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
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
Physical activity	Baecke's questionnaire	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
Mood	Affect grid	T=0 months, T=3 months, T=6 months, T=9 months, T=12 months
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
Immune cell characterisation	Fluorescence-activated cell sorting (FACS)	T=0 months, T=6 months, T=12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Raisio Group; TKI Life Sciences and Health (LSH)

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 29, 2019
• Primary Completion (ANTICIPATED): September 1, 2024
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (ACTUAL): June 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Asthma; Metabolic health; Immune system; Plant stanols
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Cardiovascular Diseases; Asthma
• Other Study ID Numbers: METC 18-064

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No