None listed
Conditions
Brief summary
The aims of this study are to determine whether a 4-week, daily supplementation of a New Zealand berry fruit supplement product (BerriQi®) can improve lung function in free-living adults with pulmonary sarcoidosis over baseline (day 0) values. We hypothesise that BerriQi® consumption can improve breathing parameters as measured by spirometry and also result in improved serum ACE and blood liver function tests. This is a randomised crossover placebo-controlled double blind study.
Interventions
The study duration is 12 weeks; 2-week lead-in period for screening, recruitment, and baseline measurements, followed by a 4-week intervention period, a 2-week washout period, followed by another 4-week intervention period.
Participants will be recruited from sarcoidosis support e-groups. The aims of the study and investigational product will be described, along with descriptions of the questionnaires and the medical data sought, and information for their healthcare providers. It is expected th
The study duration is 12 weeks; 2-week lead-in period for screening, recruitment, and baseline measurements, followed by a 4-week intervention period, a 2-week washout period, followed by another 4-week intervention period. Participants will be recruited from sarcoidosis support e-groups. The aims of the study and investigational product will be described, along with descriptions of the questionnaires and the medical data sought, and information for their healthcare providers. It is expected that motivated support e-group members will volunteer to participate. Following emailed confirmation of participation, receipt of written informed consent and appropriateness of volunteered data, participants will be courier-posted to consume daily, for 4 weeks, either a 30 mL berry fruit beverage (BerriQi®) or a heat-inactivated version (placebo) and asked to continue to volunteer appropriate medical data from their usual medical monitoring regime. Participants will continue with their usual ongoing medical treatment. After 4 weeks, participants will have a 2 week washout period, followed by another 4-week intervention period where they will be sent to consume daily , either a 30 mL berry fruit beverage (BerriQi®) or a heat-inactivated version (placebo) and continue to volunteer medical data. At baseline (Day 0), midpoint (Day 14) and endpoint (Day 28) of each intervention, participants will complete questionnaires to assess their dietary habits as a means of ensuring compliance and to remind them to avoid berry-based foods, and at the beginning (Day 0) and end (Day 28) of each intervention to assess their lung health. Participants will provide lung function and liver function tests, obtained from their healthcare provider at the beginning (Day 0) and end (Day 28) of each intervention as a part of the routine monitoring of their condition. These results will be sent by email. This study will be conducted entirely online with investigational product and placebo sent by mail. Used and unused bottles will be returned by mail to check compliance.
Sponsors
Anagenix Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
a. They are an adult aged 18-65 b. They have had biopsy-proven pulmonary sarcoidosis for at least one year c. They are on stable medication (e.g. prednisone, other, or none) dose for at least 4 weeks prior to recruitment, and unlikely to change medication during the course of this study d. They are not currently participating in another clinical interventional study e. They will provide written informed consent f. They agree to avoid eating other berry fruits or foods likely to contain berry fruit for the duration of the study.
Exclusion criteria
a. Current or prior (previous four weeks) respiratory tract infection b. Current or prior eating disorder (e.g. anorexia nervosa, bulimia) that would interfere with consumption and/or absorption of the investigational product c. Food allergy or intolerance that would compromise compliance with the study protocol, including berry fruits and apples
Outcome results
None listed