ANTIC Study: A Nutrition Trial in Chronic obstructive pulmonary disease (COPD)
A phase 2, prospective, randomised, open, blinded end-point (PROBE), controlled, cross-over, multi-centre, assessing the effect of a nutritional intervention on IL-6 levels in adults aged 40 years and over with chronic obstructive pulmonary disease (COPD)
University of Sydney
120 participants
Jan 13, 2025
Interventional
Conditions
Summary
The aim of the ANTIC study is to identify one or more promising nutrition interventions targeting the gut-lung axis to reduce inflammation in COPD. This will be a 3-way crossover trial, with each intervention period run for 4 weeks, with a 4-week washout between each intervention. Interventions to be tested are: • Inulin, 6 grams twice daily with food • High Amylose Maize Starch, 10 grams twice daily with food • Control period, usual dietary intake.
Eligibility
Inclusion Criteria5
- Adults aged 40 years and over,
- Current or ex-smokers (with smoking history >=10 pack years),
- Have a diagnosis of COPD with a post-bronchodilator ratio of forced expiratory volume (FEV1) to forced vital capacity of less than 0·7,
- On stable COPD-directed medication for 28 days prior to screening,
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
Exclusion Criteria5
- Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids in the 28 days prior to screening,
- Co-morbid lung diseases (lung cancer, interstitial lung disease, bronchiectasis). A diagnosis of asthma is allowed if COPD is the primary condition.
- Habitual fibre intake no more than 40g per day.
- Use of fibre-based supplements in the preceding 28 days prior to enrolment,
- Significant digestive issues, such as inflammatory bowel disease, hereditary fructose intolerance.
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Interventions
ANTIC is a 3-way crossover trial, with each intervention period run for 4 weeks, with a 4-week washout between each intervention. Interventions to be tested are: • Inulin, 6 grams of powder to be taken twice daily with food (mixed into usual meals) or liquid • High Amylose Maize Starch, 10 grams of powder taken twice daily with food (mixed into usual meals) or liquid • Control period, usual dietary intake. Patients will record intake in a patient diary. At the end of each intervention, the powder will be returned.
Locations(1)
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ACTRN12624001433594