None listed
Conditions
Brief summary
We propose a novel hypothesis that short-chain fatty acids (SCFAs) influence BP through the ‘gut-brain axis’. The two key systems involved in this process are the 'fight or flight' (sympathetic nervous system, SNS) and the 'rest and digest' (parasympathetic nervous system, PNS), both part of the autonomic nervous system (ANS). Our primary aim is to quantify if SCFAs modulate SNS and PNS activity associated with BP regulation. Understanding the influence of SCFAs on the gut-brain axis could pave the way for new treatments for hypertension and other conditions linked to this axis, such as irritable bowel syndrome and neuropsychiatric disorders like depression and anxiety. This research could lead to advances in managing these debilitating conditions.
Interventions
The substance being given to the participants in this study is HAMSA/B, an amylose starch that has been acetylated and butyrylated. Participants will be given 40g/day in two serves (20g/serve) in the morning and night along side their usual breakfast and dinner for 14 days. We have commissioned Premium Blends, a company that develops shake powder (such as protein powder), that will develop and sachet the supplement into individual serves, as well as placebo sachets with the same taste and mass.
The substance being given to the participants in this study is HAMSA/B, an amylose starch that has been acetylated and butyrylated. Participants will be given 40g/day in two serves (20g/serve) in the morning and night along side their usual breakfast and dinner for 14 days. We have commissioned Premium Blends, a company that develops shake powder (such as protein powder), that will develop and sachet the supplement into individual serves, as well as placebo sachets with the same taste and mass. At the beginning of each intervention period, participants will be given their supplement sachets by the study coordinator at the scheduled visits. The participants will empty the contents of one sachet into the provided shaker, fill with their desired amount of water, and shake to mix, The first intervention period of 14 days, is followed by a 20 day wash out period, and then the next intervention period of a further 14 days. To monitor adherence to the intervention, we will require the participants to complete a 3-day food diary using the app 'Easy Diet Diary', as well as the return of any unused sachets.
Sponsors
Professor Francine Marques - Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1) BMI 18.5-35 kg/m2; 2) BP categorised as hypertension (systolic BP of 140 mmHg and/or diastolic BP of 90 mmHg), defined according to the Australian Heart Foundation guidelines; 3) Intake of whole grains lower than 2 servings per day (females) and 3 servings per day (males);
Exclusion criteria
1) Use of anti-hypertensive medication (current or in the past 4 weeks); 2) Office systolic BP greater than 160 and/or diastolic BP greater than 100 mmHg; 3) Recent use of oral antibiotics (for the past 3 months); 4) Recent use of probiotics (for the 4 weeks); 5) Current use of laxatives; 6) Presence of type 1 or type 2 diabetes; 7) Pregnancy or plans to conceive during the course of the trial; 8) Presence of gastrointestinal diseases (including inflammatory bowel disease, lactose intolerance, celiac disease, chronic constipation, chronic pancreatitis or other malabsorption disorder) and/or diagnosed mental health disorders (anxiety and depression); 9) Compromised immune system, regular use of steroid treatment, or use of GLP-1 agonists;
Outcome results
None listed