None listed
Conditions
Brief summary
This randomised control trial (RCT) will examine how an increase in the consumption of dietary fibre, in the form of BarleyMax, affects body composition (including weight loss) and health in overweight and obese individuals. This study will be conducted at QUT and recruit 150 males and females aged 18-50 years old, who will be randomly assigned to one of three conditions at study entry: (1) Receive daily servings of 32 grams of additional fibre for 12 weeks. (BARLEYsupermax condition); (2) Receive daily servings of 16 grams of additional fibre for 12 weeks (BARLEYmax) or (3) Receive 16 grams of placebo product (control). The primary outcome measure for this project is body composition changes (body weight, fat mass, fat distribution, Body Mass Index (BMI), waist to hip ratio (WHR), Blood pressure (BP) and waist circumference). Secondary outcome measures will include biological factors including the gut microbiome, blood analytes relevant to health outcomes, quality of life, appetite, satiety, gastrointestinal discomfort and assessment of facilitators and barriers to completing the intervention programme and its acceptability. All outcome measurements besides those taken from interviews will be performed at baseline, then repeated at the end of the 12 weeks intervention. This RCT aims to examine how an increase in dietary fibre (in the form of BarleyMax) in an ad libitum diet affects body composition (including weight loss) and blood indicators relevant to chronic disease outcomes in obese and overweight individuals. Two recent systematic reviews and meta-analysis both argue that more research is required to examine the efficacy of increased fibre on body composition with studies required of longer duration (> 8 weeks) and higher daily doses (> 30 grams day) (Reynolds et al., 2019; Jovanovski et al., 2020).
Interventions
Participants will be randomly assigned to one of three conditions at study entry: (1) Receive daily servings of 32 grams of additional fibre for 12 weeks. (BARLEYsupermax condition); (2) Receive daily servings of 16 grams of additional fibre for 12 weeks (BARLEYmax) or (3) Placebo. Servings will be in the form of flakes and will be added into meals i.e. breakfast cereal, desert.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 and 50 years of age; 2. Male or female; 3. Have a body mass index between 24.9 - 34.9 Kg.m-2.
Exclusion criteria
1. Have a history or presence of a comorbid disease for which diet modifications may be contraindicated (e.g., gastrointestinal diseases such as ulcerative colitis, Crohn’s disease and other inflammatory bowel diseases, irritable bowel syndrome, celiac disease, diverticulitis, polycystic ovary syndrome, hypoproteinemia). 2. Have a history of eating disorders. 3. Have a history of bariatric surgery. 4. Have a nut allergy. 5. Currently taking, or have taken in the last 3 months, dietary supplements for thyroid, hyperlipidemia, hypoglycaemia, or weight loss supplements (e.g., ephedra, thermogenic compounds). 6. Have participated in a diet or clinical trial in the last 6 months. 7. Females only: women with menopausal symptoms, women who are currently pregnant or are currently breastfeeding. 8. Mental or cognitive impairment that limits the ability to understand test instructions.
Outcome results
None listed