None listed
Conditions
Brief summary
It was hypothesised that combining lifestyle modification with dietary fibre supplementation will be more effective for weight loss than either strategy alone. The aim was to examine the effect of a specific lifestyle modification program (LSMA, AstonRx Program) combining time-restricted eating (TRE) and dietary fibre supplementation on body weight, body composition and biomarkers of metabolic health in healthy overweight adults. Using a randomized, double-blind, placebo-controlled trial, the study aimed to examine the effect of a specific lifestyle modification program (LSMA, AstonRx Program) combining time-restricted eating (TRE) and dietary fibre supplementation on body weight, body composition and biomarkers of metabolic health, and safety and tolerability of a new dietary fibre BioPB-01 in healthy overweight adults. The primary outcomes included – changes in body weight and composition and safety and tolerability of BioPB-01 dietary fibre. The secondary outcomes included - changes in lipid profiles, fasting blood glucose and insulin levels, gut microbiota structure and function and inflammatory markers.
Interventions
Allocation: Randomised
Intervention Model: Parallel assignment
Intervention Model Description: Randomised, double-blind, controlled study with unblinded lifestyle modification advice, parallel assignment
Participants were randomly assigned into one of four groups (A-D):
A, the Control group that received a placebo (rice powder);
B, which received a novel dietary fibre (BioPB);
C, which received lifestyle modification advice (LSMA, AstonRx Program) plus psyllium;
D, received the LSMA plus Bi
Allocation: Randomised Intervention Model: Parallel assignment Intervention Model Description: Randomised, double-blind, controlled study with unblinded lifestyle modification advice, parallel assignment Participants were randomly assigned into one of four groups (A-D): A, the Control group that received a placebo (rice powder); B, which received a novel dietary fibre (BioPB); C, which received lifestyle modification advice (LSMA, AstonRx Program) plus psyllium; D, received the LSMA plus BioPB. Intervention details: The intervention period was four weeks. During the intervention period, participants consumed either 4.2 g of BioPB, psyllium, or placebo twice daily, sprinkled over meals. BioPB comprised equal proportions of Carrageenan, Konjac and cellulose (hence about 60% soluble fibre and 40% insoluble fibre). After the cessation of the intervention period, participants were followed up for an additional four weeks. Seventy -seven subjects were randomly assigned to four groups and 67 completed the study. LSMA (AstonRx Program): A 28-day customised online lifestyle modification program that provides participants access to an Interactive dashboard that delivers education, and a detailed daily meal plan with portion sizes (incorporating diverse fibrous plant foods) based on an individual’s lean body weight. It also instructs participants to follow time-restricted eating (TRE - circadian) and avoid consuming alcohol, sugar, refined CHO or artificial sweeteners. The program commences with 3 meals a day, with a minimum 5-hour fast between meals and a minimum 12-hour overnight fast. Participants are encouraged to finish eating during daylight hours and at least 3-4 hours before sleep. From Day 10 onwards, participants have increased metabolic flexibility and may opt for 2 meals a day on any day they wish.
Sponsors
Australian Government Department for Industry, Innovation and Science
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Age: 19 -65 years Gender: Both male and female BMI: 25 - 29.9 kg/m2 Able and willing to provide written consent to enroll in the study and comply with the study guidelines Willingness to provide dietary records (days 0, 28 and 56), and blood and stool samples (self-collected) on days 0, 28 and 56 of the study Willingness to maintain and provide information on bowel movement frequency, stool consistency and GI symptoms at weekly intervals during the intervention period.
Exclusion criteria
Unable or unwilling to give informed consent; Do not meet the BMI criteria History of diverticulitis; allergy or intolerance to the treatment dietary fibre; use of glucose-lowering medications (e.g. diabetes medications) or use of medications known to influence body weight (e.g. GLP-1 receptor agonists, certain antidepressants), lipid metabolism (e.g. cholesterol medications) or gut function; use of proton pump inhibitors (e.g. esomeprazole used in the treatment of gastroesophageal reflux disease); history of gastrointestinal surgical interventions; coeliac disease; clinically diagnosed irritable bowel syndrome (IBS); diseases of the gallbladder; eating disorders; pregnant, planning to be pregnant or breastfeeding at any point during the study; regular intake of laxatives in the past month and during the study; a history of eating disorders; documented chronic diseases including Type 1 diabetes, hyperthyroidism, cancer, liver or renal failure; currently enrolled in another study; anaemic and difficulty with blood draws; or presence of psychiatric disorders. Additional exclusion criteria include weight unstable in the previous 3 months (evident by a loss or gain of more than 10% of total body weight), taking other contraindicated medication (i.e., antibiotics, psychotropic drugs or appetite suppressants), or use of any dietary supplement that might interfere with the results of the study.
Outcome results
None listed