None listed
Conditions
Brief summary
Microbes influence how much energy we extract from our diet, how we regulate the storage of this as fat, and also on glucose regulation. There are both good and bad microbes. We have found that in overweight or obese persons undergoing weight loss diets not everyone is successful and significantly those who fail to lose weight are also those who fail to change their microbial community composition. In this study we aim to identify microbial signals in stool samples that will allow clinicians to predict which diets will give successful weight loss outcomes (thus avoiding the frustration of diet failures) and also to test how to improve and change a person’s microbiota to a healthy composition.
Interventions
Subjects are randomised to either a standardised high protein, Mediterranean, or low fat (low GI) diet. Subjects will meet the study dietitian for advice on their allocated diet and prescribed the diet for weight loss i.e. based on the Harris Benedict Equation for estimating energy requirements with an energy deficit of 500 calories daily. Each of the diets will be followed daily over a six month period. Subjects will then be followed up for a further six months (up to month 12). Each of the die
Subjects are randomised to either a standardised high protein, Mediterranean, or low fat (low GI) diet. Subjects will meet the study dietitian for advice on their allocated diet and prescribed the diet for weight loss i.e. based on the Harris Benedict Equation for estimating energy requirements with an energy deficit of 500 calories daily. Each of the diets will be followed daily over a six month period. Subjects will then be followed up for a further six months (up to month 12). Each of the diets will be costed relatively the same so that there is no extra cost for the participant depending on their randomisation group. For those randomised to the high protein diet, strategies for cutting cost will be educated to participants at the baseline and follow up visits. For example, recipes for budget cuts of meat will be provided, as well as focusing their diets on cheaper sources of protein including canned fish, eggs, milk and yoghurt. Home brand alternatives of similar nutritional quality with also be encouraged. This will also be applicable to those in the Mediterranean diet when including fish and olive oil products. The low GI diet will be based on foods endorsed by the glycemic index foundation with the latest GI values for popular foods explained to subjects.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Aged 18 years or older BMI 25 – 35 kg/m2
Exclusion criteria
Recent diagnosis of diabetes (< 3 months) Unstable angina or recent onset of cardiovascular disease Serious hepatic or renal disease - serum transaminases (ALT or AST) > 2.5 times upper limit of normal - serum creatinine > 1.5 times upper limit of normal or urinary microalbumin >40 mg/L or eGFR < 60ml/min/1.73m2 Alcohol or illicit drug abuse Pregnant, breastfeeding, or planning pregnancy during the study Treatment for an eating disorder, weight loss medications and other drugs that affect body weight e.g. anti-psychotics, anti-depressants, or corticosteroids Hypothyroidism defined by elevated thyroid stimulating hormone (TSH) and low free thyroxine (fT4), or current hyperthyroidism under treatment Participation in another weight loss clinical trial within past 3 months Individuals who have lost >10% weight within past 3 months Inability to read and write English Subjects who frequently change smoking habits or who have stopped smoking within 6 months prior to screening. Those who wish to take on the advice of a 'Quit' smoking program at the time of screening will be eligible to start the trial after 3 months. Subjects not willing to participate in all of the specimen collection. Individuals with known penicillin and/or cephalosporin hypersensitivity will not be eligible for randomisation to the antibiotic treatment, however will still be eligible for entry into the trial
Outcome results
None listed