A 12 month randomised controlled trial to determine biomarkers from the gut microbiota as management tools for overweight and obesity

Not Applicable

Completed

• Conditions: Overweight and obesity; Diet and Nutrition - Obesity

• Registration Number: ACTRN12612000603819
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To develop rapid methods based on microbial biomarkers by which clinicians can predict:<br>(i) Those who will achieve weight loss in any given lifestyle program and;<br>(ii) Those who will be maintain their weight loss.[Baseline, Month 1, Month 3, Month 6, and Month 12.<br>Subjects will provide stool samples at these clinic visits for molecular biology processing (PCR, flow cytometry and DGGE) and sequencing.]

Secondary Outcome Measures

Name	Time	Method
1. To test the hypothesis that homeostatic control of the microbiota constrains weight loss outcomes in lifestyle programs.[Baseline, Month 1, Month 3, Month 6, Month 12. <br>Subjects will provide stool samples at these clinic visits for molecular biology processing (PCR, flow cytometry and DGGE) and sequencing.];2. To examine the differences in weight loss between groups.[Month 6, Month 12.<br>Subjects will be weighed at clinic visits.];3. To investigate changes in a number of indicators of metabolic disease between groups - fasting blood glucose, lipid profile, liver function, and inflammatory markers.[Month 6, Month 12.<br>Fasting bloods will be taken at clinic visits.];4. To investigate the change in appetite hormones with changes in microbiota.[Month 3, Month 6, Month 12.<br>Fasting bloods will be taken at clinic visits.]