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Probiotics and health in non-pregnant women: GetGutsy Study

Probiotics and health in non-pregnant women: GetGutsy randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11295995
Enrollment
80
Registered
2018-05-15
Start date
2018-05-21
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Nutritional, Metabolic, Endocrine Obesity

Interventions

Current interventions as of 14/05/2019: Women will be recruited from the Greater Dublin area. They will self identify to the research team in response to flyers, recruitment stalls, social media alert
or the control group who will consume a placebo capsule daily for 12 weeks. The study statistician, who will not be involved in data collection, will produce computer-generated sets of random allocati

Sponsors

University College Dublin
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 14/05/2019: 1. Non-pregnant women aged between 18 to 65 years capable of giving informed consent 2. BMI = 30Kg/m^2 3. Waist circumference > 80cm OR waist:hip ratio = 0.85 4. Raised fasting triglyceride levels Previous participant inclusion criteria: 1. Non-pregnant women aged between 18 to 45 years capable of giving informed consent 2. BMI = 30Kg/m^2 3. Waist circumference > 80cm OR waist:hip ratio = 0.85 4. Raised fasting triglyceride levels

Exclusion criteria

Exclusion criteria: Current participant exclusion criteria as of 14/05/2019: 1. Pregnant or planning to become pregnant in the following 6 months 2. Age 65 years 3. Inadequate level of English to provide informed consent or communicate with the researchers 4. Having a condition or taking a medication, dietary supplement or food product that the investigator believes would interfere with the objectives of the study 5. Actively involved in a weight-loss programme Previous participant exclusion criteria: 1. Pregnant or planning to become pregnant in the following 6 months 2. Age 45 years 3. Inadequate level of English to provide informed consent or communicate with the researchers 4. Having a condition or taking a medication, dietary supplement or food product that the investigator believes would interfere with the objectives of the study 5. Actively involved in a weight-loss programme

Design outcomes

Primary

MeasureTime frame
Level of C-reactive protein, measured by laboratory analysis at baseline and at 12 weeks

Secondary

MeasureTime frame
Collected at baseline and at 12 weeks: 1. Body weight and body fat change, determined by changes in BMI, waist circumference, waist:hip ratio. 2. Inflammation, investigated by measuring changes in inflammatory markers including TNF-alpha 3. Insulin resistance, determined using HOMA index and HbA1c 4. Lipids, assessed by analysis of circulating lipids

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026