Can taking probiotics ('friendly' bacteria) improve metabolic health and wellbeing in people who are overweight or obese?

Not Applicable

Completed

• Conditions: Effects of probiotic supplementation on healthy overweight and obese individuals; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN12562026
• Lead Sponsor: Cultech Ltd

Brief Summary

2020 Results article in https://doi.org/10.1038/s41598-020-60991-7 results (added 05/06/2020) 2021 Results article in https://doi.org/10.1080/19490976.2021.1900997 Further analysis (added 19/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-07-23
• Study Start: 2019-03-12
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Aged between 30 and 65 years at stage 1
2. Waist circumference >89 cm (women) or >100 cm (men) at stage 1
3. Body mass index (BMI) between 25 and 34.9 kg/m2 at stage 1
4. Willing to provide blood samples at stage 1 and stage 3
5. No statin treatment or on stabilised statin therapy (at least 3 months intake before stage 1)

Exclusion Criteria

1. Immunodeficiency or ongoing immunosuppressive therapy
2. Diagnosed diabetes
3. Pregnant or planning pregnancy
4. Anamnesis of ischemic heart disease, heart failure, prolonged QTc interval, rhythm and conduction disorders, e.g. absolute arrhythmia, ventricular extrasystole, atrioventricular block or any other cardiovascular disease deemed by the investigator as a risk for the participation in the study
5. Severe systemic disease (cancer, dementia, advanced organ failure)
6. Weight loss in the last 3 months prior to stage 1, which cannot be explained with a dietary regimen or increased physical activity

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Plasma total cholesterol at baseline (day 0) and day 180<br>2. Plasma HDL-cholesterol at baseline (day 0) and day 180<br>3. Plasma LDL-cholesterol at baseline (day 0) and day 180<br>4. Plasma triacylglycerol at baseline (day 0) and day 180<br>5. Body weight measured on scales at days 0, 90 and 180<br>6. Waist circumference measured by tape at baseline (day 0) and day 180<br>7. Blood pressure measured by a blood pressure monitor at days 0, 90 and 180<br>The methods of analysis for the blood and faecal tests have yet to be finalised.

Secondary Outcome Measures

Name	Time	Method
1. General well-being assessed using a quality of life questionnaire at days 0, 90 and 180<br>2. Gastrointestinal symptoms, such as diarrhoea, constipation, abdominal pain, vomiting, bloating, nausea and infection, recorded daily throughout the intervention period using a daily symptom questionnaire <br>3. Microbiota composition/functionality assessed using next-generation sequencing (NGS) and/or microbial culture at days 0 and 180<br>4. Plasma inflammatory markers (C-reactive protein [CRP]) at days 0 and 180 <br>5. Faecal and plasma bile concentration (total, conjugated and deconjugated) at days 0 and 180<br>The methods of analysis for the blood and faecal tests have yet to be finalised.