Does eating artisanal bread affect metabolism, inflammation or gut flora in people with metabolic syndrome?

Not Applicable

• Conditions: Metabolic syndrome; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN10891611
• Lead Sponsor: The Carlos III Health Institute (Instituto De Salud Carlos III) (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-04
• Last Update Posted: 29 July 2019
• Study Completion: 2020-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Aged 30-75 years
2. Meets metabolic syndrome criteria, with at least 3 of the following:
2.1. Triglycerides =50 mg/dl or taking medication for hypertriglyceridemia (e.g. fibrates)
2.2. Glycemia =100 mg/dl or taking medication to reduce it
2.3. High blood pressure, i.e. =130/85 mmHg or taking antihypertensive medication
2.4. HDL cholesterol <40 mg/dL in men or <50 mg/dL in women or taking medication for treatment (e.g. nicotinic acid/niacin)
2.5. Waist circumference =102 cm in men or =88 cm in women

Exclusion Criteria

1. Use of antibiotics, prebiotics or probiotics 3 months before starting the study
2. Diagnosis of celiac disease
3. Diagnosis of inflammatory bowel disease (IBD)
4. History of intestinal resection
5. Any serious active disease that might prevent the participant adequately following the study
6. Alcoholism or active drug addiction
7. Use that cannot be stopped for the study of non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressant agents, antibiotics and proton pump inhibitors
8. Inability to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified