Effects of a containing ora-pro-nobis product on the gut and anthropometric data in adults

Not Applicable

• Conditions: Obesity; Women; C18.654.726.500; M01.975

• Registration Number: RBR-3r3mqw
• Lead Sponsor: niversidade Federal de Alfenas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Women, aged between 20 and 60 years. Fat percentage above 25%. Not having participated in weight loss program in the last six months; Be healthy.

Exclusion Criteria

Have a diagnosis of autoimmune, endocrine, cardiac, cerebrovascular, renal, hepatic, gout, gastrointestinal, inflammatory and / or infectious diseases;
have made use of dietary supplements, laxatives and antibiotics in the last six months;
have undergone surgery in the last six months;
have made regular use of alcohol, cigarettes and other drugs in the last year;
be vegetarian;
being on herbal remedies or preparations;
exhibit allergic reactions to product components;
be pregnant or nursing;
have ingested probiotic in the last year.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected Outcome 1 - Body weight reduction, measured by anthropometric assessment, using a portable digital electronic platform scale, made at 1 week before the intervention and 6 weeks after the intervention.;Outcome found 1 - Body weight reduction by - 0.76 Kg, measured by anthropometric assessment, using a portable digital electronic platform scale, made at 1 week before the intervention and 6 weeks after the intervention.

Secondary Outcome Measures

Name	Time	Method
Expected Outcome 2 - Waist circumference reduction, measured by means of an anthropometric evaluation, using a tape measure, done 1 week before the intervention and 6 weeks after the intervention.;Outcome found 2 - Waist circumference reduction by - 0.83 cm, measured by means of an anthropometric evaluation, using a tape measure, done 1 week before the intervention and 6 weeks after the intervention.;Expected Outcome 3 - Reduction of gastrointestinal symptoms, assessed using the gastrointestinal symptom rating scale questionnaire of at least 1 point of the total score, made first week pre and post intervention.;Outcome found 3 - Improvement in the score of some gastrointestinal symptoms, such as increased satiety, reduced eructation, reduced constipation, improved stool consistency, and reduced incomplete bowel sensation assessed through the gastrointestinal symptom rating scale questionnaire made in the first week before and after the intervention.