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Dietary Intervention With Probiotic Pasta and Evaluation of the Effects on Metabolic and Inflammatory Status

NCT04962633 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-02-17

No results posted yet for this study

Summary

This study aims to investigate the effects of daily consumption for 4 weeks of a probiotic durum wheat pasta vs a conventional durum wheat pasta without probiotics on fasting metabolic parameters and inflammatory status, on gut permeability and functionality, on daily energy intakes, appetite feelings, body weight, body mass index (BMI), waist and hip circumferences, blood pressure, body composition and wellbeing status in overweight and obese subjects.

Conditions

  • Overweight and Obesity

Interventions

OTHER

Probiotic Pasta

Subjects will consume for 4 weeks 80 g per day of probiotic durum wheat pasta. All subjects will be requested not to change the other daily dietary habits and their physical activity levels during the 4 week intervention period.

OTHER

Control Pasta

Subjects will consume for 4 weeks 80 g per day of conventional durum wheat pasta without probiotics. All subjects will be requested not to change the other daily dietary habits and their physical activity levels during the 4 week intervention period.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Paola Vitaglione, Professor · Department of Agricultural Sciences, Federico II University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-12-23
Completion
2022-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04962633 on ClinicalTrials.gov