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

NCT04962633 | Completed

• 1 other identifier: ProPas
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Changes in fasting inflammatory blood markers

  Measure of plasma C-reactive protein (mmol/L)

  1 months

• Changes in fasting plasma lipids

  Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides

  1 months

• Changes in fasting plasma glucose

  Measure of plasma glucose concentrations (mg/dL)

  1 months

Secondary Outcomes (25)

• Changes in small intestine permeability

  1 month

• Changes in colonic permeability

  1 month

• Changes in stool consistency

  1 month

• Changes in stool weight

  1 month

• Changes in stool frequency

  1 month

Study Arms (2)

Probiotic Pasta Group

EXPERIMENTAL

Subjects in the Probiotic Pasta group will consume 80 g per day of a probiotic pasta for 4 weeks

Other: Probiotic Pasta

Control Pasta Group

ACTIVE COMPARATOR

Control Pasta Subjects in the Control Pasta group will consume 80 g per day of conventional pasta for 4 weeks.

Other: Control Pasta

Interventions

Probiotic Pasta OTHER

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.

Probiotic Pasta Group

Control Pasta OTHER

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.

Control Pasta Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy subjects;
• men and women;
• age 18-65 years;
• kg/m2 ≤ BMI ≤ 35 kg/m2;
• habitual daily pasta consumption (≥ 1 portion/day);
• habitual diet characterized by absence of any food supplements and alternative medication, probiotics and prebiotics, whole grain and/or fiber enriched foods;
• intake of fruit/vegetables \< 3 servings/day;
• low level of physical activity (\< 500 metabolic equivalent min/week);
• signed written informed consent.

You may not qualify if:

• food allergies and intolerances and celiac disease;
• gastrointestinal diseases;
• relevant diseases;
• pregnant or breastfeeding;
• previous abdominal surgery;
• hypertriglyceridemia (Triglycerides \> 200 mg/dL);
• hypercholesterolemia (Total cholesterol \> 200 mg/dL);
• hyperglycaemia (glycaemia ≥ 110 mg/dL);
• hypertension (arterial blood pressure ≥140/90 mm Hg);
• weight loss ≥ 3 kg within 2 months before the study;
• antibiotics treatment within 3 months before the study;
• any medication (different from antibiotics) at the enrollment and within 2 months before the study;
• habitual diet characterized by high fruit and vegetables intakes (\>3 portion/die);
• high level of physical activity;
• Alcohol consumption ≥ 3 alcohol units per day;

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Agricultural Sciences

Portici, 80055, Italy

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paola Vitaglione, Professor

  Department of Agricultural Sciences, Federico II University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: July 15, 2021
• Study Start: January 1, 2022
• Primary Completion: December 23, 2022
• Study Completion: December 31, 2022
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

IT (1)