Microbiome-Tailored Food Products Based On Typical Mediterranean Diet Components

NCT05451992 | Completed DMC

• 1 other identifier: SuperFood 01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The composition and functions of the microbiome impact human metabolism and health status. Diet plays a fundamental role in shaping the structure of the gut microbiome, modulating the interaction between the gut microbiome and the human host. Western dietary patterns including a high consumption of red and processed meat, refined grains and sugars, and dairy products have been associated with a high incidence of chronic diseases. It is widely recognised that there is a higher consumption of plant-based foods in Mediterranean countries than in other Western countries. The Mediterranean diet involves a high intake of fruits, vegetables, legumes, nuts, minimally processed cereals, moderate consumption of fish and a low consumption of saturated fats, meat and dairy products with regular intake of extra virgin olive oil. The Mediterranean diet reduces the incidence of cardiovascular, metabolic and neurodegenerative diseases. Interesting results emerged from the evaluation of the microbiome-metabolome interaction, which shows that individuals with the highest adherence to the Mediterranean diet had much higher levels of short-chain fatty acids (SCFAs) and increased levels of the beneficial fiber-degrading bacteria compared to subjects with low adherence to the Mediterranean diet. The study of the effect on the microbiota of specific foods with anti-inflammatory/antioxidant properties is interesting and of potential clinical impact.

Conditions

Microbiota; Overweight and Obesity; Metabolic Complication

Keywords

Microbiota; Mediterranean diet; Overweight; Metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Effects of SuperFood on gut Microbiota and metabolome

  Analysis of the gut microbiome by DNA extraction from faecal samples and high-throughput rRNA gene-targeted amplicon sequencing Gut metabolome: Faecal samples will be analysed by GC-MS and 1H-NMR. Faecal phenolic compounds and their derivatives as well as endocannabinoids will be also analysed. The amount of faecal SCFA before/after dietary intervention will be used as markers for selecting individuals for further meta-proteomic analysis

  2 months

Secondary Outcomes (3)

• Effects of SuperFood on Body Mass Index

  2 months

• Effects od SuperFood on serum gluco-lipid profile

  2 months

• Effects of SuperFood on hormones

  2 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Control group that will consume a placebo product

Dietary Supplement: Placebo

SuperFood

EXPERIMENTAL

The superfood group will have to consume the superfood product (vegetable smoothie)

Dietary Supplement: SuperFood

Interventions

Placebo DIETARY_SUPPLEMENT

The group will have to consume a jar every day (approx. 75 ml) which contain (water, malt-dextrins, 0.1% starch, 0.1% guar gum, flavorings and colorants)

Placebo

SuperFood DIETARY_SUPPLEMENT

The group will have to consume a jar of superfood (vegetable smoothie) every day. The jar will be filled with approx. 75 ml which corresponds to about 75 g. The superfood formulated by the University of Bolzano on the basis of the results and evidence acquired in collaboration with the Istituto Superiore di Sanità. Composition: pomegranate, walnuts, moringa, broccoli, according to the proportions indicated in Annex 2. This mixture has been analyzed by an external laboratory and authorized for human use

SuperFood

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects able to sign the Informed Consent
• Age 30-60 years;
• BMI 25-29.9 kg/m2
• Low adherence to the Mediterranean diet (score between 0-5)

You may not qualify if:

• Subjects not able to provide informed consent
• obesity (BMI\> 30 kg /m2), diabetes, dysthyroidism, food allergies, alterations of the alvo, any intestinal disease, liver, kidney, or other organ/apparatus pathologies, regular use of drugs or food supplements, consumption of antibiotics in the 3 months prior to the experiment or need for a specific diet, pregnancy /lactation.
• SARS-CoV-2 infection

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"

Bari, BA, 70124, Italy

Location

Related Publications (6)

• Vacca M, Celano G, Calabrese FM, Portincasa P, Gobbetti M, De Angelis M. The Controversial Role of Human Gut Lachnospiraceae. Microorganisms. 2020 Apr 15;8(4):573. doi: 10.3390/microorganisms8040573.

  PMID: 32326636 BACKGROUND

• De Angelis M, Garruti G, Minervini F, Bonfrate L, Portincasa P, Gobbetti M. The Food-gut Human Axis: The Effects of Diet on Gut Microbiota and Metabolome. Curr Med Chem. 2019;26(19):3567-3583. doi: 10.2174/0929867324666170428103848.

  PMID: 28462705 BACKGROUND

• Vitellio P, Celano G, Bonfrate L, Gobbetti M, Portincasa P, De Angelis M. Effects of Bifidobacterium longum and Lactobacillus rhamnosus on Gut Microbiota in Patients with Lactose Intolerance and Persisting Functional Gastrointestinal Symptoms: A Randomised, Double-Blind, Cross-Over Study. Nutrients. 2019 Apr 19;11(4):886. doi: 10.3390/nu11040886.

  PMID: 31010241 BACKGROUND

• Bonfrate L, Di Palo DM, Celano G, Albert A, Vitellio P, De Angelis M, Gobbetti M, Portincasa P. Effects of Bifidobacterium longum BB536 and Lactobacillus rhamnosus HN001 in IBS patients. Eur J Clin Invest. 2020 Mar;50(3):e13201. doi: 10.1111/eci.13201. Epub 2020 Feb 12.

  PMID: 31960952 BACKGROUND

• Portincasa P, De Angelis M, Lammert F, Stokes CS. Medicinal Diets: From Molecules to Nutrients to Foods: Basic and Clinical Implications. Curr Med Chem. 2019;26(19):3372-3375. doi: 10.2174/092986732619190821150547.

  PMID: 31564245 BACKGROUND

• Portincasa P, Bonfrate L, Vacca M, De Angelis M, Farella I, Lanza E, Khalil M, Wang DQ, Sperandio M, Di Ciaula A. Gut Microbiota and Short Chain Fatty Acids: Implications in Glucose Homeostasis. Int J Mol Sci. 2022 Jan 20;23(3):1105. doi: 10.3390/ijms23031105.

  PMID: 35163038 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

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: Professor, MD

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 11, 2022
• Study Start: February 15, 2021
• Primary Completion: April 15, 2021
• Study Completion: December 15, 2021
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)