Food Supplement for Individuals with Metabolic Syndrome

NCT06647108 | Not Yet Recruiting

• 1 other identifier: MetaTreat_RCT2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In metabolic syndrome, blood levels of apolipoprotein B (Apo B) reveal the presence of quantitative and qualitative alterations of atherogenic lipoproteins and therefore represent an indicator of the risk of developing cardiovascular disease (CVD). The objective of this study is to evaluate the effect of a combined dietary supplement containing glucomannan, white mulberry dry extract (d.e.), gymnema (d.e.), olive (d.e.), Cassia nomame (d.e.), Nopal, policosanols and chromium, compared to placebo, on Apo B in individuals with metabolic syndrome adhering to the Mediterranean diet. Furthermore, the effect of the dietary supplement on anthropometric parameters, waist circumference and body composition will be investigated.

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome; Apolipoprotein B; Dietary Supplement; Food Supplement; Mediterranean Diet; Body Composition

Outcome Measures

Primary Outcomes (1)

• Effect of the Dietary Supplement on Apo B

  The primary objective is to compare the effect on Apo B after 12 weeks of treatment with the dietary supplement or placebo, in combination with the Mediterranean diet (Standard of Care - SOC).

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (9)

• Effect of the Dietary Supplement on changes in body water

  From enrollment to the end of treatment at 12 weeks

• Effect of the Dietary Supplement on changes in lean body mass

  From enrollment to the end of treatment at 12 weeks

• Effect of the Dietary Supplement on changes in fat body mass

  From enrollment to the end of treatment at 12 weeks

• Effect of the Dietary Supplement on changes in waist circumference

  From enrollment to the end of treatment at 12 weeks

• Dietary Supplement use and prevalence of Metabolic Syndrome

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Food Supplement

ACTIVE COMPARATOR

The composition of the dietary supplement is the following (for 1 sachet): 450 mg glucomannan, 250 mg white mulberry dry extract (d.e.), 200 mg gymnema (d.e.), 200 mg olive (d.e.), 200 mg Cassia nomame (d.e.), 200 mg Nopal, 5 mg policosanols and 20 µg chromium.

Dietary Supplement: Food Supplement

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Food Supplement DIETARY_SUPPLEMENT

The composition of the dietary supplement is the following (for 1 sachet): 450 mg glucomannan, 250 mg white mulberry dry extract (d.e.), 200 mg gymnema (d.e.), 200 mg olive (d.e.), 200 mg Cassia nomame (d.e.), 200 mg Nopal, 5 mg policosanols and 20 µg chromium

Food Supplement

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥ 18 years and ≤ 70 years old;
• Subjects with metabolic syndrome (according to the IAS criteria);
• Subjects with an estimated 10-year risk of CVD\< 10% (as per the SCORE risk prediction algorithm of the ESC)
• Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements;
• Subjects agree to participate in the study and having dated and signed the informed consent form

You may not qualify if:

• Treatment with lipid-lowering drugs or taking food supplements that are effective on blood lipid levels;
• Chronic pharmacological treatments for any clinical condition not stabilized for at least 3 months;
• Known alterations in thyroid, renal or hepatic function (including transaminase values ≥ 3 times the times the upper limit of the normal range (ULN));
• Present or previous alcohol abuse;
• Pregnancy and breastfeeding;
• Subjects with known intolerance to one of the components of the tested dietary supplement;
• History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study.

Sponsors & Collaborators

• ESI: lead

Study Sites (1)

IRCCS AOU di Bologna

Bologna, Bologna, 40100, Italy

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Arrigo Francesco Giuseppe Cicero, MD, PhD

  University of Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arrigo Francesco Giuseppe Cicero, MD, PhD

CONTACT

+39 051 214290; arrigo.cicero@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 17, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)