Clinical trial NCT05333315: Clinical Trials of Five Different Food Supplements With Restriction Diet in Adults
Official title: The Effects of Five Different Food Supplements With Restriction Diet on the Components of the Metabolic Syndrome in Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Inflammation
Hypercholesterolemia
Hypertension
Keywords: food supplements
diet
metabolic syndrome
Lead sponsor: University of Primorska
Sponsor class: OTHER
Collaborators: name: Biostile d.o.o.
First posted: 2022-04-18
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In recent years, dietary supplement are of great interest for the improvement of human health. This study is designed as a parallel, randomized, double blind study exploring the efficacy of two months daily oral dosing of five different food supplements together with diet restriction in 120 otherwise healthy overweight or obese adults on different biochemical and anthropometric parameters.

Detailed description: The incidence of obesity has been rapidly increasing, and this condition has become a major public health threat, since it is strongly linked with increased risk for several diseases including type 2 diabetes, cardiovascular disease, cancer and brain aging. Obesity and overweight are chronic disorders of multifactorial origin that are characterized by high oxidative status and by low chronic inflammation. Thus far, molecular mechanisms underlying obesity and obesity-related metabolic disorders have not been fully clarified, and effective therapeutic approaches to lower inflammation and oxidative stress are currently of general interest.

In recent years, dietary supplement and are of interest for the improvement of human health. This study is designed as a parallel, randomized, double blind study exploring the efficacy of two months daily oral dosing of five different food supplements together with diet restriction in 120 otherwise healthy overweight or obese adults on different biochemical (lipid profile, glucose, C-reactive protein, bilirubin, alanine aminotransferase, etc), and anthropometric parameters (body mass, the percentage of body fat, visceral fat index, etc,...). Food supplements are mainly composed of different fiber and other bioactive compounds.

Eligibility criteria: Inclusion Criteria: BMI \> 25 kg/m2

* BMI \> 25 kg/m2
* personally signed and dated informed consent form
* ability to understand and willingness to comply with all protocols required visits assessments and interventions

Exclusion Criteria:

* use of dietary supplements
* use of medication for any component of metabolic syndrome
* presence of inflammatory and/or autoimmune disorders
* pregnancy or lactating

Primary outcomes:
measure: Change in body fat
timeFrame: eight weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: eight weeks
measure: Changes in waist circumference
timeFrame: eight weeks
measure: Changes in muscle mass
timeFrame: eight weeks
measure: Changes in visceral fat rating
timeFrame: eight weeks
measure: Lipid profile
timeFrame: eight weeks
measure: Blood pressure
timeFrame: eight weeks
measure: Inflammation
timeFrame: eight weeks
measure: Antioxidative potential
timeFrame: eight weeks
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska, Faculty of Health Sciences
Study officials:
References: