Clinical Trials of Five Different Food Supplements With Restriction Diet in Adults (FOODSU)

University of Primorska

Status: Completed

Conditions: Hypertension; Inflammation; Hypercholesterolemia; Overweight and Obesity

Treatments: Dietary Supplement: IP4; Dietary Supplement: IP1; Dietary Supplement: IP2; Dietary Supplement: IP5; Dietary Supplement: IP3

Study type: Interventional

Funder types: Other

Identifiers

NCT05333315

Food supplements_CLINICAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 5 patient groups

Investigation Product 1 (IP1) in softchews form

Experimental group

Description:

0,5 g of glucomannan per softchew

Treatment:

Dietary Supplement: IP1

Investigation Product 2 (IP2) in powder form

Experimental group

Description:

Fiber of light Indian plantain, 7 g; glucomannan, 4,3 g; Inulin 2,5 g; Apple fiber, 1g; Choline, bitartrate 90 mg; Apple pectin,50 mg; Inositol, 40 mg

Treatment:

Dietary Supplement: IP2

Investigation Product 3 (IP3) in powder form and capsules form

Experimental group

Description:

POWDER: Plantain fibre 10 g; Inulin, 2 g; Apple fibre, 1,5 g; Root of pellitory, 500 mg; Apple pectin, 450 mg CAPSULE: Pumpkin seed extract, 300 mg; Garlic extract odourless, 300 mg; Artichoke leaf extract, 150 mg; Cumin seed extract, 150 mg; Peppermint leaf extract, 150 mg; Anise seed extract, 150 mg; Curcuma rhizome extract, 150 mg; Vitamin C, 42 mg; Zinc (in gluconate),10 mg; Vitamin B6, 1,5 mg

Treatment:

Dietary Supplement: IP3

Investigation Product 4 (IP4) in liquid form

Experimental group

Description:

LIQUID: Arabinogalactan, 700 mg; Inulin, 700 mg; Beta-glucans, 30 mg

Treatment:

Dietary Supplement: IP4

Investigation Product 5 (IP5) in two capsules form

Experimental group

Description:

CAPSULE 1:L-arginine, 100 mg; Choline bitartrate, 100 mg; L-carnosine, 100 mg; L-taurine, 100 mg; Soy lecithin, 50 mg; R-alfa lipoic acid,10 mg; Vitamin B6,2 mg; Folic acid, 200 µg; Vitamin D3, 5 µg; Vitamin B12, 2 µg CAPSULE 2: Schisandra fruit extract, 400 mg; Milk thistle fruit extract associated with phospholipids, 200 mg; Grape seed extract associated with phospholipids, 50 mg; Grape seed extract (Vitis vinifera),50 mg

Treatment:

Dietary Supplement: IP5