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

Not Applicable

Completed

• Conditions: Hypercholesterolemia; Overweight and Obesity; Inflammation; Hypertension
• Interventions: Dietary Supplement: IP1; Dietary Supplement: IP2; Dietary Supplement: IP4; Dietary Supplement: IP5; Dietary Supplement: IP3

• Registration Number: NCT05333315
• Lead Sponsor: University of Primorska

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.

Study Timeline

• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-18
• Study Start: 2022-04-20
• Status Verified: 2022-07
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-15
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigation Product 1 (IP1) in softchews form	IP1	0,5 g of glucomannan per softchew
Investigation Product 2 (IP2) in powder form	IP2	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
Investigation Product 4 (IP4) in liquid form	IP4	LIQUID: Arabinogalactan, 700 mg; Inulin, 700 mg; Beta-glucans, 30 mg
Investigation Product 5 (IP5) in two capsules form	IP5	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
Investigation Product 3 (IP3) in powder form and capsules form	IP3	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

Primary Outcome Measures

Name	Time	Method
Change in body fat	eight weeks	Changes in percentage of body fat from baseline to week eight measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA

Secondary Outcome Measures

Name	Time	Method
Changes in waist circumference	eight weeks	Changes in waist circumference (in centimetres) from baseline to week eight measured with a flexible tape measure
Blood pressure	eight weeks	Changes in diastolic and systolic blood pressure measured by blood pressure device (Omron M3)
Inflammation	eight weeks	Changes in C-reactive protein levels measured by biochemical analyzer Cobass
Change in body weight	eight weeks	Changes in body weight (in kilograms) from baseline to week eight measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
Changes in visceral fat rating	eight weeks	Changes in visceral fat rating (index) from baseline to week eight measured with bioelectrical bioelectrical impedance analysis (BIA) Tanita MC-980MA
Lipid profile	eight weeks	Changes in total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerides measured by biochemical analyzer Cobass
Changes in muscle mass	eight weeks	Changes in muscle mass (in kilograms) from baseline to week eight measured with bioelectrical bioelectrical impedance analysis (BIA) Tanita MC-980MA
Antioxidative potential	eight weeks	Changes in antioxidative potential determined by 1,1-diphenyl-2-picrylhydrazyl (DPPH) radical measurements.

Trial Locations

Locations (1)

University of Primorska, Faculty of Health Sciences; 🇸🇮 Izola, Slovenia