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

NCT ID: NCT05333315

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2022-07-15

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.

Conditions

Overweight and Obesity; Inflammation; Hypercholesterolemia; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Investigation Product 1 (IP1) in softchews form

0,5 g of glucomannan per softchew

Group Type: EXPERIMENTAL

IP1

Intervention Type: DIETARY_SUPPLEMENT

IP1: 2 softchews 3 times a day before meals with 1-2 glasses of water for eight weeks.

OTHER: Placebo

Investigation Product 2 (IP2) in powder form

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

Group Type: EXPERIMENTAL

IP2

Intervention Type: DIETARY_SUPPLEMENT

IP2: One bag per day mixed in 200 mL of cold water or tea and consumed immediately, on an empty stomach, half an hour before breakfast for eight weeks.

OTHER: Placebo

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

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

Group Type: EXPERIMENTAL

IP3

Intervention Type: DIETARY_SUPPLEMENT

IP3: One bag per day in the morning, dissolved in a glass of warm water and three capsules per day with a glass of water or tea (one capsule at breakfast, one at lunch and one at dinner) for eight weeks.

OTHER:Placebo

Investigation Product 4 (IP4) in liquid form

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

Group Type: EXPERIMENTAL

IP4

Intervention Type: DIETARY_SUPPLEMENT

IP4: Twice a day 20 mL half an hour before breakfast and half an hour before dinner for eight weeks.

OTHER:Placebo

Investigation Product 5 (IP5) in two capsules form

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

Group Type: EXPERIMENTAL

IP5

Intervention Type: DIETARY_SUPPLEMENT

IP5: Formula 1: One capsule per day at breakfast with a glass of water for eight weeks and Formula 2: Two capsules a day at breakfast and at dinner with a glass of water for eight weeks.

OTHER:Placebo

Interventions

IP1

IP1: 2 softchews 3 times a day before meals with 1-2 glasses of water for eight weeks.

OTHER: Placebo

Intervention Type: DIETARY_SUPPLEMENT

IP2

IP2: One bag per day mixed in 200 mL of cold water or tea and consumed immediately, on an empty stomach, half an hour before breakfast for eight weeks.

OTHER: Placebo

Intervention Type: DIETARY_SUPPLEMENT

IP3

IP3: One bag per day in the morning, dissolved in a glass of warm water and three capsules per day with a glass of water or tea (one capsule at breakfast, one at lunch and one at dinner) for eight weeks.

OTHER:Placebo

Intervention Type: DIETARY_SUPPLEMENT

IP4

IP4: Twice a day 20 mL half an hour before breakfast and half an hour before dinner for eight weeks.

OTHER:Placebo

Intervention Type: DIETARY_SUPPLEMENT

IP5

IP5: Formula 1: One capsule per day at breakfast with a glass of water for eight weeks and Formula 2: Two capsules a day at breakfast and at dinner with a glass of water for eight weeks.

OTHER:Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biostile d.o.o.

UNKNOWN

Sponsor Role: collaborator

University of Primorska

OTHER

Sponsor Role: lead

Responsible Party

Zala Jenko Praznikar

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Primorska, Faculty of Health Sciences

Izola, , Slovenia

Countries

Slovenia

Other Identifiers

Food supplements_CLINICAL

Identifier Type: -

Identifier Source: org_study_id