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

NCT05333315 | Completed

• 1 other identifier: Food supplements_CLINICAL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Inflammation; Hypercholesterolemia; Hypertension

Keywords

food supplements; diet; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Change in body fat

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

  eight weeks

Secondary Outcomes (8)

• Change in body weight

  eight weeks

• Changes in waist circumference

  eight weeks

• Changes in muscle mass

  eight weeks

• Changes in visceral fat rating

  eight weeks

• Lipid profile

  eight weeks

Study Arms (5)

Investigation Product 1 (IP1) in softchews form

EXPERIMENTAL

0,5 g of glucomannan per softchew

Dietary Supplement: IP1

Investigation Product 2 (IP2) in powder form

EXPERIMENTAL

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

Dietary Supplement: IP2

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

EXPERIMENTAL

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

Dietary Supplement: IP3

Investigation Product 4 (IP4) in liquid form

EXPERIMENTAL

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

Dietary Supplement: IP4

Investigation Product 5 (IP5) in two capsules form

EXPERIMENTAL

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

Dietary Supplement: IP5

Interventions

IP1 DIETARY_SUPPLEMENT

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

Investigation Product 1 (IP1) in softchews form

IP2 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 2 (IP2) in powder form

IP3 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 3 (IP3) in powder form and capsules form

IP4 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 4 (IP4) in liquid form

IP5 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

Investigation Product 5 (IP5) in two capsules form

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Primorska: lead
• Biostile d.o.o.: collaborator

Study Sites (1)

University of Primorska, Faculty of Health Sciences

Izola, 6310, Slovenia

Location

MeSH Terms

Conditions

Overweight; Obesity; Inflammation; Hypercholesterolemia; Hypertension; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 18, 2022
• Study Start: April 20, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 15, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

SL (1)