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

Hypertension Clinical Trial

— FOODSU  

Official title:

The Effects of Five Different Food Supplements With Restriction Diet on the Components of the Metabolic Syndrome in Overweight and Obese Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05333315
• Other study ID #: Food supplements_CLINICAL
• Status: Completed
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: July 15, 2022

Study information

• Verified date: July 2022
• Source: University of Primorska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 15, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hypertension
• Inflammation
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• IP1
IP1: 2 softchews 3 times a day before meals with 1-2 glasses of water for eight weeks. OTHER: Placebo
• 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
• 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
• IP4
IP4: Twice a day 20 mL half an hour before breakfast and half an hour before dinner for eight weeks. OTHER:Placebo
• 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

Locations

Country	Name	City	State
Slovenia	University of Primorska, Faculty of Health Sciences	Izola

Sponsors (2)

Lead Sponsor	Collaborator
University of Primorska	Biostile d.o.o.

Country where clinical trial is conducted

Slovenia, 

Outcome

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