Hypercholesterolemia, Hypertension, Inflammation, Overweight and Obesity
Conditions
Keywords
food supplements, diet, metabolic syndrome
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.
Interventions
DIETARY_SUPPLEMENTIP1
IP1: 2 softchews 3 times a day before meals with 1-2 glasses of water for eight weeks. OTHER: Placebo
DIETARY_SUPPLEMENTIP2
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
DIETARY_SUPPLEMENTIP3
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
DIETARY_SUPPLEMENTIP4
IP4: Twice a day 20 mL half an hour before breakfast and half an hour before dinner for eight weeks. OTHER:Placebo
DIETARY_SUPPLEMENTIP5
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
Sponsors
Biostile d.o.o.
University of Primorska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in waist circumference | eight weeks | Changes in waist circumference (in centimetres) from baseline to week eight measured with a flexible tape measure |
| 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 |
| 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 |
| 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 |
| 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 |
| Antioxidative potential | eight weeks | Changes in antioxidative potential determined by 1,1-diphenyl-2-picrylhydrazyl (DPPH) radical measurements. |
| Lipid profile | eight weeks | Changes in total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerides measured by biochemical analyzer Cobass |
Countries
Slovenia
Outcome results
None listed