University of Primorska, Faculty of Health Sciences
Izola, 6310, Slovenia
NCT Number: NCT05333315
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.
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Notify Me40 year–65 year
All sexes
Interventional
Not applicable
Izola, 6310, Slovenia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
BMI > 25 kg/m2
Exclusion criteria
IP1: 2 softchews 3 times a day before meals with 1-2 glasses of water for eight weeks.
OTHER: Placebo
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: 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: Twice a day 20 mL half an hour before breakfast and half an hour before dinner for eight weeks.
OTHER:Placebo
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
Time frame: eight weeks
Changes in percentage of body fat from baseline to week eight measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
Time frame: eight weeks
Changes in body weight (in kilograms) from baseline to week eight measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
Time frame: eight weeks
Changes in waist circumference (in centimetres) from baseline to week eight measured with a flexible tape measure
Time frame: eight weeks
Changes in muscle mass (in kilograms) from baseline to week eight measured with bioelectrical bioelectrical impedance analysis (BIA) Tanita MC-980MA
Time frame: eight weeks
Changes in visceral fat rating (index) from baseline to week eight measured with bioelectrical bioelectrical impedance analysis (BIA) Tanita MC-980MA
Time frame: eight weeks
Changes in total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerides measured by biochemical analyzer Cobass
Time frame: eight weeks
Changes in diastolic and systolic blood pressure measured by blood pressure device (Omron M3)
Time frame: eight weeks
Changes in C-reactive protein levels measured by biochemical analyzer Cobass
Time frame: eight weeks
Changes in antioxidative potential determined by 1,1-diphenyl-2-picrylhydrazyl (DPPH) radical measurements.
University of Primorska
Other
The Effects of Five Different Food Supplements With Restriction Diet on the Components of the Metabolic Syndrome in Overweight and Obese Adults
Acronym: FOODSU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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