NCT05333315

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Primorska · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2022-04-20
• Primary completion: 2022-07-01
• Completion: 2022-07-15
• First posted: 2022-04-18
• Last updated: 2022-07-19

Locations

1 site across 1 country: Slovenia