Clinical Trials of Five Different Food Supplements With Restriction Diet in Adults
Condition: Overweight and Obesity; Inflammation; Hypercholesterolemia; Hypertension
MeSH terms: Overweight; Hypercholesterolemia; Inflammation
Study type: Interventional

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.
    

Intervention name(s): IP1; IP2; IP3; IP4; IP5
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: food supplements; diet; metabolic syndrome