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NCT Number: NCT05333315

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IP1

Dietary Supplement

IP1: 2 softchews 3 times a day before meals with 1-2 glasses of water for eight weeks.

OTHER: Placebo

IP2

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

IP4: Twice a day 20 mL half an hour before breakfast and half an hour before dinner for eight weeks.

OTHER:Placebo

IP5

Dietary Supplement

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

Primary outcomes

  1. Change in body fat

    Time frame: eight weeks

    Changes in percentage of body fat from baseline to week eight measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA

Secondary outcomes

  1. Change in body weight

    Time frame: eight weeks

    Changes in body weight (in kilograms) from baseline to week eight measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA

  2. Changes in waist circumference

    Time frame: eight weeks

    Changes in waist circumference (in centimetres) from baseline to week eight measured with a flexible tape measure

  3. Changes in muscle mass

    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

  4. Changes in visceral fat rating

    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

  5. Lipid profile

    Time frame: eight weeks

    Changes in total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerides measured by biochemical analyzer Cobass

  6. Blood pressure

    Time frame: eight weeks

    Changes in diastolic and systolic blood pressure measured by blood pressure device (Omron M3)

  7. Inflammation

    Time frame: eight weeks

    Changes in C-reactive protein levels measured by biochemical analyzer Cobass

  8. Antioxidative potential

    Time frame: eight weeks

    Changes in antioxidative potential determined by 1,1-diphenyl-2-picrylhydrazyl (DPPH) radical measurements.

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Collaborators

  • Biostile

Registry information

Official study title

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

Acronym: FOODSU

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2022
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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