Overweight and ObesityFOODSUNCT05333315
Clinical Trials of Five Different Food Supplements With Restriction Diet in Adults
A study testing IP1, IP2 and IP3 in people with Overweight and Obesity and Inflammation, run by University of Primorska at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Inflammation, Hypercholesterolemia
- What is being tested?
- IP1, IP2 and IP3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSlovenia
- Study dates
- 20 Apr 2022to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- use of dietary supplements
- use of medication for any component of metabolic syndrome
- presence of inflammatory and/or autoimmune disorders
- pregnancy or lactating
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University of Primorska, Faculty of Health Sciences
Izola, 6310
About this study
Official title: The Effects of Five Different Food Supplements With Restriction Diet on the Components of the Metabolic Syndrome in Overweight and Obese 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.
Read the 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.
- Being tested
- IP1, IP2, IP3, IP4, IP5
- Keywords
- food supplements, diet, metabolic syndrome
- Medical subject headings
- Overweight, Obesity, Inflammation, Hypercholesterolemia, Hypertension, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IP1Dietary supplement
IP1: 2 softchews 3 times a day before meals with 1-2 glasses of water for eight weeks.
OTHER: Placebo
IP2Dietary 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
IP3Dietary 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
IP4Dietary supplement
IP4: Twice a day 20 mL half an hour before breakfast and half an hour before dinner for eight weeks.
OTHER:Placebo
IP5Dietary 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
| Study group | Role | What they receive |
|---|---|---|
| Investigation Product 1 (IP1) in softchews form | Experimental | 0,5 g of glucomannan per softchew Receives: Dietary Supplement: IP1 |
| Investigation Product 2 (IP2) in powder form | Experimental | Fiber of light Indian plantain, 7 g; glucomannan, 4,3 g; Inulin 2,5 g; Apple fiber, 1g; Choline, bitartrate 90 mg; Apple pectin,50 mg; Inositol, 40 mg Receives: Dietary Supplement: IP2 |
| Investigation Product 3 (IP3) in powder form and capsules form | Experimental | POWDER: Plantain fibre 10 g; Inulin, 2 g; Apple fibre, 1,5 g; Root of pellitory, 500 mg; Apple pectin, 450 mg CAPSULE: Pumpkin seed extract, 300 mg; Garlic extract odourless, 300 mg; Artichoke leaf extract, 150 mg; Cumin seed extract, 150 mg; Peppermint leaf extract, 150 mg; Anise seed extract, 150 mg; Curcuma rhizome extract, 150 mg; Vitamin C, 42 mg; Zinc (in gluconate),10 mg; Vitamin B6, 1,5 mg Receives: Dietary Supplement: IP3 |
| Investigation Product 4 (IP4) in liquid form | Experimental | LIQUID: Arabinogalactan, 700 mg; Inulin, 700 mg; Beta-glucans, 30 mg Receives: Dietary Supplement: IP4 |
| Investigation Product 5 (IP5) in two capsules form | Experimental | CAPSULE 1:L-arginine, 100 mg; Choline bitartrate, 100 mg; L-carnosine, 100 mg; L-taurine, 100 mg; Soy lecithin, 50 mg; R-alfa lipoic acid,10 mg; Vitamin B6,2 mg; Folic acid, 200 µg; Vitamin D3, 5 µg; Vitamin B12, 2 µg CAPSULE 2: Schisandra fruit extract, 400 mg; Milk thistle fruit extract associated with phospholipids, 200 mg; Grape seed extract associated with phospholipids, 50 mg; Grape seed extract (Vitis vinifera),50 mg Receives: Dietary Supplement: IP5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body fat
Changes in percentage of body fat from baseline to week eight measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
Measured: eight weeks
Secondary outcomes (8)
Change in body weight
Changes in body weight (in kilograms) from baseline to week eight measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
Measured: eight weeks
Changes in waist circumference
Changes in waist circumference (in centimetres) from baseline to week eight measured with a flexible tape measure
Measured: eight weeks
Changes in muscle mass
Changes in muscle mass (in kilograms) from baseline to week eight measured with bioelectrical bioelectrical impedance analysis (BIA) Tanita MC-980MA
Measured: eight weeks
Changes in visceral fat rating
Changes in visceral fat rating (index) from baseline to week eight measured with bioelectrical bioelectrical impedance analysis (BIA) Tanita MC-980MA
Measured: eight weeks
Lipid profile
Changes in total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerides measured by biochemical analyzer Cobass
Measured: eight weeks
Blood pressure
Changes in diastolic and systolic blood pressure measured by blood pressure device (Omron M3)
Measured: eight weeks
Inflammation
Changes in C-reactive protein levels measured by biochemical analyzer Cobass
Measured: eight weeks
Antioxidative potential
Changes in antioxidative potential determined by 1,1-diphenyl-2-picrylhydrazyl (DPPH) radical measurements.
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start20 Apr 2022
- Primary completion1 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Collaborators
- Biostile
- Responsible party
- Principal investigator, Zala Jenko Praznikar, University of Primorska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333315
- Sponsor's protocol ID
- Food supplements_CLINICAL
- Acronym
- FOODSU
- Status last verified
- Jul 2022
- First submitted
- 1 Apr 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Five Different Food Supplements With Restriction Diet on the Components of the Metabolic Syndrome in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT05333315
- Acronym / sponsor ID
- FOODSU / Food supplements_CLINICAL
- Keywords
- food supplements, diet, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Collaborators
- Biostile
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Investigation Product 1 (IP1) in softchews form | Experimental | Dietary Supplement: IP10,5 g of glucomannan per softchew |
| Investigation Product 2 (IP2) in powder form | Experimental | Dietary Supplement: IP2Fiber of light Indian plantain, 7 g; glucomannan, 4,3 g; Inulin 2,5 g; Apple fiber, 1g; Choline, bitartrate 90 mg; Apple pectin,50 mg; Inositol, 40 mg |
| Investigation Product 3 (IP3) in powder form and capsules form | Experimental | Dietary Supplement: IP3POWDER: Plantain fibre 10 g; Inulin, 2 g; Apple fibre, 1,5 g; Root of pellitory, 500 mg; Apple pectin, 450 mg CAPSULE: Pumpkin seed extract, 300 mg; Garlic extract odourless, 300 mg; Artichoke leaf extract, 150 mg; Cumin seed extract, 150 mg; Peppermint leaf extract, 150 mg; Anise seed extract, 150 mg; Curcuma rhizome extract, 150 mg; Vitamin C, 42 mg; Zinc (in gluconate),10 mg; Vitamin B6, 1,5 mg |
| Investigation Product 4 (IP4) in liquid form | Experimental | Dietary Supplement: IP4LIQUID: Arabinogalactan, 700 mg; Inulin, 700 mg; Beta-glucans, 30 mg |
| Investigation Product 5 (IP5) in two capsules form | Experimental | Dietary Supplement: IP5CAPSULE 1:L-arginine, 100 mg; Choline bitartrate, 100 mg; L-carnosine, 100 mg; L-taurine, 100 mg; Soy lecithin, 50 mg; R-alfa lipoic acid,10 mg; Vitamin B6,2 mg; Folic acid, 200 µg; Vitamin D3, 5 µg; Vitamin B12, 2 µg CAPSULE 2: Schisandra fruit extract, 400 mg; Milk thistle fruit extract associated with phospholipids, 200 mg; Grape seed extract associated with phospholipids, 50 mg; Grape seed extract (Vitis vinifera),50 mg |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- use of dietary supplements
- use of medication for any component of metabolic syndrome
- presence of inflammatory and/or autoimmune disorders
- pregnancy or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IP1IP1: 2 softchews 3 times a day before meals with 1-2 glasses of water for eight weeks. OTHER: Placebo | Dietary supplement | Investigation Product 1 (IP1) in softchews form |
| IP2IP2: 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 | Investigation Product 2 (IP2) in powder form |
| IP3IP3: 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 | Investigation Product 3 (IP3) in powder form and capsules form |
| IP4IP4: Twice a day 20 mL half an hour before breakfast and half an hour before dinner for eight weeks. OTHER:Placebo | Dietary supplement | Investigation Product 4 (IP4) in liquid form |
| IP5IP5: 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 | Dietary supplement | Investigation Product 5 (IP5) in two capsules form |
Primary outcome
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
8 secondary outcomes
Change in body weight
Time frame: eight weeks
Changes in waist circumference
Time frame: eight weeks
Changes in muscle mass
Time frame: eight weeks
Changes in visceral fat rating
Time frame: eight weeks
Lipid profile
Time frame: eight weeks
Blood pressure
Time frame: eight weeks
Inflammation
Time frame: eight weeks
Antioxidative potential
Time frame: eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IP1, IP2 and IP3 in people with Overweight and Obesity and Inflammation, run by University of Primorska at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body fat (time frame: eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.