Overweight and ObesityNCT03423719
Evaluation of Fiit-ns® in Health-related Quality of Life Improvement in Overweight and Obese Subjects
A study testing Fiit-ns® in people with Overweight and Obesity, run by Fytexia at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effects of a 16-week supplementation with a polyphenol-rich extract, Fiit-ns®, on improvement of health-related quality of life (HR-QOL) of overweight and obese volunteers, as compared to placebo. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Fiit-ns®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2015to Sep 2017
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 25 kg/m2 ≤ Body Mass Index (BMI) ≤ 40 kg/m2
- 25-55 years old
Who cannot join
- Metabolic and/or chronic disease (diabetes, dyslipidemia, thyroiditis, inflammatory disease, immunological disease, asthma, anxiety, depression)
- Allergy to one of the ingredients of the supplement
- Current involvement of involvement within the 6 previous months in a chronic supplement program, chronic treatment program, weight loss program
- Smoking cessation
- High alcohol consumption
- Pregnancy
Show all 9Show fewer
- Breastfeeding
- Menopausal women
- Involvement in physical activity more than twice a week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a 16-week Supplementation With a Mediterranean Fruit and Vegetables Extract Rich in Polyphenols, Fiit-ns®, on Health-related Quality of Life of Overweight and Obese Volunteers: a Randomized, Double-blind, Parallel Trial
The purpose of this study is to evaluate the effects of a 16-week supplementation with a polyphenol-rich extract, Fiit-ns®, on improvement of health-related quality of life (HR-QOL) of overweight and obese volunteers, as compared to placebo. Previous beneficial results from a pilot study showed that the supplementation may improve quality of life as well as body composition. Based on such results, this pivotal study is statistically powered to detect significant differences in HR-QOL assessed with the Short Form-36 Health survey (SF-36) between baseline (Week 1, W1) and end of the supplementation period (Week 16, W16).
- Conditions
- Overweight and Obesity
- Being tested
- Fiit-ns®, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiit-ns®Dietary supplement
Fiit-ns® is a blend of polyphenol-rich extracts from grapefruit, grape, green tea, guarana and black carrot. It also provides Vitamin B3. Daily dosage is 900 mg in two 450 mg-capsules for 16 weeks.
PlaceboDietary supplement
Placebo product is 100% maltodextrin. Daily dosage is 900 mg in two 450 mg-capsules of identical appearance than the supplement capsule for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | This arm receives 2 x 450 mg capsules of Fiit-ns®, a blend of polyphenol-rich fruit and vegetables extracts, daily for 16 weeks. Receives: Dietary Supplement: Fiit-ns® |
| Placebo | Placebo comparator | This arm receives 2 x 450 mg capsules of Placebo, containing maltodextrin only, daily for 16 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health-related quality of life as assessed by the SF-36 Health Survey
Measured: Baseline (Week 1) and end of the supplementation period (Week 16)
Secondary outcomes (5)
Change in body weight
Change in body weight is measured with calibrated weighing scales
Measured: Baseline (Week 1) and end of the supplementation period (Week 16)
Change in waist circumference
Change is waist circumference is measured with a non-stretchable tape and used to calculate change in Index of Central Obesity (ICO)
Measured: Baseline (Week 1) and end of the supplementation period (Week 16)
Change in total body fat mass
Change in total body fat mass is measured with Dual-Energy X-ray Absorptiometry (DXA) scan
Measured: Baseline (Week 1) and end of the supplementation period (Week 16)
Change in trunk fat mass
Change in trunk fat mass is measured with Dual-Energy X-ray Absorptiometry (DXA) scan
Measured: Baseline (Week 1) and end of the supplementation period (Week 16 )
Change in physical activity level
Physical activity is assessed with International Physical Activity Questionnaire (IPAQ) IPAQ consists in 27 items that cover 4 different domains of physical activity (working, transportation, housework and gardening \& leisure-time) in terms of time spent during the 7 previous days.
Total score is the sum of the 4 domains and results are presented as an estimation of energy expenditure in metabolic equivalent-minutes per week (Met-min/week).
Measured: Baseline (Week 1) and end of the supplementation period (Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study startApr 2015
- Primary completionSep 2016
- Study completionSep 2017
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fytexia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro E Alcaraz Ramon, Principal investigator, UCAM (Universidad Catolica San Antonio de Murcia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423719
- Sponsor's protocol ID
- FITCT2015
- Status last verified
- Jan 2018
- First submitted
- 30 Jan 2018
- Last updated
- 6 Feb 2018
- Results posted
- 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 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a 16-week Supplementation With a Mediterranean Fruit and Vegetables Extract Rich in Polyphenols, Fiit-ns®, on Health-related Quality of Life of Overweight and Obese Volunteers: a Randomized, Double-blind, Parallel Trial
- ClinicalTrials.gov ID
- NCT03423719
- Acronym / sponsor ID
- FITCT2015
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- FytexiaIndustry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 6 Feb 2018 (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.
The purpose of this study is to evaluate the effects of a 16-week supplementation with a polyphenol-rich extract, Fiit-ns®, on improvement of health-related quality of life (HR-QOL) of overweight and obese volunteers, as compared to placebo. Previous beneficial results from a pilot study showed that the supplementation may improve quality of life as well as body composition. Based on such results, this pivotal study is statistically powered to detect significant differences in HR-QOL assessed with the Short Form-36 Health survey (SF-36) between baseline (Week 1, W1) and end of the supplementation period (Week 16, W16).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Dietary Supplement: Fiit-ns®This arm receives 2 x 450 mg capsules of Fiit-ns®, a blend of polyphenol-rich fruit and vegetables extracts, daily for 16 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis arm receives 2 x 450 mg capsules of Placebo, containing maltodextrin only, daily for 16 weeks. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 25 kg/m2 ≤ Body Mass Index (BMI) ≤ 40 kg/m2
- 25-55 years old
Key exclusion criteria (9 listed)
- Metabolic and/or chronic disease (diabetes, dyslipidemia, thyroiditis, inflammatory disease, immunological disease, asthma, anxiety, depression)
- Allergy to one of the ingredients of the supplement
- Current involvement of involvement within the 6 previous months in a chronic supplement program, chronic treatment program, weight loss program
- Smoking cessation
- High alcohol consumption
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 |
|---|---|---|
| Fiit-ns®Fiit-ns® is a blend of polyphenol-rich extracts from grapefruit, grape, green tea, guarana and black carrot. It also provides Vitamin B3. Daily dosage is 900 mg in two 450 mg-capsules for 16 weeks. | Dietary supplement | Verum |
| PlaceboPlacebo product is 100% maltodextrin. Daily dosage is 900 mg in two 450 mg-capsules of identical appearance than the supplement capsule for 16 weeks. | Dietary supplement | Placebo |
Primary outcome
Change in health-related quality of life as assessed by the SF-36 Health Survey
Time frame: Baseline (Week 1) and end of the supplementation period (Week 16)
5 secondary outcomes
Change in body weight
Time frame: Baseline (Week 1) and end of the supplementation period (Week 16)
Change in waist circumference
Time frame: Baseline (Week 1) and end of the supplementation period (Week 16)
Change in total body fat mass
Time frame: Baseline (Week 1) and end of the supplementation period (Week 16)
Change in trunk fat mass
Time frame: Baseline (Week 1) and end of the supplementation period (Week 16 )
Change in physical activity level
Time frame: Baseline (Week 1) and end of the supplementation period (Week 16)
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 6 Feb 2018.
- 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.
Pedro E Alcaraz Ramon principal investigator
UCAM (Universidad Catolica San Antonio de Murcia)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiit-ns® in people with Overweight and Obesity, run by Fytexia at 1 site in Spain.
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 2 inclusion and 9 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 6 Feb 2018. 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 Spain. 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. Some participants in this study may receive a placebo. 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 health-related quality of life as assessed by the SF-36 Health Survey (time frame: Baseline (Week 1) and end of the supplementation period (Week 16)). 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 6 Feb 2018.