Snack FoodNCT03420989
Elaboration of New Generation Snacks
A study testing Active snack food in people with Snack Food, run by Endocrinology and Clinical Nutrition Research Center, Spain at 1 site in Spain.
Trial summary
It is a blind randomized clinical trial of nutritional intervention in humans with a snack (seaweeds and carob), compared to a control snack without the bioactive ingredients studied but of similar nutritional composition, to evaluate the effect on the lipid profile, glycemia and Insulin resistance. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Snack Food
- What is being tested?
- Active snack food
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jan 2018to 18 Dec 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of metabolic syndrome by (Adult Treatment Panel III) criteria
Who cannot join
- consume supplements (vitamins, minerals or other dietary components),
- non-restrictive diet
- known chronic disease (eg diabetes, cardiovascular disease, Inflammatory diseases).
- active cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Novel Healthy Snacks Including Seaweeds and Carob Which Improve Risk Factors Associated With Metabolic Syndrome
It is a blind randomized clinical trial of nutritional intervention in humans with a snack (seaweeds and carob), compared to a control snack without the bioactive ingredients studied but of similar nutritional composition, to evaluate the effect on the lipid profile, glycemia and Insulin resistance.
Read the detailed description
The design will consist of a double-blind randomized study in adult subjects with metabolic syndrome, who will consume snack (enriched in seaweeds and carob) (50 g / day) vs. conventional snack for 8 weeks.
All the next parameters will be measured/calculated at basal time and after 8 weeks of intervention. The next biochemical parameters will be measured: Total cholesterol, LDL cholesterol, HDL, triglycerides will be analyzed using an enzyme-colorimetric method (Roche Diagnostics , Mannheim, Germany). Glucose will be determined by the method of glucose oxidase (Glucose analyzer 2, Beckman Instruments, Fullerton, California), insulin will be determined by Elisa (ELISA Diagnostic Corporation, Los Angeles, CA) and HOMA will be calculated by the formula Matthew et al. , 1985 (HOMA = (glucose * insulin) / 22.5). Body weight and fat mass by bioimpedance will be measured, too. Blood pressure (Systolic and diastolic blood pressure) will be measured, too. A diet records for 3 days and a satiety scale will be performed at the beginning and end of the intervention period.
- Conditions
- Snack Food
- Being tested
- Active snack food, Control snack food
- Keywords
- carob, seaweed, snack food, obese subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active snack foodOther
snack enriched with seaweeds and carob
Control snack foodOther
the same snack food without seaweeds and carob
| Study group | Role | What they receive |
|---|---|---|
| Active snack food | Active comparator | snack food with carob and seaweeds 50 gr per day Receives: Other: Active snack food |
| Control snack food | Placebo comparator | snack food without carob and seaweeds 50 gr per day Receives: Other: Control snack food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipoproteins
change in serum lipoprotein levels such as HDL-cholesterol and LDL cholesterol (mg/dl)
Measured: change from baseline HDL cholesterol (mg/dl) and LDL cholesterol (mg/dl )levels at 8 weeks
Secondary outcomes (4)
carbohydrate metabolism
change of seric carbohydrate parameters markers such as fasting glucose levels (mg/dl)
Measured: change from baseline fasting glucose levels (mg/dl) at 8 weeks
carbohydrate metabolism
change of seric carbohydrate parameters markers such as insulin levels (UI/L)
Measured: change from baseline insulin levels (UI/L) at 8 weeks
carbohydrate metabolism
change of seric carbohydrate parameters markers such as HOMA-Insulin resistance (units)
Measured: change from baseline HOMA-Insulin Resistance (units) at 8 weeks
Blood pressure
change of systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
Measured: change from baseline systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start18 Jan 2018
- Primary completion18 Sep 2019
- Study completion18 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Snack FoodStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endocrinology and Clinical Nutrition Research Center, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel de Luis Roman, Endocrinology and Clinical Nutrition Research Center, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420989
- Sponsor's protocol ID
- casve-nm-15-220
- Status last verified
- Feb 2023
- First submitted
- 17 Dec 2016
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Healthy Snacks Including Seaweeds and Carob Which Improve Risk Factors Associated With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03420989
- Acronym / sponsor ID
- casve-nm-15-220
- Conditions
- Snack Food
- Keywords
- carob, seaweed, snack food, obese subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Endocrinology and Clinical Nutrition Research Center, SpainUniversity, hospital or other
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 5 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.
It is a blind randomized clinical trial of nutritional intervention in humans with a snack (seaweeds and carob), compared to a control snack without the bioactive ingredients studied but of similar nutritional composition, to evaluate the effect on the lipid profile, glycemia and Insulin resistance.
Detailed description
The design will consist of a double-blind randomized study in adult subjects with metabolic syndrome, who will consume snack (enriched in seaweeds and carob) (50 g / day) vs. conventional snack for 8 weeks.
All the next parameters will be measured/calculated at basal time and after 8 weeks of intervention. The next biochemical parameters will be measured: Total cholesterol, LDL cholesterol, HDL, triglycerides will be analyzed using an enzyme-colorimetric method (Roche Diagnostics , Mannheim, Germany). Glucose will be determined by the method of glucose oxidase (Glucose analyzer 2, Beckman Instruments, Fullerton, California), insulin will be determined by Elisa (ELISA Diagnostic Corporation, Los Angeles, CA) and HOMA will be calculated by the formula Matthew et al. , 1985 (HOMA = (glucose * insulin) / 22.5). Body weight and fat mass by bioimpedance will be measured, too. Blood pressure (Systolic and diastolic blood pressure) will be measured, too. A diet records for 3 days and a satiety scale will be performed at the beginning and end of the intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active snack food | Active comparator | Other: Active snack foodsnack food with carob and seaweeds 50 gr per day |
| Control snack food | Placebo comparator | Other: Control snack foodsnack food without carob and seaweeds 50 gr per day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- presence of metabolic syndrome by (Adult Treatment Panel III) criteria
Key exclusion criteria (4 listed)
- consume supplements (vitamins, minerals or other dietary components),
- non-restrictive diet
- known chronic disease (eg diabetes, cardiovascular disease, Inflammatory diseases).
- active cancer
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 |
|---|---|---|
| Active snack foodsnack enriched with seaweeds and carob | Other | Active snack food |
| Control snack foodthe same snack food without seaweeds and carob | Other | Control snack food |
Primary outcome
Lipoproteins
Time frame: change from baseline HDL cholesterol (mg/dl) and LDL cholesterol (mg/dl )levels at 8 weeks
change in serum lipoprotein levels such as HDL-cholesterol and LDL cholesterol (mg/dl)
4 secondary outcomes
carbohydrate metabolism
Time frame: change from baseline fasting glucose levels (mg/dl) at 8 weeks
carbohydrate metabolism
Time frame: change from baseline insulin levels (UI/L) at 8 weeks
carbohydrate metabolism
Time frame: change from baseline HOMA-Insulin Resistance (units) at 8 weeks
Blood pressure
Time frame: change from baseline systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) at 8 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 8 Feb 2023.
- Individual participant dataSharing planned: No
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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 Active snack food in people with Snack Food, run by Endocrinology and Clinical Nutrition Research Center, Spain 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 1 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 8 Feb 2023. 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?
Lipoproteins (time frame: change from baseline HDL cholesterol (mg/dl) and LDL cholesterol (mg/dl )levels at 8 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 8 Feb 2023.