SatietyNCT04067466
Appetite Satisfaction and Short-term Satiety of Different Plant Compositions in the Adolescent Age Group
A study testing Fiber product in people with Satiety and Appetite, run by Laboratorios Ordesa at 1 site in Spain.
Trial summary
This study evaluates the satiating effect of two types of food supplements made from various types of fibres in the subsequent intake of other foods, in satiety, and in the regulation of hormones Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- What is being tested?
- Fiber product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jul 2017to 31 Dec 2018
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Men and women between 15 and 30 years old.
- Subjects with IMC<25 kg/m2
- Subjects who have a habit of having breakfast, lunch and dinner every day
- Subjects who are willing to comply with the study procedures
Who cannot join
- Subjects taht are taking any medicines that affect the appetite or food intake
- Presence of endocrine-metabolic diseases
- Eating disorders
- Subjects who are following a special diet
- Subjects who have changed their body weight by more than 10% in the last three months prior to the study
- Subjects who follow a restrictive dietary pattern such as vegetarians, gluten-free diets, weight loss diets, etc.
Trial locations and contacts
1 site in 1 country.
Spain1 site
GENUD Research Group, Universidad de Zaragoza
Zaragoza, Aragon, 50009
About this study
Official title: Effect on Appetite Satisfaction and Short-term Satiety of Different Plant Compositions in the Adolescent Age Group
This study evaluates the satiating effect of two types of food supplements made from various types of fibres in the subsequent intake of other foods, in satiety, and in the regulation of hormones
Read the detailed description
This study assessing the effect on appetite satisfaction and short-term satiety of different plant compositions in the adolescent age segment wants to assess the satiating effect of two types of food supplements made with various types of fibers (inulin, maltodextrins, guar gum and dehydrated plums) in the subsequent intake of other foods, in satiety, and in the regulation of hormones (ghrelin, leptin and insulin) and other peptides involved in the mechanisms of satiety
- Being tested
- Fiber product, Control product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber productDietary supplement
Fiber product with inulin, maltodextrin, gum guar and plum powder.
Control productDietary supplement
Placebo product with maltodextrin and plum powder
| Study group | Role | What they receive |
|---|---|---|
| Fiber product | Experimental | Fiber product: Inulin, maltodextrin, gum guar, plum powder Receives: Dietary Supplement: Fiber product |
| Control product | Placebo comparator | Maltodextrin, plum powder Receives: Dietary Supplement: Control product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of satiety using objective methods (blood analysis)
Biochemistry : glucose, urea, BUN, creatinin (all in mg/dL)
Measured: Change from week 1 to week 2
Assessment of satiety (blood analysis)
Biochemistry : GOT and GPT (UI/L)
Measured: Change from week 1 to week 2
Assessment of satiety using a subjective method (visual analogue scale)
The perceived feeling of satiety will be measured using the 100mm "Visual Analogue Scale" labeled at a far end with a "mark" to the left of "extremely hungry", and on the other with an "extremely satiated"."
Measured: Change from week 1 to week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start26 Jul 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SatietyStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis Moreno Aznar, Principal investigator, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067466
- Sponsor's protocol ID
- VEGYDOWN-15 (B)
- Status last verified
- Aug 2019
- First submitted
- 19 Aug 2019
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Appetite Satisfaction and Short-term Satiety of Different Plant Compositions in the Adolescent Age Group
- ClinicalTrials.gov ID
- NCT04067466
- Acronym / sponsor ID
- VEGYDOWN-15 (B)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Aug 2019 (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.
This study evaluates the satiating effect of two types of food supplements made from various types of fibres in the subsequent intake of other foods, in satiety, and in the regulation of hormones
Detailed description
This study assessing the effect on appetite satisfaction and short-term satiety of different plant compositions in the adolescent age segment wants to assess the satiating effect of two types of food supplements made with various types of fibers (inulin, maltodextrins, guar gum and dehydrated plums) in the subsequent intake of other foods, in satiety, and in the regulation of hormones (ghrelin, leptin and insulin) and other peptides involved in the mechanisms of satiety
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber product | Experimental | Dietary Supplement: Fiber productFiber product: Inulin, maltodextrin, gum guar, plum powder |
| Control product | Placebo comparator | Dietary Supplement: Control productMaltodextrin, plum powder |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Men and women between 15 and 30 years old.
- Subjects with IMC<25 kg/m2
- Subjects who have a habit of having breakfast, lunch and dinner every day
- Subjects who are willing to comply with the study procedures
Key exclusion criteria (6 listed)
- Subjects taht are taking any medicines that affect the appetite or food intake
- Presence of endocrine-metabolic diseases
- Eating disorders
- Subjects who are following a special diet
- Subjects who have changed their body weight by more than 10% in the last three months prior to the study
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 |
|---|---|---|
| Fiber productFiber product with inulin, maltodextrin, gum guar and plum powder. | Dietary supplement | Fiber product |
| Control productPlacebo product with maltodextrin and plum powder | Dietary supplement | Control product |
Primary outcome
Assessment of satiety using objective methods (blood analysis)
Time frame: Change from week 1 to week 2
Biochemistry : glucose, urea, BUN, creatinin (all in mg/dL)
Assessment of satiety (blood analysis)
Time frame: Change from week 1 to week 2
Biochemistry : GOT and GPT (UI/L)
Assessment of satiety using a subjective method (visual analogue scale)
Time frame: Change from week 1 to week 2
The perceived feeling of satiety will be measured using the 100mm "Visual Analogue Scale" labeled at a far end with a "mark" to the left of "extremely hungry", and on the other with an "extremely satiated"."
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 26 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Satiety
Active, not recruiting
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Supplementation of Gut-brain Axis (GLP-1)-Activating Carbohydrates for Increasing Satiety in Adolescents With Obesity
Obesity & Overweight
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Cerebellar TMS and Satiety in Prader-Willi Syndrome
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Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
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Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study
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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.
Luis Moreno Aznar principal investigator
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber product in people with Satiety and Appetite, run by Laboratorios Ordesa 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 4 inclusion and 6 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 26 Aug 2019. 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?
Assessment of satiety using objective methods (blood analysis) (time frame: Change from week 1 to week 2). The study lists 3 primary outcomes in all. 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 26 Aug 2019.