Metabolic SyndromeEarly Phase 1RSNCT02323828
High Resistant Starch (RS) Cookies and Appetite Control
A Early Phase 1 study testing High RS cookies in people with Metabolic Syndrome, run by Catholic University of the Sacred Heart.
Trial summary
Evaluation of the effect of ingestion of high RS-cookies prepared from high amylose corn starch on food intake and appetite control of a cohort of healthy students. Cookies were prepared with increasing RS content and were fed to 18 healthy students in a blind trial versus a placebo. Read more about this study
- Who is it for?
- Ages 20 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- High RS cookies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jun 2013
- Phase
- Early Phase 1
- 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 20 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- self-reported healthy
- not suffering disorders of lipid metabolism and eating disorders
Who cannot join
- pregnant or breast-feeding
- consuming an energy-restricted diet
- vegan or vegetarians
About this study
Official title: Effect of High Resistant Starch-cookies on Food Ingestion and Appetite Control in a Cohort of Healthy Students
Evaluation of the effect of ingestion of high RS-cookies prepared from high amylose corn starch on food intake and appetite control of a cohort of healthy students. Cookies were prepared with increasing RS content and were fed to 18 healthy students in a blind trial versus a placebo.
Parameters of interest were: short and long time intake (ad libitum test meal and 12 h diet diaries, respectively).
- Conditions
- Metabolic Syndrome
- Being tested
- High RS cookies, Placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High RS cookiesDietary supplement
High RS cookies ingestion in healthy young adults
PlaceboDietary supplement
Placebo cookies ingestion in healthy young adults
| Study group | Role | What they receive |
|---|---|---|
| Investigational product | Experimental | The investigational products are RS starch cookies (40 g resistant starch) from high amylose maize starch.
Nine young healthy volunteers (males and females) consumed RS rich cookies (40 g RS) in two separate occasions. Receives: Dietary Supplement: High RS cookies |
| Placebo | Placebo comparator | The placebo products are common wheat-maize cookies (2 g RS). Nine young healthy volunteers (males and females) consumed placebo in two separate occasions. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of RS on appetite regulation
Ad libitum test meal
Measured: One day
Consumption of RS on appetite regulation
12-h diet diaries
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Rossi, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323828
- Sponsor's protocol ID
- 24238/14
- Acronym
- RS
- Status last verified
- Jan 2016
- First submitted
- 15 Dec 2014
- Last updated
- 27 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Resistant Starch-cookies on Food Ingestion and Appetite Control in a Cohort of Healthy Students
- ClinicalTrials.gov ID
- NCT02323828
- Acronym / sponsor ID
- RS / 24238/14
- Conditions
- Metabolic Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Dec 2014 (estimated)
- 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.
Evaluation of the effect of ingestion of high RS-cookies prepared from high amylose corn starch on food intake and appetite control of a cohort of healthy students. Cookies were prepared with increasing RS content and were fed to 18 healthy students in a blind trial versus a placebo.
Parameters of interest were: short and long time intake (ad libitum test meal and 12 h diet diaries, respectively).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational product | Experimental | Dietary Supplement: High RS cookiesThe investigational products are RS starch cookies (40 g resistant starch) from high amylose maize starch. Nine young healthy volunteers (males and females) consumed RS rich cookies (40 g RS) in two separate occasions. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo products are common wheat-maize cookies (2 g RS). Nine young healthy volunteers (males and females) consumed placebo in two separate occasions. |
Who may qualify
- Ages
- 20 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- self-reported healthy
- not suffering disorders of lipid metabolism and eating disorders
Key exclusion criteria (3 listed)
- pregnant or breast-feeding
- consuming an energy-restricted diet
- vegan or vegetarians
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 |
|---|---|---|
| High RS cookiesHigh RS cookies ingestion in healthy young adults | Dietary supplement | Investigational product |
| PlaceboPlacebo cookies ingestion in healthy young adults | Dietary supplement | Placebo |
Primary outcome
Consumption of RS on appetite regulation
Time frame: One day
Ad libitum test meal
Consumption of RS on appetite regulation
Time frame: One day
12-h diet diaries
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 27 Jan 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing High RS cookies in people with Metabolic Syndrome, run by Catholic University of the Sacred Heart.
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 3 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 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Consumption of RS on appetite regulation (time frame: One day). The study lists 2 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 27 Jan 2016.