AppetiteNCT05213559
Metabolic Responses After 12-week Hypocaloric Diet Supplemented With a Cereal-based Plant Protein Biscuit
A study testing wheat biscuit enriched with plant proteins and common wheat biscuit in people with Appetite, run by Harokopio University at 1 site in Greece.
Trial summary
Biscuits enjoy high popularity in the human diet and can be excellent snack alternatives and potential carriers of ingredients with appetite regulating properties. In the present study, the effects of a wheat biscuit enriched with plant proteins originated from legumes and seeds on gastrointestinal hormone responses… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite
- What is being tested?
- wheat biscuit enriched with plant proteins and common wheat biscuit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2022to 30 Aug 2023
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-diabetic women with overweight/obesity
- constant body weight for the last three months before enrollment
- standard dietary and physical activity habits
Who cannot join
- pregnancy
- lactation
- chronic medical illness
- use of nutritional supplements
- alcohol consumption >2 drinks per day
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens
Athens, Attica, 11527
About this study
Official title: Glucose and Gastrointestinal Hormone Responses of Subjects With Overweight/Obesity After 12-week Hypocaloric Dietary Intervention Supplemented With a Cereal-based Biscuit Enriched With Plant Proteins
Biscuits enjoy high popularity in the human diet and can be excellent snack alternatives and potential carriers of ingredients with appetite regulating properties. In the present study, the effects of a wheat biscuit enriched with plant proteins originated from legumes and seeds on gastrointestinal hormone responses of women with overweight/obesity after a hypocaloric dietary intervention will be examined.
Read the detailed description
Women with overweight/obesity will follow a 12-week dietary intervention supplemented with a cereal-based biscuit enriched with plant proteins or a common isocaloric wheat biscuit as a daily snack.
At the beginning and at the end of the dietary intervention postprandial metabolic responses, body weight reduction and subjective appetite ratings will be examined.
- Conditions
- Appetite
- Being tested
- wheat biscuit enriched with plant proteins, common wheat biscuit
- Keywords
- cereal-based biscuit enriched with plant proteins, appetite regulation, glycemic control, hormone responses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wheat biscuit enriched with plant proteinsOther
Postprandial glucose and appetite-regulating hormone responses of subjects with overweight/obesity after a 12-week dietary intervention with a biscuit enriched with plant proteins
common wheat biscuitOther
Postprandial glucose and appetite-regulating hormone responses of subjects with overweight/obesity after a 12-week dietary intervention with a common wheat biscuit
| Study group | Role | What they receive |
|---|---|---|
| wheat-based biscuit enriched with plant proteins | Experimental | Subjects follow a hypocaloric dietary intervention supplemented with certain amount of wheat-based biscuits enriched with plant proteins daily. Receives: Other: wheat biscuit enriched with plant proteins |
| wheat biscuit | Active comparator | Subjects follow a hypocaloric dietary intervention supplemented with certain isocaloric amount of common wheat biscuits daily. Receives: Other: common wheat biscuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in postprandial glucose response
change in glucose iAUC and glucose concentration at certain time points at the end of the dietary intervention compared to the beginning.
Measured: Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.
Secondary outcomes (1)
change in postprandial appetite regulating hormone responses
changes in iAUCs and concentrations at certain time points at the end of the dietary intervention compared to the beginning.
Measured: Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Feb 2022
- Primary completion30 Apr 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppetiteStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Principal investigator, Amalia Yanni, Harokopio University
- Investigators
- Alexander Kokkinos, Professor, Study chair, National and Kapodistrian University of AthensAmalia Yanni, PhD, Principal investigator, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213559
- Sponsor's protocol ID
- 26.14-2-2020
- Status last verified
- Sep 2023
- First submitted
- 20 Jan 2022
- Last updated
- 28 Sep 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose and Gastrointestinal Hormone Responses of Subjects With Overweight/Obesity After 12-week Hypocaloric Dietary Intervention Supplemented With a Cereal-based Biscuit Enriched With Plant Proteins
- ClinicalTrials.gov ID
- NCT05213559
- Acronym / sponsor ID
- 26.14-2-2020
- Conditions
- Appetite
- Keywords
- cereal-based biscuit enriched with plant proteins, appetite regulation, glycemic control, hormone responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 28 Jan 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.
Biscuits enjoy high popularity in the human diet and can be excellent snack alternatives and potential carriers of ingredients with appetite regulating properties. In the present study, the effects of a wheat biscuit enriched with plant proteins originated from legumes and seeds on gastrointestinal hormone responses of women with overweight/obesity after a hypocaloric dietary intervention will be examined.
Detailed description
Women with overweight/obesity will follow a 12-week dietary intervention supplemented with a cereal-based biscuit enriched with plant proteins or a common isocaloric wheat biscuit as a daily snack.
At the beginning and at the end of the dietary intervention postprandial metabolic responses, body weight reduction and subjective appetite ratings will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wheat-based biscuit enriched with plant proteins | Experimental | Other: wheat biscuit enriched with plant proteinsSubjects follow a hypocaloric dietary intervention supplemented with certain amount of wheat-based biscuits enriched with plant proteins daily. |
| wheat biscuit | Active comparator | Other: common wheat biscuitSubjects follow a hypocaloric dietary intervention supplemented with certain isocaloric amount of common wheat biscuits daily. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- non-diabetic women with overweight/obesity
- constant body weight for the last three months before enrollment
- standard dietary and physical activity habits
Key exclusion criteria (5 listed)
- pregnancy
- lactation
- chronic medical illness
- use of nutritional supplements
- alcohol consumption >2 drinks per day
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 |
|---|---|---|
| wheat biscuit enriched with plant proteinsPostprandial glucose and appetite-regulating hormone responses of subjects with overweight/obesity after a 12-week dietary intervention with a biscuit enriched with plant proteins | Other | wheat-based biscuit enriched with plant proteins |
| common wheat biscuitPostprandial glucose and appetite-regulating hormone responses of subjects with overweight/obesity after a 12-week dietary intervention with a common wheat biscuit | Other | wheat biscuit |
Primary outcome
change in postprandial glucose response
Time frame: Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.
change in glucose iAUC and glucose concentration at certain time points at the end of the dietary intervention compared to the beginning.
1 secondary outcome
change in postprandial appetite regulating hormone responses
Time frame: Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.
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 28 Sep 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.
Alexander Kokkinos, Professor study chair
National and Kapodistrian University of Athens
Amalia Yanni, PhD principal investigator
Harokopio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wheat biscuit enriched with plant proteins and common wheat biscuit in people with Appetite, run by Harokopio University at 1 site in Greece.
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 5 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 28 Sep 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 Greece. 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 postprandial glucose response (time frame: Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.). 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 28 Sep 2023.