ObesityPhase 2NCT02575131
Breakfast Test Products and Acute Satiety Scores
A Phase 2 study testing whole wheat bread yeast basis, Oatmeal and Cheerios in people with Obesity, run by TNO at 1 site in Netherlands.
Trial summary
Rationale: The worldwide prevalence of obesity increases rapidly, and at the moment there are more overweight than underweight people in the world. This is partly caused by increased energy, or food intake. One of the physiological factors regulating the food intake pattern is satiety. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- whole wheat bread yeast basis, Oatmeal and Cheerios
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2015to Jul 2016
- Phase
- Phase 2
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subjects aged 18-50 years;
- BMI: 22-32 kg/m2;
- Written consent regarding participation after full information regarding all details of the study;
- Normal Dutch eating habits (consuming mostly three main meals per day; used to eat bread for lunch; used to consume dietary fibres; like the test products (P9619 F02));
- Normal dietary eating behaviour (non-restrained eaters, estimated with the Dutch Eating Behaviour Questionnaire; P9619 F06);
- Healthy as assessed by the Health and Lifestyle questionnaire (P9619 F02);
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- Subjects with a normal dietary fibre intake (between 10-30 grams/day) (P9619 F07);
- Voluntary participation;
- Willing to comply with study procedures;
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data by TNO;
- Have a laptop with adequate internet access at home and experience how to use it, and willing to use and bring it to TNO.
Who cannot join
- On-going or recent treatment for diabetes, hypertension, coronary heart disease, psychiatric conditions, inflammatory chronic disease - rheumatoid arthritis, Crohn Disease, ulcerous colitis, chronic constipation, eating disorders;
- Reported postmenopausal;
- Having menstruation problems, e.g. PCOS;
- Reported to be on a slimming diet or other dietary treatment (currently or during last two months, like vegetarian diet, lactose restricted diet etc.);
- On-going use of any slimming preparations;
- Any kind of dysfunction of digestive tract, food allergies/intolerances related to the supplied test products (like gluten intolerance), chronic constipation, recent/actual gastroenteritis;
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- Reported unexplained weight loss or gain of > 2 kg in the three months prior to the pre-study screening
- Smoking;
- Subjects with a high level of physical activity (> 5h intense sporting activity/week);
- Heavy alcohol consumers, no more than 14 units per week (1 unit represents 1 standard glass/portion of alcohol, independent of the type of alcoholic drink);
- Physical, mental or practical limitations in using computerized systems;
- Partner or first or second-degree relative from TNO personnel stationed at TNO Zeist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breakfast Test Products on Acute Satiety Scores in Different Test Conditions
Rationale: The worldwide prevalence of obesity increases rapidly, and at the moment there are more overweight than underweight people in the world. This is partly caused by increased energy, or food intake. One of the physiological factors regulating the food intake pattern is satiety. Though the regulation of food intake has been studied quite extensively, the underlying mechanisms are not well elucidated yet and still new factors involved in this regulation are being found. Therefore, in this study the investigators aim to develop an in vitro screening tool combined with an in silico model for prediction of satiety, for cost- and time - effective screening of satiating properties of new and existing complex food products and (functional) ingredients, based on actual satiety scores measured. A second aim of the Wholegrain Satiety project is to evaluate satiating properties of different types of wholegrain breads and other oat based products, both for validation purposes and to strengthen the scientific evidence for health benefits of wholegrain products. As part of this study, acute satiety scores after consumption of various breakfast products in well-controlled clinical conditions will be compared with satiety scores obtained in 'at home' test conditions.
Objective: The current study aims to compare the acute satiety effect of carbohydrate breakfast products.
Read the detailed description
In the present study the investigators will conduct a clinical trial in which a standard protocol will be used to examine five different breakfasts (different in type: breakfast cereals and bread, and macronutrient composition) with satiating ingredients which will reveal actual human satiety scores. The visual analogue scales used for determination of satiety feelings is an accepted method by EFSA and studied extensively. It is used by TNO in an earlier carbohydrate containing breakfast experiment.
Subjects may feel and eat differently at home. Especially since supervision by a researcher is known to influence behavior of participants. Self-measuring has the potential of giving more reliable estimates of intervention effects. Therefore, it is interesting to repeat the tests that are performed in the clinical unit, in an 'at home' condition, because that is the place consumers eat their breakfast habitually (= ecological validity).
Study design: The study is designed as an open, randomized, controlled, cross-over trial.
Study population: Forty healthy, lean and overweight, non-restrained eating women.
Intervention: The intervention consists of five different normal breakfasts (normal amount, about 243-355 kCal; bread, cooked oatmeal, cereal meal, fried egg with bread) provided as a breakfast in the metabolic ward and at home.
Main study parameters/endpoints: Satiety scores will be obtained with visual analogue rating scales (VAS). Subjects will rate hunger feelings, fullness feelings, satiety feelings, desire to eat and rate their prospective food consumption, before and multiple times after consumption of a breakfast. A test session lasts for four hours (t = 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes).
In the controlled conditions at TNO, finger pricks will be performed at t = 0, 30, 60, 90 and 120 minutes after breakfast consumption to measure blood glucose.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will consume prescribed, standardized breakfast products; five times at a clinical unit and five times at home. No risk is associated with intake of the test products. The VAS questionnaire will be filled in on the laptop multiple times on all test days (at home and at the clinic). No risk or real burden is of concern in this study. Subjects will perform finger pricks five times in each controlled session at TNO, what is known as a minimally invasive technique to obtain drops of blood.
- Conditions
- Obesity
- Being tested
- whole wheat bread yeast basis, Oatmeal, Cheerios, whole wheat sourdough bread, standard breakfast
- Keywords
- satiety, overweight, breakfast, ecological validity
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole wheat bread yeast basisOther
OatmealOther
CheeriosOther
whole wheat sourdough breadOther
standard breakfastOther
| Study group | Role | What they receive |
|---|---|---|
| TNO whole wheat bread yeast basis | Experimental | NBC-1: four slices of whole wheat bread yeast basis (98 grams) spread with 3 cups low-fat margarine (total 30 grams) consumed with 200 mL of black coffee (without milk and sugar) or 200 mL tea (no sugar) or 200 mL of water at TNO Receives: Other: whole wheat bread yeast basis |
| TNO whole wheat sourdough bread | Active comparator | NBC-2- four slices of whole wheat sourdough bread (98 grams) with 3 cups low-fat margarine (total 30 grams) consumed with 200 mL of black coffee (without milk and sugar) or 200 mL tea (no sugar) or 200 mL of water. at TNO Receives: Other: whole wheat sourdough bread |
| TNO Oatmeal | Experimental | PepsiCo, Inc.-1 - One portion of Steel Cut oatmeal: 66.8 grams of oats boiled for 25 minutes in 500 grams of water and consumed with 307 grams of skimmed milk at TNO Receives: Other: Oatmeal |
| TNO original Cheerios | Active comparator | PepsiCo, Inc.-2 - One portion of original Cheerios (ready to eat cereal): 70 grams prepared with 307 grams of skimmed milk and consumed with about 275 grams of water at TNO Receives: Other: Cheerios |
| TNO standard breakfast | Experimental | TNO breakfast: one slice of white bread with a fried egg and 200 mL orange juice. With spray oil a frying pan is prepared to fry an egg (medium size).
The breakfast is consumed at TNO Receives: Other: standard breakfast |
| Home whole wheat bread yeast basis | Experimental | NBC-1: four slices of whole wheat bread yeast basis (98 grams) spread with 3 cups low-fat margarine (total 30 grams) consumed with 200 mL of black coffee (without milk and sugar) or 200 mL tea (no sugar) or 200 mL of water at home Receives: Other: whole wheat bread yeast basis |
| Home whole wheat sourdough bread | Active comparator | NBC-2- four slices of whole wheat sourdough bread (98 grams) with 3 cups low-fat margarine (total 30 grams) consumed with 200 mL of black coffee (without milk and sugar) or 200 mL tea (no sugar) or 200 mL of water at home Receives: Other: whole wheat sourdough bread |
| Home Oatmeal | Experimental | PepsiCo, Inc.-1 - One portion of Steel Cut oatmeal: 66.8 grams of oats boiled for 25 minutes in 500 grams* of water and consumed with 307 grams of skimmed milk at home Receives: Other: Oatmeal |
| Home original Cheerios | Active comparator | PepsiCo, Inc.-2 - One portion of original Cheerios (ready to eat cereal): 70 grams prepared with 307 grams of skimmed milk and consumed with about 275 grams of water at home Receives: Other: Cheerios |
| Home standard breakfast | Experimental | one slice of white bread with a fried egg and 200 mL orange juice. With spray oil a frying pan is prepared to fry an egg (medium size).
The breakfast is consumed at home Receives: Other: standard breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hunger and satiety feelings for different compositions of breakfasts
Response in hunger and satiety feelings due to breakfast consumption over time (four hours) will be measured with a visual analogue rating scale varying of no hunger (0 mm) to very hungry (100 mm)
Measured: four hours
Secondary outcomes (2)
Level of control of the conduct (controlled at TNO versus less control at home)
The differences in hunger and satiety scores measured with visual analogue rating scales will be monitored for four hours after breakfast consumption at TNO (controlled setting) versus at home (less control)
Measured: Four hour follow-up on hunger and satiety feelings after each breakfast session
Blood glucose
In the controlled condition at TNO the blood glucose response will be monitored with finger pricks and direct blood glucose measurement.
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Collaborators
- Nederlands Bakkerij Centrum, PepsiCo, Inc.
- Responsible party
- Principal investigator, W.J. Pasman, TNO
- Investigators
- Wilrike J Pasman, PhD, Principal investigator, TNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575131
- Sponsor's protocol ID
- 9619
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2015
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Blundell J, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. Appetite control: methodological aspects of the evaluation of foods. Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29.
PubMed 20122136Raben A, Tagliabue A, Astrup A. The reproducibility of subjective appetite scores. Br J Nutr. 1995 Apr;73(4):517-30. doi: 10.1079/bjn19950056.
PubMed 7794869Pasman WJ, Blokdijk VM, Bertina FM, Hopman WP, Hendriks HF. Effect of two breakfasts, different in carbohydrate composition, on hunger and satiety and mood in healthy men. Int J Obes Relat Metab Disord. 2003 Jun;27(6):663-8. doi: 10.1038/sj.ijo.0802284.
PubMed 12833109Marschollek M, Gietzelt M, Schulze M, Kohlmann M, Song B, Wolf KH. Wearable sensors in healthcare and sensor-enhanced health information systems: all our tomorrows? Healthc Inform Res. 2012 Jun;18(2):97-104. doi: 10.4258/hir.2012.18.2.97. Epub 2012 Jun 30.
PubMed 22844645
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breakfast Test Products on Acute Satiety Scores in Different Test Conditions
- ClinicalTrials.gov ID
- NCT02575131
- Acronym / sponsor ID
- 9619
- Conditions
- Obesity
- Keywords
- satiety, overweight, breakfast, ecological validity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- TNOUniversity, hospital or other
- Collaborators
- Nederlands Bakkerij Centrum, PepsiCo, Inc.
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 14 Oct 2015 (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.
Rationale: The worldwide prevalence of obesity increases rapidly, and at the moment there are more overweight than underweight people in the world. This is partly caused by increased energy, or food intake. One of the physiological factors regulating the food intake pattern is satiety. Though the regulation of food intake has been studied quite extensively, the underlying mechanisms are not well elucidated yet and still new factors involved in this regulation are being found. Therefore, in this study the investigators aim to develop an in vitro screening tool combined with an in silico model for prediction of satiety, for cost- and time - effective screening of satiating properties of new and existing complex food products and (functional) ingredients, based on actual satiety scores measured. A second aim of the Wholegrain Satiety project is to evaluate satiating properties of different types of wholegrain breads and other oat based products, both for validation purposes and to strengthen the scientific evidence for health benefits of wholegrain products. As part of this study, acute satiety scores after consumption of various breakfast products in well-controlled clinical conditions will be compared with satiety scores obtained in 'at home' test conditions.
Objective: The current study aims to compare the acute satiety effect of carbohydrate breakfast products.
Detailed description
In the present study the investigators will conduct a clinical trial in which a standard protocol will be used to examine five different breakfasts (different in type: breakfast cereals and bread, and macronutrient composition) with satiating ingredients which will reveal actual human satiety scores. The visual analogue scales used for determination of satiety feelings is an accepted method by EFSA and studied extensively. It is used by TNO in an earlier carbohydrate containing breakfast experiment.
Subjects may feel and eat differently at home. Especially since supervision by a researcher is known to influence behavior of participants. Self-measuring has the potential of giving more reliable estimates of intervention effects. Therefore, it is interesting to repeat the tests that are performed in the clinical unit, in an 'at home' condition, because that is the place consumers eat their breakfast habitually (= ecological validity).
Study design: The study is designed as an open, randomized, controlled, cross-over trial.
Study population: Forty healthy, lean and overweight, non-restrained eating women.
Intervention: The intervention consists of five different normal breakfasts (normal amount, about 243-355 kCal; bread, cooked oatmeal, cereal meal, fried egg with bread) provided as a breakfast in the metabolic ward and at home.
Main study parameters/endpoints: Satiety scores will be obtained with visual analogue rating scales (VAS). Subjects will rate hunger feelings, fullness feelings, satiety feelings, desire to eat and rate their prospective food consumption, before and multiple times after consumption of a breakfast. A test session lasts for four hours (t = 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes).
In the controlled conditions at TNO, finger pricks will be performed at t = 0, 30, 60, 90 and 120 minutes after breakfast consumption to measure blood glucose.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will consume prescribed, standardized breakfast products; five times at a clinical unit and five times at home. No risk is associated with intake of the test products. The VAS questionnaire will be filled in on the laptop multiple times on all test days (at home and at the clinic). No risk or real burden is of concern in this study. Subjects will perform finger pricks five times in each controlled session at TNO, what is known as a minimally invasive technique to obtain drops of blood.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| TNO whole wheat bread yeast basis | Experimental | Other: whole wheat bread yeast basisNBC-1: four slices of whole wheat bread yeast basis (98 grams) spread with 3 cups low-fat margarine (total 30 grams) consumed with 200 mL of black coffee (without milk and sugar) or 200 mL tea (no sugar) or 200 mL of water at TNO |
| TNO whole wheat sourdough bread | Active comparator | Other: whole wheat sourdough breadNBC-2- four slices of whole wheat sourdough bread (98 grams) with 3 cups low-fat margarine (total 30 grams) consumed with 200 mL of black coffee (without milk and sugar) or 200 mL tea (no sugar) or 200 mL of water. at TNO |
| TNO Oatmeal | Experimental | Other: OatmealPepsiCo, Inc.-1 - One portion of Steel Cut oatmeal: 66.8 grams of oats boiled for 25 minutes in 500 grams of water and consumed with 307 grams of skimmed milk at TNO |
| TNO original Cheerios | Active comparator | Other: CheeriosPepsiCo, Inc.-2 - One portion of original Cheerios (ready to eat cereal): 70 grams prepared with 307 grams of skimmed milk and consumed with about 275 grams of water at TNO |
| TNO standard breakfast | Experimental | Other: standard breakfastTNO breakfast: one slice of white bread with a fried egg and 200 mL orange juice. With spray oil a frying pan is prepared to fry an egg (medium size). The breakfast is consumed at TNO |
| Home whole wheat bread yeast basis | Experimental | Other: whole wheat bread yeast basisNBC-1: four slices of whole wheat bread yeast basis (98 grams) spread with 3 cups low-fat margarine (total 30 grams) consumed with 200 mL of black coffee (without milk and sugar) or 200 mL tea (no sugar) or 200 mL of water at home |
| Home whole wheat sourdough bread | Active comparator | Other: whole wheat sourdough breadNBC-2- four slices of whole wheat sourdough bread (98 grams) with 3 cups low-fat margarine (total 30 grams) consumed with 200 mL of black coffee (without milk and sugar) or 200 mL tea (no sugar) or 200 mL of water at home |
| Home Oatmeal | Experimental | Other: OatmealPepsiCo, Inc.-1 - One portion of Steel Cut oatmeal: 66.8 grams of oats boiled for 25 minutes in 500 grams* of water and consumed with 307 grams of skimmed milk at home |
| Home original Cheerios | Active comparator | Other: CheeriosPepsiCo, Inc.-2 - One portion of original Cheerios (ready to eat cereal): 70 grams prepared with 307 grams of skimmed milk and consumed with about 275 grams of water at home |
| Home standard breakfast | Experimental | Other: standard breakfastone slice of white bread with a fried egg and 200 mL orange juice. With spray oil a frying pan is prepared to fry an egg (medium size). The breakfast is consumed at home |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Female subjects aged 18-50 years;
- BMI: 22-32 kg/m2;
- Written consent regarding participation after full information regarding all details of the study;
- Normal Dutch eating habits (consuming mostly three main meals per day; used to eat bread for lunch; used to consume dietary fibres; like the test products (P9619 F02));
- Normal dietary eating behaviour (non-restrained eaters, estimated with the Dutch Eating Behaviour Questionnaire; P9619 F06);
Key exclusion criteria (12 listed)
- On-going or recent treatment for diabetes, hypertension, coronary heart disease, psychiatric conditions, inflammatory chronic disease - rheumatoid arthritis, Crohn Disease, ulcerous colitis, chronic constipation, eating disorders;
- Reported postmenopausal;
- Having menstruation problems, e.g. PCOS;
- Reported to be on a slimming diet or other dietary treatment (currently or during last two months, like vegetarian diet, lactose restricted diet etc.);
- On-going use of any slimming preparations;
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 |
|---|---|---|
| whole wheat bread yeast basis | Other | Home whole wheat bread yeast basis, TNO whole wheat bread yeast basis |
| Oatmeal | Other | Home Oatmeal, TNO Oatmeal |
| Cheerios | Other | Home original Cheerios, TNO original Cheerios |
| whole wheat sourdough bread | Other | Home whole wheat sourdough bread, TNO whole wheat sourdough bread |
| standard breakfast | Other | Home standard breakfast, TNO standard breakfast |
Primary outcome
Hunger and satiety feelings for different compositions of breakfasts
Time frame: four hours
Response in hunger and satiety feelings due to breakfast consumption over time (four hours) will be measured with a visual analogue rating scale varying of no hunger (0 mm) to very hungry (100 mm)
2 secondary outcomes
Level of control of the conduct (controlled at TNO versus less control at home)
Time frame: Four hour follow-up on hunger and satiety feelings after each breakfast session
Blood glucose
Time frame: two hours
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 19 Oct 2016.
- Background: PubMed 20122136Blundell J, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. Appetite control: methodological aspects of the evaluation of foods. Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29.
- Results publication: PubMed 7794869Raben A, Tagliabue A, Astrup A. The reproducibility of subjective appetite scores. Br J Nutr. 1995 Apr;73(4):517-30. doi: 10.1079/bjn19950056.
- Results publication: PubMed 12833109Pasman WJ, Blokdijk VM, Bertina FM, Hopman WP, Hendriks HF. Effect of two breakfasts, different in carbohydrate composition, on hunger and satiety and mood in healthy men. Int J Obes Relat Metab Disord. 2003 Jun;27(6):663-8. doi: 10.1038/sj.ijo.0802284.
- Results publication: PubMed 22844645Marschollek M, Gietzelt M, Schulze M, Kohlmann M, Song B, Wolf KH. Wearable sensors in healthcare and sensor-enhanced health information systems: all our tomorrows? Healthc Inform Res. 2012 Jun;18(2):97-104. doi: 10.4258/hir.2012.18.2.97. Epub 2012 Jun 30.
- Prevalence of obesityLink provided by the sponsor.
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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.
Wilrike J Pasman, PhD principal investigator
TNO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing whole wheat bread yeast basis, Oatmeal and Cheerios in people with Obesity, run by TNO at 1 site in Netherlands.
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 11 inclusion and 12 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 19 Oct 2016. 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 Netherlands. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Hunger and satiety feelings for different compositions of breakfasts (time frame: four hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02575131, which also lists 4 linked publications.
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 19 Oct 2016.