Eating BehaviourNCT01680315
Calorie Anticipation and Food Intake
A study testing low calorie yogurt and high calorie yogurt in people with Eating Behaviour and Obesity, run by Uppsala University at 1 site in Sweden.
Trial summary
The regulation of our food intake is on the short-term guided by appetite and satiety signals generated by the sight and consumption of food. Food intake is not only regulated by appetite and satiety signals - external cues also play an important role. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Behaviour, Obesity
- What is being tested?
- low calorie yogurt and high calorie yogurt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- May 2012to Aug 2012
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female
- healthy
- being used to eat breakfast regularly (≥ 5 times a week).
Who cannot join
- hypersensitivity for the ingredients of the foods under study;
- lack of appetite; following an energy-restricted diet or change in body weight > 5 kg; or
- being a vegan or vegetarian. Participants reported not using products that are artificially sweetened, nor sugar in coffee and/or tea.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Physiological Responses of Satiety and Reward After (in)Consistent Calorie Cues.
The regulation of our food intake is on the short-term guided by appetite and satiety signals generated by the sight and consumption of food. Food intake is not only regulated by appetite and satiety signals - external cues also play an important role.
It has been observed that food intake and the pleasure derived from consumption is affected by manipulation of the external cues.
The investigators will assess the contribution of food anticipation (calorie information) and actual consumption of a test food (calorie intake) on in satiety responses (such as ghrelin responses, appetite and subsequent food intake). The investigators expect the information on the amount of calories, rather than the actual amount of calories in the food, to predict the ghrelin responses and the subsequent intake of a second meal.
Read the detailed description
In a randomized cross-over design with 4 conditions, all participants will consume twice the low-caloric food (once with the low-calorie information and once with the high-calorie information) and twice the high-caloric food (again, once with the low-calorie information and once with the high-calorie information) in a randomized order.
- Conditions
- Eating Behaviour, Obesity
- Being tested
- low calorie yogurt, high calorie yogurt
- Keywords
- Satiety,, satiation,, anticipation,, food intake
- Medical subject headings
- Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low calorie yogurtBehavioural
all participants consumed twice the low-caloric food (once with the low-calorie information and once with the high-calorie information)
high calorie yogurtBehavioural
all participants consumed twice the high-caloric food (once with the low-calorie information and once with the high-calorie information)
| Study group | Role | What they receive |
|---|---|---|
| Calorie information | Experimental | Low calorie yogurt
High calorie yogurt
with low calorie information sheet Receives: Behavioral: low calorie yogurt; Behavioral: high calorie yogurt |
| Calorie information (high) | Experimental | Low calorie yogurt
High calorie yogurt
High calorie information sheet Receives: Behavioral: low calorie yogurt; Behavioral: high calorie yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Measured: 60 min (Ad libitum test meal after 1 hr)
Secondary outcomes (1)
Serum concentrations total ghrelin
Measured: 60 min (4 samples - every 20 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviourStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pleunie Hogenkamp, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680315
- Sponsor's protocol ID
- PH2012
- Status last verified
- Aug 2012
- First submitted
- 28 Aug 2012
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hogenkamp PS, Cedernaes J, Chapman CD, Vogel H, Hjorth OC, Zarei S, Lundberg LS, Brooks SJ, Dickson SL, Benedict C, Schioth HB. Calorie anticipation alters food intake after low-caloric not high-caloric preloads. Obesity (Silver Spring). 2013 Aug;21(8):1548-53. doi: 10.1002/oby.20293. Epub 2013 Apr 13.
PubMed 23585292
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Physiological Responses of Satiety and Reward After (in)Consistent Calorie Cues.
- ClinicalTrials.gov ID
- NCT01680315
- Acronym / sponsor ID
- PH2012
- Conditions
- Eating Behaviour, Obesity
- Keywords
- Satiety,, satiation,, anticipation,, food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Sep 2012 (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.
The regulation of our food intake is on the short-term guided by appetite and satiety signals generated by the sight and consumption of food. Food intake is not only regulated by appetite and satiety signals - external cues also play an important role.
It has been observed that food intake and the pleasure derived from consumption is affected by manipulation of the external cues.
The investigators will assess the contribution of food anticipation (calorie information) and actual consumption of a test food (calorie intake) on in satiety responses (such as ghrelin responses, appetite and subsequent food intake). The investigators expect the information on the amount of calories, rather than the actual amount of calories in the food, to predict the ghrelin responses and the subsequent intake of a second meal.
Detailed description
In a randomized cross-over design with 4 conditions, all participants will consume twice the low-caloric food (once with the low-calorie information and once with the high-calorie information) and twice the high-caloric food (again, once with the low-calorie information and once with the high-calorie information) in a randomized order.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calorie information | Experimental | Behavioral: low calorie yogurt, Behavioral: high calorie yogurtLow calorie yogurt High calorie yogurt with low calorie information sheet |
| Calorie information (high) | Experimental | Behavioral: low calorie yogurt, Behavioral: high calorie yogurtLow calorie yogurt High calorie yogurt High calorie information sheet |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female
- healthy
- being used to eat breakfast regularly (≥ 5 times a week).
Key exclusion criteria (3 listed)
- hypersensitivity for the ingredients of the foods under study;
- lack of appetite; following an energy-restricted diet or change in body weight > 5 kg; or
- being a vegan or vegetarian. Participants reported not using products that are artificially sweetened, nor sugar in coffee and/or tea.
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 |
|---|---|---|
| low calorie yogurtall participants consumed twice the low-caloric food (once with the low-calorie information and once with the high-calorie information) | Behavioural | Calorie information, Calorie information (high) |
| high calorie yogurtall participants consumed twice the high-caloric food (once with the low-calorie information and once with the high-calorie information) | Behavioural | Calorie information, Calorie information (high) |
Primary outcome
Food intake
Time frame: 60 min (Ad libitum test meal after 1 hr)
1 secondary outcome
Serum concentrations total ghrelin
Time frame: 60 min (4 samples - every 20 min)
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 7 Sep 2012.
- Derived from this study: PubMed 23585292Hogenkamp PS, Cedernaes J, Chapman CD, Vogel H, Hjorth OC, Zarei S, Lundberg LS, Brooks SJ, Dickson SL, Benedict C, Schioth HB. Calorie anticipation alters food intake after low-caloric not high-caloric preloads. Obesity (Silver Spring). 2013 Aug;21(8):1548-53. doi: 10.1002/oby.20293. Epub 2013 Apr 13.
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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.
Pleunie Hogenkamp, PhD principal investigator
Uppsala 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 low calorie yogurt and high calorie yogurt in people with Eating Behaviour and Obesity, run by Uppsala University at 1 site in Sweden.
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 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 7 Sep 2012. 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 Sweden. 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?
Food intake (time frame: 60 min (Ad libitum test meal after 1 hr)). 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 NCT01680315, which also lists 1 linked publication.
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 7 Sep 2012.