Normal Body WeightNCT02994420
Endocrine and Neural Control of Eating in Women
An observational study of Normal Body Weight and Obesity, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to better understand how female sex hormones influence the food intake in the gut system through the release of satiety hormones as well as through central regulative mechanisms in the brain that subsequently contribute to the control of eating in healthy women at different stages of the… 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
- Normal Body Weight, Obesity
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2016to Dec 2019
- Phase
- Observational
- 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
Study population: Normal-weight and obese women with regular menstrual cycles.
Who may be able to join
- Physically and psychiatrically healthy women
- Stable body weight (no changes ≥ 5 kg in past year)
- Age 18-35 years
- Regular menses (26-32 d cycles)
- Right-handed
- German language fluency
- Signed informed consent
Who cannot join
- Life history of eating disorders
- Aversion to the test foods
- Pacemaker or neurostimulator
- Hearing aid
- Surgery to head or heart
- Potential metal parts in body (pacemakers, metal splinters, gun wounds, shrapnel or surgical clips)
Show all 16Show fewer
- Neurological or psychiatric problems or serious brain injury (such as alcohol or drug abuse, depression, schizophrenia, bipolar disorders, anxiety disorder, claustrophobia, Parkinson's disease, multiple sclerosis, epilepsy)
- High blood pressure, low blood pressure, history of heart disease, irregular heart rate
- Emphysema, chest or respiratory problems (including difficulty breathing through the nose)
- Pregnancy, nursing or pregnancy planned in next three months
- History of gall bladder disease or symptoms (right upper abdominal quadrant pain after meals)
- Polycystic ovary syndrome, as gauged by testosterone levels
- Allergy or sensitivity to lactose
- Allergy to quinine
- Current or previous malignancies
- History of difficult blood sampling
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Reproductive Endocrinology, University Hospital Zurich
Zurich, 8091
About this study
Official title: Steroid Hormones in the Peripheral and Central Control of Eating in Women - Physiological Reactions to Eating in Normal- and Overweight Women
The purpose of this study is to better understand how female sex hormones influence the food intake in the gut system through the release of satiety hormones as well as through central regulative mechanisms in the brain that subsequently contribute to the control of eating in healthy women at different stages of the ovarian cycle.
Read the detailed description
Obesity and the associated severe consequences for health, i.e. cardiovascular diseases or Diabetes Type 2 reach the world-wide level of an epidemic with excessive eating as major cause of this development. Study results of veterinary physiology as well as in women let assume that steroid hormones, such as estrogen or progesterone are highly involved in the regulation of eating behavior and the female body weight. This connection is underpinned with the fact that prevalence of adiposity is increased in women in comparison to men in the United States, Switzerland and further countries. A better understanding of the underlying regulatory mechanisms, which in turn influence the food intake in the gut system through the release of satiety hormones as well as through central regulative mechanisms in the brain, provides important foundation in long-term development of new prophylactic and therapeutic options in reduction and prevention of obesity. This gets even more important, as current therapeutic options - beside bariatric surgery - could only show limited success.
Satiety is a process in the brain that leads to a meal being ended, whereby the ingested food causes a reflexive negative feedback mechanism. This mechanism is both fundamentally and specifically in the acute situation strongly influenced through subjective parameters, e.g. eating desires, socio-cultural factors, current social circumstances and individual relation towards eating. Furthermore, food intake is also influenced by genetic factors, whereas e.g. TaqIA1 allele is known to be associated with obesity. According to current knowledge, regulation takes place on peripheral as well as on central level, whereas not only steroid hormones but also satiety hormones - especially cholecystokinin (CCK) and glucagon-like peptide-1 (GLP-1) - are involved on both levels.
The current study aims to examine the connection of steroid hormones, gastrointestinal satiety hormones and neuronal activity in the brain through fMRI. Through the obtained data, the interaction between defined hormone constellations, gastrointestinal satiety hormones and the activation of specific brain areas in obese and normal-weight women should be evaluated. The study design involves the comparison of subjective, hedonic evaluation of different flavoured liquids with different caloric content each through a rating scale as well as objective peripheral (release of CCK and GLP-1) and central (activation of involved brain centres through fMRI) regulation processes in fasted and fed condition of each woman in the two study groups (obese and normal-weighted) in late follicular compared with the luteal phase of ovarian cycle.
- Conditions
- Normal Body Weight, Obesity
- Keywords
- Obesity, Menstrual Cycle, Gonadal Steroid Hormones, Satiety Response, Glucagon-Like Peptide 1, Cholecystokinin, Magnetic Resonance Imaging
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lean women | BMI 18-25, weight in kg / height in m2 | |
| Obese women | BMI 30-35, weight in kg / height in m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI responses to food cues
Change in blood oxygen dependent signal (BOLD) in exposure to visual food cues will be measured during a fMRI scan and the difference between responses in the fed condition compared with those in the fasted condition
Measured: 90 min per study day
Change in CCK (satiety hormone) response curve
Blood samples will be collected at 0, 5, 10, 15, 20, 25, 30 min following the ingestion of the meal at each experimental visit, giving a specific curve and analyzed to determine the gut hormone responses. The results will be compared between fast and fed condition, between obese and normal weight women and depending on ovarian cycle phase.
Measured: 30 min per study day
Change in GLP-1 (satiety hormone) response curve
Blood samples will be collected at 0, 5, 10, 15, 20, 25, 30 min following the ingestion of the meal at each experimental visit, giving a specific curve and analyzed to determine the gut hormone responses. The results will be compared between fast and fed condition, between obese and normal weight women and depending on ovarian cycle phase.
Measured: 30 min per study day
Secondary outcomes (5)
Change in food preference indicating motivation to purchase food items
The willingness-to-pay task measures the motivation to obtain food on a gLMS scale. The results will be compared between fast and fed condition, between obese and normal weight women and depending on ovarian cycle phase.
Measured: 20 min per study day
Change in food preference indicating motivation to exert effort
The willingness-to-exert-effort task measures the motivation to obtain food on a gLMS scale. The results will be compared between fast and fed condition, between obese and normal weight women and depending on ovarian cycle phase.
Measured: 20 min per study day
Dietary intake
Measure of the calorie intake
Measured: 30 min per study day
Hedonic ratings
Subjective ratings of flavor pleasantness will be collected using psychophysical rating scales (gLMS)
Measured: 20 min per study day
Subjective sensory ratings
Subjective ratings of hunger sensation will be collected using psychophysical rating scales (gLMS)
Measured: 20 min per study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Body WeightStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- Brigitte Leeners, MD, Principal investigator, Clinic for Reproductive Endocrinology, University Hospital ZurichLoredana Asarian, Phd, Study chair, Institute of Veterinary Physiology, Universirty of ZurichPhilippe Tobler, Prof, Study chair, Department of Economics, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994420
- Sponsor's protocol ID
- 2015-0525
- Status last verified
- Sep 2022
- First submitted
- 11 Aug 2016
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroid Hormones in the Peripheral and Central Control of Eating in Women - Physiological Reactions to Eating in Normal- and Overweight Women
- ClinicalTrials.gov ID
- NCT02994420
- Acronym / sponsor ID
- 2015-0525
- Conditions
- Normal Body Weight, Obesity
- Keywords
- Obesity, Menstrual Cycle, Gonadal Steroid Hormones, Satiety Response, Glucagon-Like Peptide 1, Cholecystokinin, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- Jul 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 15 Dec 2016 (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 purpose of this study is to better understand how female sex hormones influence the food intake in the gut system through the release of satiety hormones as well as through central regulative mechanisms in the brain that subsequently contribute to the control of eating in healthy women at different stages of the ovarian cycle.
Detailed description
Obesity and the associated severe consequences for health, i.e. cardiovascular diseases or Diabetes Type 2 reach the world-wide level of an epidemic with excessive eating as major cause of this development. Study results of veterinary physiology as well as in women let assume that steroid hormones, such as estrogen or progesterone are highly involved in the regulation of eating behavior and the female body weight. This connection is underpinned with the fact that prevalence of adiposity is increased in women in comparison to men in the United States, Switzerland and further countries. A better understanding of the underlying regulatory mechanisms, which in turn influence the food intake in the gut system through the release of satiety hormones as well as through central regulative mechanisms in the brain, provides important foundation in long-term development of new prophylactic and therapeutic options in reduction and prevention of obesity. This gets even more important, as current therapeutic options - beside bariatric surgery - could only show limited success.
Satiety is a process in the brain that leads to a meal being ended, whereby the ingested food causes a reflexive negative feedback mechanism. This mechanism is both fundamentally and specifically in the acute situation strongly influenced through subjective parameters, e.g. eating desires, socio-cultural factors, current social circumstances and individual relation towards eating. Furthermore, food intake is also influenced by genetic factors, whereas e.g. TaqIA1 allele is known to be associated with obesity. According to current knowledge, regulation takes place on peripheral as well as on central level, whereas not only steroid hormones but also satiety hormones - especially cholecystokinin (CCK) and glucagon-like peptide-1 (GLP-1) - are involved on both levels.
The current study aims to examine the connection of steroid hormones, gastrointestinal satiety hormones and neuronal activity in the brain through fMRI. Through the obtained data, the interaction between defined hormone constellations, gastrointestinal satiety hormones and the activation of specific brain areas in obese and normal-weight women should be evaluated. The study design involves the comparison of subjective, hedonic evaluation of different flavoured liquids with different caloric content each through a rating scale as well as objective peripheral (release of CCK and GLP-1) and central (activation of involved brain centres through fMRI) regulation processes in fasted and fed condition of each woman in the two study groups (obese and normal-weighted) in late follicular compared with the luteal phase of ovarian cycle.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean women | – | –BMI 18-25, weight in kg / height in m2 |
| Obese women | – | –BMI 30-35, weight in kg / height in m2 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Normal-weight and obese women with regular menstrual cycles.
Key inclusion criteria (7 listed)
- Physically and psychiatrically healthy women
- Stable body weight (no changes ≥ 5 kg in past year)
- Age 18-35 years
- Regular menses (26-32 d cycles)
- Right-handed
Key exclusion criteria (16 listed)
- Life history of eating disorders
- Aversion to the test foods
- Pacemaker or neurostimulator
- Hearing aid
- Surgery to head or heart
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fMRI responses to food cues
Time frame: 90 min per study day
Change in blood oxygen dependent signal (BOLD) in exposure to visual food cues will be measured during a fMRI scan and the difference between responses in the fed condition compared with those in the fasted condition
Change in CCK (satiety hormone) response curve
Time frame: 30 min per study day
Blood samples will be collected at 0, 5, 10, 15, 20, 25, 30 min following the ingestion of the meal at each experimental visit, giving a specific curve and analyzed to determine the gut hormone responses. The results will be compared between fast and fed condition, between obese and normal weight women and depending on ovarian cycle phase.
Change in GLP-1 (satiety hormone) response curve
Time frame: 30 min per study day
Blood samples will be collected at 0, 5, 10, 15, 20, 25, 30 min following the ingestion of the meal at each experimental visit, giving a specific curve and analyzed to determine the gut hormone responses. The results will be compared between fast and fed condition, between obese and normal weight women and depending on ovarian cycle phase.
5 secondary outcomes
Change in food preference indicating motivation to purchase food items
Time frame: 20 min per study day
Change in food preference indicating motivation to exert effort
Time frame: 20 min per study day
Dietary intake
Time frame: 30 min per study day
Hedonic ratings
Time frame: 20 min per study day
Subjective sensory ratings
Time frame: 20 min per study day
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 2022.
- 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.
Brigitte Leeners, MD principal investigator
Clinic for Reproductive Endocrinology, University Hospital Zurich
Loredana Asarian, Phd study chair
Institute of Veterinary Physiology, Universirty of Zurich
Philippe Tobler, Prof study chair
Department of Economics, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Body Weight and Obesity, run by University of Zurich at 1 site in Switzerland.
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 7 inclusion and 16 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 2022. 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 Switzerland. 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?
fMRI responses to food cues (time frame: 90 min per study day). 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 28 Sep 2022.