Endocrine and Neural Control of Eating in Women

Obesity Clinical Trial

Official title:

Steroid Hormones in the Peripheral and Central Control of Eating in Women - Physiological Reactions to Eating in Normal- and Overweight Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994420
• Other study ID #: 2015-0525
• Status: Completed
• Start date: July 2016
• Est. completion date: December 2019

Study information

• Verified date: September 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 ovarian cycle.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• 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

Related Conditions & MeSH terms

• Body Weight
• Normal Body Weight
• Obesity

Locations

Country	Name	City	State
Switzerland	Clinic for Reproductive Endocrinology, University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90 min per study day
Primary	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.	30 min per study day
Primary	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.	30 min per study day
Secondary	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.	20 min per study day
Secondary	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.	20 min per study day
Secondary	Dietary intake	Measure of the calorie intake	30 min per study day
Secondary	Hedonic ratings	Subjective ratings of flavor pleasantness will be collected using psychophysical rating scales (gLMS)	20 min per study day
Secondary	Subjective sensory ratings	Subjective ratings of hunger sensation will be collected using psychophysical rating scales (gLMS)	20 min per study day