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Completed

NCT Number: NCT02994420

Endocrine and Neural Control of Eating in 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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Clinic for Reproductive Endocrinology, University Hospital Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. Change in food preference indicating motivation to purchase food items

    Time frame: 20 min per study day

    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.

  2. Change in food preference indicating motivation to exert effort

    Time frame: 20 min per study day

    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.

  3. Dietary intake

    Time frame: 30 min per study day

    Measure of the calorie intake

  4. Hedonic ratings

    Time frame: 20 min per study day

    Subjective ratings of flavor pleasantness will be collected using psychophysical rating scales (gLMS)

  5. Subjective sensory ratings

    Time frame: 20 min per study day

    Subjective ratings of hunger sensation will be collected using psychophysical rating scales (gLMS)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • University Hospital, Zürich

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 15, 2016
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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