Endocrine and Neural Control of Eating in Women

NCT02994420 | Completed

• 1 other identifier: 2015-0525
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Normal Body Weight; Obesity

Keywords

Obesity; Menstrual Cycle; Gonadal Steroid Hormones; Satiety Response; Glucagon-Like Peptide 1; Cholecystokinin; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Change in food preference indicating motivation to purchase food items

  20 min per study day

• Change in food preference indicating motivation to exert effort

  20 min per study day

• Dietary intake

  30 min per study day

• Hedonic ratings

  20 min per study day

• Subjective sensory ratings

  20 min per study day

Study Arms (2)

Lean women

BMI 18-25, weight in kg / height in m2

Obese women

BMI 30-35, weight in kg / height in m2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Normal-weight and obese women with regular menstrual cycles.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• University Hospital, Zürich: collaborator

Study Sites (1)

Clinic for Reproductive Endocrinology, University Hospital Zurich

Zurich, 8091, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood to determine hormonal parameters (gut hormones and reproductive hormones) and the presence of the gene TaqIA1.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brigitte Leeners, MD

  Clinic for Reproductive Endocrinology, University Hospital Zurich

  PRINCIPAL INVESTIGATOR

• Loredana Asarian, Phd

  Institute of Veterinary Physiology, Universirty of Zurich

  STUDY CHAIR

• Philippe Tobler, Prof

  Department of Economics, University of Zurich

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: December 15, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)