Stress and Eating Behavior Among University Students - an Randomized Controlled Trial

NCT02708979 | Unknown

• 1 other identifier: B321
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The high worldwide prevalence of overweight and obesity as well as metabolic and disease consequences, are well-documented. The positive energy balance underlying obesity is attributable to excess energy intake and/or insufficient energy expenditure. However, it seems that the increase in mean body weight can be sufficiently explained by increases in mean energy intake. It has been proposed that this overeating is partly caused by increased availability of highly processed energy dense, high reward foods. Psychosocial stress and sleep insufficiency is pervasive in industrialized societies. A growing body of evidence suggests stress to be involved in obesity, although it is unknown whether stress is a cause or consequence. Stress affecting dietary intake; skewing intake towards greater consumption of highly palatable energy dense foods, also referred to as high reward foods. A causal relationship between stress and reward seeking behavior is supported by findings from animal studies reporting rewarding behavior by consumption of sweet tasting food in response to a stressor. Our aim is to investigate differences in purchases of particular food-items in free living individuals, during a stressful (upcoming exam) and non-stressful (no upcoming exam) period. Hypothesis: Participants will purchase more high reward foods during the pre-exam period, compared to the control non-exam period.

Conditions

Stress

Keywords

Stress; Eating

Outcome Measures

Primary Outcomes (1)

• Differences in purchase of high reward foods from the gift certificates between the exam-period and non-exam period.

  The classification will be done blinded for the outcome assessor.

  The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)

Secondary Outcomes (10)

• Differences in Heart Rate Variability (HRV) based on a one minute breathing test between the exam-period and non-exam period.

  The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)

• Differences in morning cortisol measured in saliva between the exam-period and non-exam period.

  The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)

• Differences in insulin resistance measured by homeostatic model assessment (HOMA-IR) calculated from insulin and glucose measured in plasma between the exam-period and non-exam period.

  The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)

• Differences in Perceived Stress (Perceived Stress Scale, PSS) between the exam-period and non-exam period.

  The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)

• Differences in eating behavior using the "Three factor eating questionnaire" between the exam-period and non-exam period.

  The outcome is assessed twice, once in the exam period (one week prior to an exam) and once in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016)

Study Arms (2)

University Exam Period

ACTIVE COMPARATOR

This visit takes place the week before an exam at the university assuming that this will induce a stress response. Measurements (see description elsewhere) are being taken within 1-2 weeks prior to an university exam.

Other: University exam-period

University Non-exam Period

PLACEBO COMPARATOR

This visit takes place several weeks post and prior to an exam at the university assuming that students will not be stressed in this period. Measurements (see description elsewhere) are being taken in a control-period without exams (at least 4 weeks after and 4 weeks prior to an exam)

Other: University non-exam-period

Interventions

University exam-period OTHER

This visit takes place one week prior to an exam at the university assuming that students will be stressed in this period.

University Exam Period

University non-exam-period OTHER

This visit takes place several weeks post and prior to an exam at the university assuming that students will not be stressed in this period.

University Non-exam Period

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, weight stabile (defined as no weight gain/loss \>3 kg during the past three months) students at the University of Copenhagen
• Age \> 18 years, men and women

You may not qualify if:

• Purposefully seeking to lose or gain weight
• Diabetes.
• Blood donation \< 1 week prior to the study and during the study
• Lactation, Pregnancy or planning of pregnancy during the study
• Inability, physically or mentally, to comply with the procedures required by the study- protocol, as evaluated by the investigator
• Participation in other clinical trials during the study
• Diagnosed with stress
• Daily use of medication influencing biomarkers of stress

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Nutrition, Exercise and Sports

Frederiksberg, Frederiksberg, 1958, Denmark

RECRUITING

Study Officials

• Anders M Sjödin, PhD

  University of Copenhagen, NEXS

  STUDY CHAIR

• Mads F Hjorth, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Julie B Schmidt, PhD

  University of Copenhagen, NEXS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mads F Hjorth, PhD

CONTACT

35332489; madsfiil@nexs.ku.dk

Julie B Schmidt, PhD

CONTACT

35333650; jbs@nexs.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 15, 2016
• Study Start: February 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 15, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)