Stress Clinical Trial
— StrEatOfficial title:
StrEat - Stress and Eating Behavior
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Denmark | Nutrition, Exercise and Sports | Frederiksberg |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Secondary | Differences in Heart Rate Variability (HRV) based on a one minute breathing test 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) | No |
Secondary | Differences in morning cortisol measured in saliva 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) | No |
Secondary | 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 analyses 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) | No |
Secondary | Differences in Perceived Stress (Perceived Stress Scale, PSS) between the exam-period and non-exam period. | The analyses 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) | No |
Secondary | Differences in eating behavior using the "Three factor eating questionnaire" between the exam-period and non-exam period. | The analyses 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) | No |
Secondary | Differences in sleep habits using the "Pittsburgh sleep quality index" between the exam-period and non-exam period. | The analyses 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) | No |
Secondary | Differences in sleep duration measured by ActiGraph between the exam-period and non-exam period. | The analyses will be done blinded for the outcome assessor. | The outcome is assessed twice, in the exam period (one week prior to an exam) and in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016) | No |
Secondary | Differences in activity measured by ActiGraph between the exam-period and non-exam period. | The analyses will be done blinded for the outcome assessor. | The outcome is assessed twice,in the exam period (one week prior to an exam) and in the non-exam period (four to five weeks prior and post an exam ) Data are analyzed after last subject last visit (May 2016) | No |
Secondary | Differences in blood pressure between the exam-period and non-exam period. | The analyses 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) | No |
Secondary | Differences in Perceived Stress ( questionaire: RESTQ-76 sport) between the exam-period and non-exam period. | The analyses 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) | No |
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