Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000319471
Ethics application status
Approved
Date submitted
9/06/2015
Date registered
10/03/2016
Date last updated
10/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to investigate the relationship between stress and weight
Scientific title
Stress and weight: a study to investigate the relationship between stress and weight in healthy and obese humans
Secondary ID [1] 286846 0
Nil known
Universal Trial Number (UTN)
U1111-1170-9108
Trial acronym
SWS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 295239 0
Condition category
Condition code
Metabolic and Endocrine 295484 295484 0 0
Metabolic disorders
Diet and Nutrition 295613 295613 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will investigate the relationship between weight and stress (cortisol metabolism). Specifically, in healthy and obese men and women we will firstly determine the optimum conditions for measuring cortisol, and compare and contrast differences between collection methods (ie. saliva, fasting blood and 24h urine). We will also obtain subcutaneous adipose tissue and skeletal muscle biopsies to study cortisol metabolism in target tissues, and link these with differences in resting metabolic rate, body composition, stress, anxiety and depression and sleep quality, physical activity levels and previous weight history. We will also assess reproducibility between samples taken from each participant. The duration of the study will be three weeks. We will collect samples/ take each measurement up to three times during this period.
Intervention code [1] 292010 0
Not applicable
Comparator / control treatment
Healthy lean controls
Control group
Active

Outcomes
Primary outcome [1] 295220 0
Correlation of the salivary cortisol levels circulating levels.with body weight

Cortisol levels in lean and obese
Cortisol will be measured in saliva using swab method (SalivaBio Oral Swab) and assayed by ELISA (Salimetrics). Circulating cortisol will be measured in plasma and 24h urinary cortisol in urine collected over 24h period using ELISA (AbCam).



Timepoint [1] 295220 0
weeks 1&2
Parameters will be measured multiple times per week for a total duration of two weeks.
Primary outcome [2] 295329 0
Correlation of body weight with intracellular cortisol activity in target tissues.

Body weight will be determined using calibrated scales; body composition will be determined by BodPod (air displacement plethysmography); anthropometry (waist and hip circumference; height by stretch stature) Tissue biopsies (subcutaneous adipose tissue and skeletal muscle) will be obtained using bergstrum needle with modified suction and will be performed by a medical doctor with expertise in performing tissue biopsies. Intracellular activation and downstream cortisol signaling/ metabolism in collected biopsy samples will be investigated using standard molecular biology techniques (western blotting, ELISA, RTqPCR etc).
Timepoint [2] 295329 0
week 3
Primary outcome [3] 295330 0
Correlation of the cortisol levels (salivary, circulating, 24h urine) with resting metabolic rate.

Resting metabolic rate will be determined by indirect calorimetry (Parvomedics) in overnight fasted participants.
Timepoint [3] 295330 0
weeks 1 & 2
Secondary outcome [1] 315103 0
Correlation of tissue-specific intracellular activation of cortisol with perceived stress

Stress will be assessed by DASS42 questionaire
Timepoint [1] 315103 0
Weeks 1-3
Parameters will be measured per week for a total duration of two weeks. In week 3 participants will be given the option to have tissue biopsies taken for investigation of tissue-specific metabolism. DASS42 will be performed per week for 3 weeks
Secondary outcome [2] 315364 0
Correlation of tissue-specific intracellular activation of cortisol with sleep quality

Sleep quality will be assessed using the Pittsburgh sleep diary over 14days. Intracellular activation of cortisol will be assessed in tissue biopsies (subcutaneous adipose tissue and skeletal muscle) obtained using bergstrum needle with modified suction. Intracellular activation and downstream cortisol signaling/ metabolism in collected biopsy samples will be investigated using standard molecular biology techniques (enzymatic assays, HPLC/ LC-MS, western blotting, ELISA, RTqPCR etc).
Timepoint [2] 315364 0
Weeks 1&2
Secondary outcome [3] 315365 0
Correlation of tissue-specific intracellular activation of cortisol with physical activity levels

Walking economy and physical activity levels will be determined by performing walking test on a treadmill connected to metabolic cart (Parvomedics; indirect calorimetry) and participants wearing an accelerometer on their wrist for 7 days. Intracellular activation of cortisol will be assessed in tissue biopsies (subcutaneous adipose tissue and skeletal muscle) obtained using bergstrum needle with modified suction. Intracellular activation and downstream cortisol signaling/ metabolism in collected biopsy samples will be investigated using standard molecular biology techniques (enzymatic assays, HPLC/ LC-MS, western blotting, ELISA, RTqPCR etc).
Timepoint [3] 315365 0
Weeks 1-3

Exercise test will be performed per week for 2 weeks. Physical activity levels will be determined for 7 days in week 1 and repeated in week 2. Tissue biopsies will be performed in week3

Eligibility
Key inclusion criteria
Participants may be included in the study if they are an adult (over the age of 18) and are Sedentary (< 60 min of physical activity per week), either class I or II obese (30-40 +/- 2 kg.m-2) and have a waist circumference >88 cm if female or >102cm if male or lean healthy (18.5-24.9 kg.m-2 and have a waist circumference <88 cm if female or <102cm if male; weight stable (i.e. have not gained or lost more than 2 kg in the previous 6 months), of Caucasian ancestry and with no medical conditions or medications that will impact on their hormonal profile, cortisol metabolism or metabolic rate (e.g. Insulin Dependent Diabetes Mellitus (IDDM), Non-Insulin Dependent Diabetes Mellitus (NIDDM), Hypertension, Hypercholesterolemia, Arthritis, Coronary Heart Disease, and musculoskeletal problems, Cushings Syndrome, anxiety, depression or known psychological mood disorders, high dose oestrogen contraceptive pill ), and if female pre-menopausal and have a regular menstrual cycle of 26 – 30 days.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not an adult (under 18 years); pregnant; existing in a dependent relationship due to disability; highly dependent on medical care; Aboriginal and/or Torres Straight Islander; involved in illegal activity.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Data will be expressed as means +/- standard error of the mean (SEM). Results will be analysed using Student’s t test, paired t test or analysis of variance (ANOVA) procedures where appropriate using GraphPad Prism software. Power is set to 80% and significance was accepted at P< 0.05.

Based on power calculations (Salivary cortisol Mean for Obese Women: 0.75 +/- 0.1, and Mean for Lean Women: 0.85 +/- 0.1; Mean for Obese Men: 0.85 +/-0.02, and Mean for Lean Men: 0.75 +/- 0.02) and clinical and experimental observation from pilot testing and experience the following participants will be required (N=22/group for Women and N=13/group for men) to achieve statistical significance between lean and obese subjects and assess reproducibility (inter and intra samples variation) for the parameters measured (in particular cortisol levels, tissue specific metabolism, resting metabolic rate, which are the primary and secondary outcomes of the study).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
31/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 9758 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 291402 0
University
Name [1] 291402 0
Bond UniversityVCR seeding grant
Country [1] 291402 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Drive, Robina, QLD 4226
Country
Australia
Secondary sponsor category [1] 290077 0
None
Name [1] 290077 0
None
Address [1] 290077 0
Country [1] 290077 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292950 0
Bond University Human Research Committee
Ethics committee address [1] 292950 0
Ethics committee country [1] 292950 0
Australia
Date submitted for ethics approval [1] 292950 0
06/04/2015
Approval date [1] 292950 0
02/06/2015
Ethics approval number [1] 292950 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57774 0
Dr Hayley O'Neill
Address 57774 0
Bond University
Bond Institute of Health and Sport
Faculty of Health Science and Medicine
2 Promethean Way
Robina QLD, 4226
Country 57774 0
Australia
Phone 57774 0
+61 7 55953539
Fax 57774 0
Email 57774 0
[email protected]
Contact person for public queries
Name 57775 0
Hayley O'Neill
Address 57775 0
Bond University
Bond Institute of Health and Sport
Faculty of Health Science and Medicine
2 Promethean Way
Robina QLD, 4226
Country 57775 0
Australia
Phone 57775 0
+61 7 55953539
Fax 57775 0
Email 57775 0
[email protected]
Contact person for scientific queries
Name 57776 0
Hayley O'Neill
Address 57776 0
Bond University
Bond Institute of Health and Sport
Faculty of Health Science and Medicine
2 Promethean Way
Robina QLD, 4226
Country 57776 0
Australia
Phone 57776 0
+61 7 55953539
Fax 57776 0
Email 57776 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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