ObesityNCT03510364
Subjective Social Status and Energy Balance
A study testing Dietary intervention in people with Obesity and Social Dominance, run by Texas Tech University.
Trial summary
Investigators examined the associations between SSS, energy balance, food intake and changes in body composition following a high calorie lunch for 2 weeks. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Social Dominance, Social Behavior
- What is being tested?
- Dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- between 20-50 years
- body mass index between 25- 30 kg/m2
Who cannot join
- food allergies or food restrictions
- engaged in any weight reduction program within the past 3 months
- experienced any weight loss or gain of >5% of body weight in the past 6 months for any reason except post-partum weight loss
- taking any medication that suppresses or stimulates appetite
- undergone prior surgical procedures for weight control or liposuction
- current smoker or has not smoked in less than 6 months
Show all 19Show fewer
- any major diseases including active cancer or cancer requiring treatment in the past 2 years (except non-melanoma skin cancer)
- active or chronic infections (e.g., HIV or TB)
- cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease in the past 6 months
- gastrointestinal disease
- kidney disease
- chronic obstructive airway disease requiring use of oxygen (e.g., emphysema or chronic bronchitis)
- diabetes (type 1 or 2) and taking any anti-diabetic medications and/or controlling the disease via dietary manipulations
- uncontrolled psychiatric disease
- a recent or ongoing problem with drug abuse or addiction
- consume more than three alcoholic drinks per day and has had 7 or more alcoholic beverages in a 24 hour period in the last 12 months
- pregnant or less than 3 months post-partum
- currently nursing or within 6 weeks of having completed nursing
- anticipating a possible pregnancy during the study
About this study
Official title: Perceived Social Status as a Determinant of Fat Accretion in Response to Excess Calories: the SSIB Study
Investigators examined the associations between SSS, energy balance, food intake and changes in body composition following a high calorie lunch for 2 weeks.
Read the detailed description
Subjective social status (SSS) is inversely associated with body fatness. The physiological and psychological effects of low social status may spur increased energy intake as a strategy to buffer against future food scarcity. Investigators' central hypothesis is that females with low SSS will not compensate for excess calorie consumption in a single large meal as well as individuals with high SSS, and will therefore remain in positive energy balance leading to body fat gain in response to daily large meals. Investigators' objective is to understand the influence of SSS on eating behavior, weight gain, and energetic compensation. Investigators conducted a 14-day feeding protocol that consisted of consumption of a lunch-time meal that was 60% of participants' estimated 24-hour energy requirements each day in female participants between 20-50 years, with a body mass index between 25- 30 kg/m2. Free-living food intake was recorded using the Remote Food Photography Method outside of the lab on days 1-2 (early), 7-8 (middle), and 12-13 (late), to measure compensation in response to the large lunch. 24-Hour energy balance, 24 hour intake and post-lunch energy intake were calculated for those days. Investigators measured body composition using Dual energy x ray absorptiometry (DXA), weight and resting energy expenditure at the baseline and at the end of the 14 days of the intervention.
- Conditions
- Obesity, Social Dominance, Social Behavior, Eating Behavior
- Being tested
- Dietary intervention
- Keywords
- Subjective social status, Obesity, High calorie intake, Energy balance, Eating behavior
- Medical subject headings
- Obesity, Social Dominance, Social Behavior, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionBehavioural
For the feeding intervention, participants consumed a meal that contains 60% of their energy daily energy requirement as a lunch time meal for 14 consecutive days under observation except during the weekends. To ensure the participant receives 60% of the daily energy requirement as a lunch meal we added a supplemental shake to the standard 1200 kcal meal.
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | All participants consumed a meal that contains 60% of their energy daily energy requirement as a lunch time meal for 14 consecutive days. Receives: Behavioral: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average 24 hour energy balance (24hr EB)
We measured 24-hr energy balance to assess the association of SSS with positive energy balance in response to a daily large meal perturbation. Twenty four hour energy balance was calculated for each time point as follows, and all six time points were averaged to get an average energy balance over the 2-week period:
24 hr Energy balance = Average 24 hr Energy intake / Resting Energy Expenditure *1.4 For the early and middle time point 24EB calculations, baseline resting energy expenditure (REE) was used and for late 24hr EB, final REE obtained at the end of the study was used.
Measured: Six time points ( Days 1, 2, 7, 8, 12 and 13) measured over the two week feeding protocol.
Secondary outcomes (5)
Average 24 hour energy intake (24hr EI) over a two week period
Amount of total calories consumed over 24 hours. - consists of breakfast, morning snack, lunch, afternoon snack, dinner, evening snack within 24 hours.
Measured: Average of six time points ( Days 1, 2, 7, 8, 12 and 13) over a two week period
Post-lunch energy intake
Amount of total calories consumed after lunch - consists of afternoon snack, dinner, evening snack.
Measured: Average of six time points (Days 1, 2, 7, 8, 12 and 13) over a two week period
Percent changes in body fat
Changes in the body fat mass
Measured: % change from baseline (day 0) to the end of the intervention period (day 14)
Percent changes in body weight
Changes in the body weight
Measured: % change from baseline (day 0) to the end of the intervention period (day 14)
Changes in adjusted resting energy expenditure
Resting energy expenditure (REE) was adjusted to the lean mass. the change in adjusted REE = final adjusted REE - baseline adjusted REE
Measured: change from baseline (day 0) to the end of the intervention period (day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective feeding study with convenience sampling
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center, University of Florida, University of Alabama at Birmingham, Indiana University
- Responsible party
- Principal investigator, Emily Dhurandhar, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510364
- Sponsor's protocol ID
- IRB2016-571
- Status last verified
- Apr 2018
- First submitted
- 12 Mar 2018
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Social Status as a Determinant of Fat Accretion in Response to Excess Calories: the SSIB Study
- ClinicalTrials.gov ID
- NCT03510364
- Acronym / sponsor ID
- IRB2016-571
- Conditions
- Obesity, Social Dominance, Social Behavior, Eating Behavior
- Keywords
- Subjective social status, Obesity, High calorie intake, Energy balance, Eating behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center, University of Florida, University of Alabama at Birmingham, Indiana University
- Study start
- Jun 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators examined the associations between SSS, energy balance, food intake and changes in body composition following a high calorie lunch for 2 weeks.
Detailed description
Subjective social status (SSS) is inversely associated with body fatness. The physiological and psychological effects of low social status may spur increased energy intake as a strategy to buffer against future food scarcity. Investigators' central hypothesis is that females with low SSS will not compensate for excess calorie consumption in a single large meal as well as individuals with high SSS, and will therefore remain in positive energy balance leading to body fat gain in response to daily large meals. Investigators' objective is to understand the influence of SSS on eating behavior, weight gain, and energetic compensation. Investigators conducted a 14-day feeding protocol that consisted of consumption of a lunch-time meal that was 60% of participants' estimated 24-hour energy requirements each day in female participants between 20-50 years, with a body mass index between 25- 30 kg/m2. Free-living food intake was recorded using the Remote Food Photography Method outside of the lab on days 1-2 (early), 7-8 (middle), and 12-13 (late), to measure compensation in response to the large lunch. 24-Hour energy balance, 24 hour intake and post-lunch energy intake were calculated for those days. Investigators measured body composition using Dual energy x ray absorptiometry (DXA), weight and resting energy expenditure at the baseline and at the end of the 14 days of the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
- Model description
- A prospective feeding study with convenience sampling
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Behavioral: Dietary interventionAll participants consumed a meal that contains 60% of their energy daily energy requirement as a lunch time meal for 14 consecutive days. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- between 20-50 years
- body mass index between 25- 30 kg/m2
Key exclusion criteria (19 listed)
- food allergies or food restrictions
- engaged in any weight reduction program within the past 3 months
- experienced any weight loss or gain of >5% of body weight in the past 6 months for any reason except post-partum weight loss
- taking any medication that suppresses or stimulates appetite
- undergone prior surgical procedures for weight control or liposuction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary interventionFor the feeding intervention, participants consumed a meal that contains 60% of their energy daily energy requirement as a lunch time meal for 14 consecutive days under observation except during the weekends. To ensure the participant receives 60% of the daily energy requirement as a lunch meal we added a supplemental shake to the standard 1200 kcal meal. | Behavioural | Dietary intervention |
Primary outcome
Average 24 hour energy balance (24hr EB)
Time frame: Six time points ( Days 1, 2, 7, 8, 12 and 13) measured over the two week feeding protocol.
We measured 24-hr energy balance to assess the association of SSS with positive energy balance in response to a daily large meal perturbation. Twenty four hour energy balance was calculated for each time point as follows, and all six time points were averaged to get an average energy balance over the 2-week period: 24 hr Energy balance = Average 24 hr Energy intake / Resting Energy Expenditure *1.4 For the early and middle time point 24EB calculations, baseline resting energy expenditure (REE) was used and for late 24hr EB, final REE obtained at the end of the study was used.
5 secondary outcomes
Average 24 hour energy intake (24hr EI) over a two week period
Time frame: Average of six time points ( Days 1, 2, 7, 8, 12 and 13) over a two week period
Post-lunch energy intake
Time frame: Average of six time points (Days 1, 2, 7, 8, 12 and 13) over a two week period
Percent changes in body fat
Time frame: % change from baseline (day 0) to the end of the intervention period (day 14)
Percent changes in body weight
Time frame: % change from baseline (day 0) to the end of the intervention period (day 14)
Changes in adjusted resting energy expenditure
Time frame: change from baseline (day 0) to the end of the intervention period (day 14)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Obesity and Social Dominance, run by Texas Tech University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average 24 hour energy balance (24hr EB) (time frame: Six time points ( Days 1, 2, 7, 8, 12 and 13) measured over the two week feeding protocol.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.