Subjective Social Status and Energy Balance

NCT03510364 | Completed

• 1 other identifier: IRB2016-571
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigators examined the associations between SSS, energy balance, food intake and changes in body composition following a high calorie lunch for 2 weeks.

Conditions

Obesity; Social Dominance; Social Behavior; Eating Behavior

Keywords

Subjective social status; Obesity; High calorie intake; Energy balance; Eating behavior

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Average of six time points ( Days 1, 2, 7, 8, 12 and 13) over a two week period

• Post-lunch energy intake

  Average of six time points (Days 1, 2, 7, 8, 12 and 13) over a two week period

• Percent changes in body fat

  % change from baseline (day 0) to the end of the intervention period (day 14)

• Percent changes in body weight

  % change from baseline (day 0) to the end of the intervention period (day 14)

• Changes in adjusted resting energy expenditure

  change from baseline (day 0) to the end of the intervention period (day 14)

Study Arms (1)

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.

Behavioral: Dietary intervention

Interventions

Dietary intervention BEHAVIORAL

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.

Dietary intervention

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• between 20-50 years
• body mass index between 25- 30 kg/m2

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Texas Tech University: lead
• Pennington Biomedical Research Center: collaborator
• University of Florida: collaborator
• University of Alabama at Birmingham: collaborator
• Indiana University: collaborator

MeSH Terms

Conditions

Obesity; Social Dominance; Social Behavior; Feeding Behavior

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to the actual study aim. They were told that the aim of the study is to study the relationship between consumption of dietary macronutrient ratios and metabolic rate.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A prospective feeding study with convenience sampling

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: April 27, 2018
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share