Obesity, Overweight
Conditions
Brief summary
Effective nutrition strategies for combatting and/or preventing obesity still need to be identified. This has been the case despite the numerous and different approaches that have been taken. Potential targets for combatting/preventing obesity have been identified, but long-term solutions have not emerged. This study uses time restricted feeding to study the role of dietary protein in obesity prevention and/or treatment. The objectives are to determine the role of skeletal muscle mass as a driver of energy-sensing mechanisms and peripheral signals that regulate appetite and energy intake in overweight and obese adults and to determine the effects of protein timing on muscle mass to regulate appetite and energy intake in overweight and obese adults.
Interventions
DIETARY_SUPPLEMENTKetogenic aid
Participants consume ketogenic aid upon waking.
OTHERControl group - time restricted feeding only
Time restricted feeding.
DIETARY_SUPPLEMENTWhey protein supplement
Participants consume whey protein at the beginning of the eating period.
Sponsors
University of Arkansas, Fayetteville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Resides in Northwest Arkansas * Age 25-50 years * BMI \> 25 * All ethnicities * Female and male
Exclusion criteria
* Food allergies * Pregnant or breastfeeding * Dietary restrictions (e.g. vegetarian, vegan, etc.) * Trying to lose weight in last 3 months * Pre-existing health conditions related to obesity (e.g. cardiovascular disease, diabetes, hypertension) * Prescription medications related to heart disease or type 2 diabetes * Fear of needles * Smoker or vaping * Currently taking protein supplements or other nutritional supplements which may interfere with study outcomes * Consumes \>4 alcoholic beverages per week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | Change is being assessed at baseline and final day (day 120) of the intervention. | Body composition measured using dual x-ray absorptiometry to determine the ration of lean/fat-free mass to fat mass. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle mass | Change is being assessed at baseline and final day (day 120) of the intervention. | Muscle mass will be measured using D3-creatine |
| Body weight | Change is being assessed at baseline, 4, 8, and 12 weeks. | Body weight will be measured in kilograms. |
| Sleep | Change is being assessed at baseline and 12 weeks | Sleep will be assessed using wrist Actigraphy for sleep duration and total time in bed. |
| Sleep Quality | Change is being assessed at baseline, 4, 8, and 12 weeks | Sleep quality will be measured using the Pittsburgh Sleep Quality Index survey |
| Mood | Change is being assessed at baseline, 4, 8, and 12 weeks | Mood will be assessed using the Profile of Mood States Questionnaire |
| Whole body protein turnover | Change is being assessed at baseline and final day (day 120) of the intervention. | Whole body protein turnover will be measured using 15N-alanine |
| Self-reported physical activity | Change is being assessed at baseline, 4, 8, and 12 weeks | Physical activity will be measured using the iPAQ survey |
| Dietary intake | Change is being assessed at baseline, 4, 8, and 12 weeks | Dietary intake will be measured using weighed, 3-day food records |
| Fasting glucose | Change is being assessed at baseline, 4, 8, and 12 weeks | Glucose will be measured as mg/dl |
| Hand grip | Change is being assessed at baseline, 4, 8, and 12 weeks | Hand grip will be measured using a dynamometer. |
| Amino acids and metabolites | Change is being assessed at baseline, 4, 8, and 12 weeks | Blood will be collected and plasma amino acids and metabolites will be assessed using commercially available kit for amino acid analysis for all circulating amino acids. |
| Grit | Change is being assessed at baseline, 4, 8, and 12 weeks | Grit will be assessed using the grit questionnaire. |
Countries
United States
Contacts
Primary ContactJamie Baum, PhD
Outcome results
None listed