ObesityugaDIVASNCT01893684
Dietary Intervention and Varying Physical Activity in Seniors
A study testing Exercise, Higher Protein Diet and Conventional Carbohydrate Diet in people with Obesity, run by University of Georgia at 1 site in United States.
Trial summary
The prevalence of obesity continues to increase at an alarming rate for all sectors of the population in the US. Obesity in the older adult cohort is of great concern as it is associated with reductions in mobility, declines in physical performance and increased risk for physical disability. Read more about this study
- Who is it for?
- Ages 65 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise, Higher Protein Diet and Conventional Carbohydrate Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2013to 1 Jul 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 65 to 80 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Female
- Overweight or obese (BMI ≥ 25 kg/m2)
- 65-80 years of age
- English speaking
- Plan to live in the community for the duration of the study (~6 months)
- Weight stable (within 2 kg) for the past 6 months
Show all 14Show fewer
- Sedentary (defined as <1 hr/week of physical activity or less than 2 exercise sessions per week in the last 6 months)
- Free of a history or diagnosis of renal insufficiency or disease
- Willing to obtain physician clearance
- Willing to be randomized to treatment groups
- Free of any chronic disease/condition that would not permit exercise or dietary restriction or alter interpretation of data.
- Willing to meet all study requirements and randomization
- Non-smoking and tobacco using
- Able to obtain transportation to the UGA campus
Who cannot join
- Normal weight (BMI < 25 kg/m2)
- Males
- Dietary restrictions that do not allow for the consumption of beef, as required by our dietary protocol.
- Weight loss surgery and/or weight loss medications usage.
- Any metal within the body and claustrophobia which precludes MRI assessment.
- Mini-mental state exam score < 25
Show all 14Show fewer
- Recent or history of unstable CVD
- Cancer treatment within the last 5 years or active cancer
- History of lung disease or COPD or severe asthma
- Use of anti-inflammatory or steroid medications
- History or severe arthritis or other medical condition that precludes ability to exercise to level needed by study
- Current diagnosis or history of balance disorders
- History of mental disorders, dementia, clinical depression or other disorders that preclude adherence to protocols
- Current weight of 350 pounds of greater, due to weight restrictions on equipment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Higher Protein Weight Loss Diet and Exercise on Body Composition, Physical Function, and Fatigue in Overweight Older Women
The prevalence of obesity continues to increase at an alarming rate for all sectors of the population in the US. Obesity in the older adult cohort is of great concern as it is associated with reductions in mobility, declines in physical performance and increased risk for physical disability. With regard to body composition, a) fat mass has been determined to be a stronger predictor of mobility limitations than low muscle mass in older individuals and alternatively, b) leg lean mass has also been cited as a primary determinant of lower extremity physical function.
Obesity is related to increased levels of fatigue and lack of motivation and mental energy. Fatigue can be categorized as both a subjective perception and a performance decrement. Fatigue can be defined as a perceived lack of physical or mental energy while fatigability is another construct categorized by the degree of fatigue associated with activity in any dimension (i.e. physical, mental, emotional, and/or social).
Read more
The impact of a higher protein diet on muscle quality, muscle fatigability, perceptions of fatigue and systemic inflammation in older adults has not been well documented. The utility of a higher protein weight loss diet combined with resistance exercise training to augment fat mass loss, attenuate lean mass loss and improve muscle quality and physical function could potentially be of high value to overweight older women. The potential further benefits of this regimen to enhance mental energy and other aspects of psycho-social well-being are unknown.
The aims of the present study include assessing the effects of the proposed diet and exercise intervention on 1) body composition, 2) strength and muscle quality, and 3) energy and fatigue symptoms.
Read the detailed description
Our target population includes 75 overweight or obese (BMI >/= 25kg/m^2) women between the ages of 65 and 80.
This study will use a parallel-arm design. After blocking on age and BMI, 75 overweight or obese (BMI ≥ 25 kg/m2) older females (65 - 80 y old) will be randomized into three groups; PRO or CARB diet combined with exercise (PRO+EX;n=25, CARB+EX; n=25) or PRO (n=25) without exercise for 6 months. All groups will have the goal of losing ~10% of initial body weight. We anticipate an adherence rate of 80% (n = 20 in each group remaining). At the initiation of the study, all subjects will be weight stable (within 2 kg) for past 6 mos and sedentary (defined as < 1h/wk or less than 2 exercise sessions per week in the last 6 months). Eligible participants will be planning to live in the community for the duration of the study. Exclusion criteria will include any chronic disease/condition that would not permit exercise or dietary restriction or alter interpretation of data. All subjects will require personal physician clearance prior to enrollment. Main outcome variables of interest are whole body composition, regional body composition, muscle strength endurance and quality, physical function, fatigue and biomarkers related to fatigue.
- Conditions
- Obesity
- Being tested
- Exercise, Higher Protein Diet, Conventional Carbohydrate Diet
- Keywords
- protein, physical function, muscle quality, fatigue, weight loss
- Medical subject headings
- Obesity, Fatigue, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
PRO+EX and CARB+EX groups will be prescribed an exercise program with required attendance of 3 nonconsecutive days per week. Exercise sessions will be supervised and conducted by trained graduate students in the Department of Kinesiology. Based on recommended practice, a program that combines flexibility and balance activities, weight bearing endurance exercise (walking) and resistance training to preserve lean mass will be prescribed. Each session will last ~75 min with a 35 min warm-up/aerobic exercise of mild to moderate intensity, ~30 min of resistance training, and finally, a ~10 min of balance and flexibility exercises during the cool-down period. Endurance training activities will vary but will all be weight-bearing.
Higher Protein DietBehavioural
PRO diet recommendations will include high quality proteins with an emphasis on lean meats with protein being targeted for every meal and snack. PRO will provide dietary protein (1.6 g.kg-1.d-1; ~30% of energy intake) with a ratio of carbohydrate/protein of <1.5 and dietary lipids at ~ 30% energy intake. Energy deficit will be determined by reducing estimated daily energy needs by ~500 kcal/d. Regarding beef intake specifically, the prescribed diet will include a minimum of one serving of beef per day, which is approximately 3 to 3.5 ounces or ~100 grams. This amount of lean cooked beef provides an average of ~25-30 grams of protein per day (www.beefnutrition.org/leanbeef.aspx). Our dietary prescription to the PRO groups that they add 3 ounces (and perhaps up to 3.5 ounces pending body size) of lean beef daily will provide an additional 25-30 grams of protein. This diet will also include 5 servings/day of vegetables and 2-3 servings/day of fruit.
Conventional Carbohydrate DietBehavioural
For the CARB group, the diet will provide dietary protein at 0.8 g.kg-1.d-1 (~ 18% of energy intake) with a ratio of carbohydrates/protein > 3.5 and dietary lipids at ~ 30% energy intake. Through nutrition education and counseling we will ensure that the CARB group meets the RDA for protein for women of 46 grams per day from a variety of plant and animal sources. Again, energy deficit will be determined by reducing estimated daily energy needs by ~500 kcal/d. Additional recommendations will include 5 servings/day of vegetables and 2-3 servings/day of fruit. Beef intake will be discouraged in the CARB group.
| Study group | Role | What they receive |
|---|---|---|
| Protein + Exercise | Experimental | PRO diet recommendations will include high quality proteins with an emphasis on lean meats, with protein being targeted for every meal and snack. PRO will provide dietary protein (1.6 g.kg-1.d-1; ~30% of energy intake) with a ratio of carbohydrate/protein of <1.5 and dietary lipids at ~ 30% energy intake. Energy deficit will be determined by reducing estimated daily energy needs by ~500 kcal/d. The prescribed diet will include a minimum of one serving of beef per day, which is approximately 3 to 3.5 ounces or ~100 grams. The exercise program will require attendance of 3 nonconsecutive days per week. A program that combines flexibility and balance activities, weight bearing endurance exercise (walking) and resistance training to preserve lean mass will be prescribed. Each session will last ~75 min with a 35 min warm-up/aerobic exercise of mild to moderate intensity, ~30 min of resistance training, and finally, a ~10 min of balance and flexibility exercises during the cool-down period. Receives: Behavioral: Exercise; Behavioral: Higher Protein Diet |
| Protein | Experimental | PRO diet recommendations will include high quality proteins with an emphasis on lean meats, with protein being targeted for every meal and snack. PRO will provide dietary protein (1.6 g.kg-1.d-1; ~30% of energy intake) with a ratio of carbohydrate/protein of <1.5 and dietary lipids at ~ 30% energy intake. Energy deficit will be determined by reducing estimated daily energy needs by ~500 kcal/d. The prescribed diet will include a minimum of one serving of beef per day, which is approximately 3 to 3.5 ounces or ~100 grams. Receives: Behavioral: Higher Protein Diet |
| Carbohydrate + Exercise | Experimental | Diet will provide dietary protein at 0.8 g.kg-1.d-1 (~ 18% of energy intake) with a ratio of carbohydrates/protein > 3.5 and dietary lipids at ~30% energy intake. Again, energy deficit will be determined by reducing estimated daily energy needs by ~500 kcal/d. The exercise program will require attendance of 3 nonconsecutive days per week. A program that combines flexibility and balance activities, weight bearing endurance exercise (walking) and resistance training to preserve lean mass will be prescribed. Each session will last ~75 min with a 35 min warm-up/aerobic exercise of mild to moderate intensity, ~30 min of resistance training, and finally, a ~10 min of balance and flexibility exercises during the cool-down period. Receives: Behavioral: Exercise; Behavioral: Conventional Carbohydrate Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Body Composition at 3 Months and 6 Months
Abdominal visceral and subcutaneous adiposity and muscle area and adipose infiltration of muscle will be measured using proton-weighted MR imaging. Subjects will be positioned feet first and supine in a 3.0 Tesla whole body imager (Signa, General Electric, Milwaukee, WI, USA). Imaging of the abdominal region and the thigh will be performed with two separate imaging sequences. The following pulse sequence parameters will be used: Fast Spin Echo-XL, TR/TE = 700/8.12 ms; Slice Thickness = 10mm; NEX = 3; Gap thickness = 5mm; ETL = 3; FA = 90; Number of slices = 18; Acquisition Matrix = 320 x 224 (Reconstructed = 512 x 512); FOV = 20cm; Voxel Size = .39 x .39 x 10 mm. Following high resolution T1 imaging, the images will be analyzed to determine the relative amount of fat in images using a modified Dixon method.
Whole body fat mass, lean mass and bone mass will also be assessed with DXA scanning.
Measured: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)
Change from Baseline in Strength & Muscle Quality at 3 Months and 6 Months
Using an isokinetic dynamometer (Biodex System Pro 4, Biodex Medical Systems, INC., New York) with the participant positioned according to manufacturer guidelines, four maximal knee extension and knee flexion contractions will be performed and measured at 0, 60 and 180 deg/sec with the testing order (left, right) and velocity (fast, slow, zero) randomized. The isometric (0 deg/sec) effort will be held for 4-seconds. A set of 25 consecutive maximal repetitions at 180 deg/sec will be used to assess muscular endurance.
Measured: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)
Change from Baseline in Energy & Fatigue Symptoms/Psychological Function at 3 Months and 6 Months
Subjects will take the following battery of psychological questionnaires at three timepoints: Profile of Mood States, Self-Motivation Inventory, Labeled Magnitude Scale, Affect Grid, SF-36, Pittsburgh Sleep Quality Index, Center for Epidemiological Studies Depression Scale, Perceived Stress Scale, WEL Self-Efficacy Questionnaire, Three Factor Eating Questionnaire, Mini-Mental Status, and the Trails B.
Measured: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)
Secondary outcomes (4)
Physical Functional Performance
A battery of tests will assess multiple components of physical function, including static and dynamic balance, agility, muscular strength and power, and aerobic capacity.
Measured: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)
Biomarkers Related to Fatigue
Fasting blood samples will be obtained and assayed for markers of systemic inflammation [C-reactive protein (CRP) and IL-6] and indicators of anemia (ferritin and vitamin B12) using commercially available ELISA kits samples run in triplicate. Timing for blood sampling for the inflammatory markers will occur greater than 24 but not less than 48 hours post-exercise in the morning after an overnight fast. With the training occurring 3 times per week generally in the morning, this means that if a person exercises on a Monday, their draw will occur on Wednesday prior to that exercise session. This timing also has maximal translational value in that it provides a "snap shot" of our lifestyle intervention. Participants will be queried regarding any acute illnesses during the 48-hours prior to the blood draw and again one week following this laboratory visit to ensure inflammatory status was not falsely elevated.
Measured: Baseline (Week 0), Post-Intervention (Week 24)
Physical Activity
Physical activity will be quantified using the Physical Activity Scale for the Elderly (PASE) which estimates the total level of household, occupational and leisure-time physical activities. Accelerometers (ActiGraph single-axis model, Health One Technology) will also be used to provide an objective measure of physical activity.
Measured: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)
Acceptability
We will use Nominal Group Technique (NGT) as our focus group technique to qualitatively evaluate the interventions. Essentially 2 small groups (10-15 each) within each treatment group will be brought together to generate barriers and facilitations to the program, share ideas and opinions, have a group discussion and then vote and rank major barriers and facilitations to the program. Notably our facilitator will tap both the exercise and diet aspects of our intervention.
Measured: Post-Intervention (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study start1 Jan 2013
- Primary completion31 Dec 2014
- Study completion1 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Evans, University of Georgia
- Investigators
- Ellen M Evans, PhD, Principal investigator, University of GeorgiaRachelle M Acitelli, MS, Study director, University of GeorgiaChad R Straight, MS, Study director, University of GeorgiaAlison C Berg, MS, RD, Study director, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893684
- Sponsor's protocol ID
- NCBA
- Other IDs
- NCBA
- Acronym
- ugaDIVAS
- Status last verified
- Sep 2017
- First submitted
- 4 Feb 2013
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Williams ER, Straight CR, Wilson HK, Lynall RC, Gregory CM, Evans EM. Weight Loss and Exercise Effects on Rate of Torque Development and Physical Function in Overweight Older Women. J Aging Phys Act. 2022 Nov 21;31(3):458-464. doi: 10.1123/japa.2022-0032. Print 2023 Jun 1.
PubMed 36410339Evans EM, Straight CR, Reed RA, Berg AC, Rowe DA, Johnson MA. Exercise and Protein Effects on Strength and Function with Weight Loss in Older Women. Med Sci Sports Exerc. 2021 Jan;53(1):183-191. doi: 10.1249/MSS.0000000000002429.
PubMed 32520876
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Higher Protein Weight Loss Diet and Exercise on Body Composition, Physical Function, and Fatigue in Overweight Older Women
- ClinicalTrials.gov ID
- NCT01893684
- Acronym / sponsor ID
- ugaDIVAS / NCBA
- Conditions
- Obesity
- Keywords
- protein, physical function, muscle quality, fatigue, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 9 Jul 2013 (estimated)
- 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.
The prevalence of obesity continues to increase at an alarming rate for all sectors of the population in the US. Obesity in the older adult cohort is of great concern as it is associated with reductions in mobility, declines in physical performance and increased risk for physical disability. With regard to body composition, a) fat mass has been determined to be a stronger predictor of mobility limitations than low muscle mass in older individuals and alternatively, b) leg lean mass has also been cited as a primary determinant of lower extremity physical function.
Obesity is related to increased levels of fatigue and lack of motivation and mental energy. Fatigue can be categorized as both a subjective perception and a performance decrement. Fatigue can be defined as a perceived lack of physical or mental energy while fatigability is another construct categorized by the degree of fatigue associated with activity in any dimension (i.e. physical, mental, emotional, and/or social).
The impact of a higher protein diet on muscle quality, muscle fatigability, perceptions of fatigue and systemic inflammation in older adults has not been well documented. The utility of a higher protein weight loss diet combined with resistance exercise training to augment fat mass loss, attenuate lean mass loss and improve muscle quality and physical function could potentially be of high value to overweight older women. The potential further benefits of this regimen to enhance mental energy and other aspects of psycho-social well-being are unknown.
The aims of the present study include assessing the effects of the proposed diet and exercise intervention on 1) body composition, 2) strength and muscle quality, and 3) energy and fatigue symptoms.
Detailed description
Our target population includes 75 overweight or obese (BMI >/= 25kg/m^2) women between the ages of 65 and 80.
This study will use a parallel-arm design. After blocking on age and BMI, 75 overweight or obese (BMI ≥ 25 kg/m2) older females (65 - 80 y old) will be randomized into three groups; PRO or CARB diet combined with exercise (PRO+EX;n=25, CARB+EX; n=25) or PRO (n=25) without exercise for 6 months. All groups will have the goal of losing ~10% of initial body weight. We anticipate an adherence rate of 80% (n = 20 in each group remaining). At the initiation of the study, all subjects will be weight stable (within 2 kg) for past 6 mos and sedentary (defined as < 1h/wk or less than 2 exercise sessions per week in the last 6 months). Eligible participants will be planning to live in the community for the duration of the study. Exclusion criteria will include any chronic disease/condition that would not permit exercise or dietary restriction or alter interpretation of data. All subjects will require personal physician clearance prior to enrollment. Main outcome variables of interest are whole body composition, regional body composition, muscle strength endurance and quality, physical function, fatigue and biomarkers related to fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Protein + Exercise | Experimental | Behavioral: Exercise, Behavioral: Higher Protein DietPRO diet recommendations will include high quality proteins with an emphasis on lean meats, with protein being targeted for every meal and snack. PRO will provide dietary protein (1.6 g.kg-1.d-1; ~30% of energy intake) with a ratio of carbohydrate/protein of <1.5 and dietary lipids at ~ 30% energy intake. Energy deficit will be determined by reducing estimated daily energy needs by ~500 kcal/d. The prescribed diet will include a minimum of one serving of beef per day, which is approximately 3 to 3.5 ounces or ~100 grams. The exercise program will require attendance of 3 nonconsecutive days per week. A program that combines flexibility and balance activities, weight bearing endurance exercise (walking) and resistance training to preserve lean mass will be prescribed. Each session will last ~75 min with a 35 min warm-up/aerobic exercise of mild to moderate intensity, ~30 min of resistance training, and finally, a ~10 min of balance and flexibility exercises during the cool-down period. |
| Protein | Experimental | Behavioral: Higher Protein DietPRO diet recommendations will include high quality proteins with an emphasis on lean meats, with protein being targeted for every meal and snack. PRO will provide dietary protein (1.6 g.kg-1.d-1; ~30% of energy intake) with a ratio of carbohydrate/protein of <1.5 and dietary lipids at ~ 30% energy intake. Energy deficit will be determined by reducing estimated daily energy needs by ~500 kcal/d. The prescribed diet will include a minimum of one serving of beef per day, which is approximately 3 to 3.5 ounces or ~100 grams. |
| Carbohydrate + Exercise | Experimental | Behavioral: Exercise, Behavioral: Conventional Carbohydrate DietDiet will provide dietary protein at 0.8 g.kg-1.d-1 (~ 18% of energy intake) with a ratio of carbohydrates/protein > 3.5 and dietary lipids at ~30% energy intake. Again, energy deficit will be determined by reducing estimated daily energy needs by ~500 kcal/d. The exercise program will require attendance of 3 nonconsecutive days per week. A program that combines flexibility and balance activities, weight bearing endurance exercise (walking) and resistance training to preserve lean mass will be prescribed. Each session will last ~75 min with a 35 min warm-up/aerobic exercise of mild to moderate intensity, ~30 min of resistance training, and finally, a ~10 min of balance and flexibility exercises during the cool-down period. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- Female
- Overweight or obese (BMI ≥ 25 kg/m2)
- 65-80 years of age
- English speaking
- Plan to live in the community for the duration of the study (~6 months)
Key exclusion criteria (14 listed)
- Normal weight (BMI < 25 kg/m2)
- Males
- Dietary restrictions that do not allow for the consumption of beef, as required by our dietary protocol.
- Weight loss surgery and/or weight loss medications usage.
- Any metal within the body and claustrophobia which precludes MRI assessment.
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 |
|---|---|---|
| ExercisePRO+EX and CARB+EX groups will be prescribed an exercise program with required attendance of 3 nonconsecutive days per week. Exercise sessions will be supervised and conducted by trained graduate students in the Department of Kinesiology. Based on recommended practice, a program that combines flexibility and balance activities, weight bearing endurance exercise (walking) and resistance training to preserve lean mass will be prescribed. Each session will last ~75 min with a 35 min warm-up/aerobic exercise of mild to moderate intensity, ~30 min of resistance training, and finally, a ~10 min of balance and flexibility exercises during the cool-down period. Endurance training activities will vary but will all be weight-bearing. | Behavioural | Carbohydrate + Exercise, Protein + Exercise |
| Higher Protein DietPRO diet recommendations will include high quality proteins with an emphasis on lean meats with protein being targeted for every meal and snack. PRO will provide dietary protein (1.6 g.kg-1.d-1; ~30% of energy intake) with a ratio of carbohydrate/protein of <1.5 and dietary lipids at ~ 30% energy intake. Energy deficit will be determined by reducing estimated daily energy needs by ~500 kcal/d. Regarding beef intake specifically, the prescribed diet will include a minimum of one serving of beef per day, which is approximately 3 to 3.5 ounces or ~100 grams. This amount of lean cooked beef provides an average of ~25-30 grams of protein per day (www.beefnutrition.org/leanbeef.aspx). Our dietary prescription to the PRO groups that they add 3 ounces (and perhaps up to 3.5 ounces pending body size) of lean beef daily will provide an additional 25-30 grams of protein. This diet will also include 5 servings/day of vegetables and 2-3 servings/day of fruit. | Behavioural | Protein, Protein + Exercise |
| Conventional Carbohydrate DietFor the CARB group, the diet will provide dietary protein at 0.8 g.kg-1.d-1 (~ 18% of energy intake) with a ratio of carbohydrates/protein > 3.5 and dietary lipids at ~ 30% energy intake. Through nutrition education and counseling we will ensure that the CARB group meets the RDA for protein for women of 46 grams per day from a variety of plant and animal sources. Again, energy deficit will be determined by reducing estimated daily energy needs by ~500 kcal/d. Additional recommendations will include 5 servings/day of vegetables and 2-3 servings/day of fruit. Beef intake will be discouraged in the CARB group. | Behavioural | Carbohydrate + Exercise |
Primary outcome
Change from Baseline in Body Composition at 3 Months and 6 Months
Time frame: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)
Abdominal visceral and subcutaneous adiposity and muscle area and adipose infiltration of muscle will be measured using proton-weighted MR imaging. Subjects will be positioned feet first and supine in a 3.0 Tesla whole body imager (Signa, General Electric, Milwaukee, WI, USA). Imaging of the abdominal region and the thigh will be performed with two separate imaging sequences. The following pulse sequence parameters will be used: Fast Spin Echo-XL, TR/TE = 700/8.12 ms; Slice Thickness = 10mm; NEX = 3; Gap thickness = 5mm; ETL = 3; FA = 90; Number of slices = 18; Acquisition Matrix = 320 x 224 (Reconstructed = 512 x 512); FOV = 20cm; Voxel Size = .39 x .39 x 10 mm. Following high resolution T1 imaging, the images will be analyzed to determine the relative amount of fat in images using a modified Dixon method. Whole body fat mass, lean mass and bone mass will also be assessed with DXA scanning.
Change from Baseline in Strength & Muscle Quality at 3 Months and 6 Months
Time frame: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)
Using an isokinetic dynamometer (Biodex System Pro 4, Biodex Medical Systems, INC., New York) with the participant positioned according to manufacturer guidelines, four maximal knee extension and knee flexion contractions will be performed and measured at 0, 60 and 180 deg/sec with the testing order (left, right) and velocity (fast, slow, zero) randomized. The isometric (0 deg/sec) effort will be held for 4-seconds. A set of 25 consecutive maximal repetitions at 180 deg/sec will be used to assess muscular endurance.
Change from Baseline in Energy & Fatigue Symptoms/Psychological Function at 3 Months and 6 Months
Time frame: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)
Subjects will take the following battery of psychological questionnaires at three timepoints: Profile of Mood States, Self-Motivation Inventory, Labeled Magnitude Scale, Affect Grid, SF-36, Pittsburgh Sleep Quality Index, Center for Epidemiological Studies Depression Scale, Perceived Stress Scale, WEL Self-Efficacy Questionnaire, Three Factor Eating Questionnaire, Mini-Mental Status, and the Trails B.
4 secondary outcomes
Physical Functional Performance
Time frame: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)
Biomarkers Related to Fatigue
Time frame: Baseline (Week 0), Post-Intervention (Week 24)
Physical Activity
Time frame: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)
Acceptability
Time frame: Post-Intervention (Week 24)
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 7 Sep 2017.
- Derived from this study: PubMed 36410339Williams ER, Straight CR, Wilson HK, Lynall RC, Gregory CM, Evans EM. Weight Loss and Exercise Effects on Rate of Torque Development and Physical Function in Overweight Older Women. J Aging Phys Act. 2022 Nov 21;31(3):458-464. doi: 10.1123/japa.2022-0032. Print 2023 Jun 1.
- Derived from this study: PubMed 32520876Evans EM, Straight CR, Reed RA, Berg AC, Rowe DA, Johnson MA. Exercise and Protein Effects on Strength and Function with Weight Loss in Older Women. Med Sci Sports Exerc. 2021 Jan;53(1):183-191. doi: 10.1249/MSS.0000000000002429.
- National Cattleman's Beef AssociationLink provided by the sponsor.
- UGA Department of KinesiologyLink provided by the sponsor.
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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.
Ellen M Evans, PhD principal investigator
University of Georgia
Rachelle M Acitelli, MS study director
University of Georgia
Chad R Straight, MS study director
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Higher Protein Diet and Conventional Carbohydrate Diet in people with Obesity, run by University of Georgia at 1 site in United States.
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 14 inclusion and 14 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 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from Baseline in Body Composition at 3 Months and 6 Months (time frame: Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01893684, which also lists 2 linked publications.
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 7 Sep 2017.