Dietary Intervention and Varying Physical Activity in Seniors



Status:Active, not recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:65 - 80
Updated:4/21/2016
Start Date:January 2013
End Date:December 2015

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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).

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.

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.

Inclusion Criteria:

1. Female

2. Overweight or obese (BMI ≥ 25 kg/m2)

3. 65-80 years of age

4. English speaking

5. Plan to live in the community for the duration of the study (~6 months)

6. Weight stable (within 2 kg) for the past 6 months

7. Sedentary (defined as <1 hr/week of physical activity or less than 2 exercise
sessions per week in the last 6 months)

8. Free of a history or diagnosis of renal insufficiency or disease

9. Willing to obtain physician clearance

10. Willing to be randomized to treatment groups

11. Free of any chronic disease/condition that would not permit exercise or dietary
restriction or alter interpretation of data.

12. Willing to meet all study requirements and randomization

13. Non-smoking and tobacco using

14. Able to obtain transportation to the UGA campus

Exclusion Criteria:

1. Normal weight (BMI < 25 kg/m2)

2. Males

3. Dietary restrictions that do not allow for the consumption of beef, as required by
our dietary protocol.

4. Weight loss surgery and/or weight loss medications usage.

5. Any metal within the body and claustrophobia which precludes MRI assessment.

6. Mini-mental state exam score < 25

7. Recent or history of unstable CVD

8. Cancer treatment within the last 5 years or active cancer

9. History of lung disease or COPD or severe asthma

10. Use of anti-inflammatory or steroid medications

11. History or severe arthritis or other medical condition that precludes ability to
exercise to level needed by study

12. Current diagnosis or history of balance disorders

13. History of mental disorders, dementia, clinical depression or other disorders that
preclude adherence to protocols

14. Current weight of 350 pounds of greater, due to weight restrictions on equipment
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Athens, Georgia 30602
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