Dietary Intervention and Varying Physical Activity in Seniors

NCT01893684 | Completed

• 1 other identifier: NCBA
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity

Keywords

protein; physical function; muscle quality; fatigue; weight loss

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)

Secondary Outcomes (4)

• Physical Functional Performance

  Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)

• Biomarkers Related to Fatigue

  Baseline (Week 0), Post-Intervention (Week 24)

• Physical Activity

  Baseline (Week 0), Midpoint (Week 12), Post-Intervention (Week 24)

• Acceptability

  Post-Intervention (Week 24)

Study Arms (3)

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.

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.

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.

Behavioral: Exercise; Behavioral: Conventional Carbohydrate Diet

Interventions

Exercise BEHAVIORAL

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.

Carbohydrate + Exercise; Protein + Exercise

Higher Protein Diet BEHAVIORAL

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.

Protein; Protein + Exercise

Conventional Carbohydrate Diet BEHAVIORAL

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.

Carbohydrate + Exercise

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Female
• Overweight or obese (BMI ≥ 25 kg/m2)
• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Georgia: lead

Study Sites (1)

University of Georgia

Athens, Georgia, 30606, United States

Location

Related Publications (2)

• 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.

  PMID: 36410339 DERIVED

• Evans 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.

  PMID: 32520876 DERIVED

Related Links

• National Cattleman's Beef Association
• UGA Department of Kinesiology

MeSH Terms

Conditions

Obesity; Fatigue; Weight Loss

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ellen M Evans, PhD

  University of Georgia

  PRINCIPAL INVESTIGATOR

• Rachelle M Acitelli, MS

  University of Georgia

  STUDY DIRECTOR

• Chad R Straight, MS

  University of Georgia

  STUDY DIRECTOR

• Alison C Berg, MS, RD

  University of Georgia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: July 9, 2013
• Study Start: January 1, 2013
• Primary Completion: December 31, 2014
• Study Completion: July 1, 2015
• Last Updated: September 7, 2017

Record last verified: 2017-09

Locations

US (1)