Peanut Consumption to Augment Adaptations to Concurrent Resistance and Aerobic Exercise Training

• ClinicalTrials.gov Identifier: NCT05932875
• Recruitment Status: Recruiting
• First Posted: July 6, 2023
• Last Update Posted: July 6, 2023
• Sponsor: Southwestern University
• Information provided by (Responsible Party): Edward Merritt, Southwestern University

Tracking Information

• First Submitted Date: June 27, 2023
• First Posted Date: July 6, 2023
• Last Update Posted Date: July 6, 2023
• Actual Study Start Date: May 30, 2023
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 27, 2023)

• Total Lean Mass [ Time Frame: From baseline to the end of the training program at 16 weeks. ]
  Amount of lean mass as determined by dual energy x-ray absorptiometry scan
• Muscle strength [ Time Frame: From baseline to the end of the training program at 16 weeks. ]
  Isometric grip and knee extension strength, as well as dynamic 1-repitition maximum strength of bench press, leg press, overhead press, knee extension
• Cardiorespiratory fitness [ Time Frame: From baseline to the end of the training program at 16 weeks. ]
  Maximal oxygen consumption as determined by graded treadmill test

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Peanut Consumption to Augment Adaptations to Concurrent Resistance and Aerobic Exercise Training
• Official Title: PEANUT CONSUMPTION TO AUGMENT ADAPTATIONS TO CONCURRENT RESISTANCE EXERCISE AND AEROBIC EXERCISE TRAINING
• Brief Summary: The primary objective of this proposal is to determine the effects of post-exercise peanut consumption on long-term aerobic and resistance exercise training adaptations in middle-aged men and women. We will determine the impact of peanuts on exercise training-induced improvements in muscle strength, gains in muscle mass, and improvements in cardiorespiratory fitness and metabolic capacity.

Detailed Description

Positive health benefits of peanut consumption are well-known, but potential benefits have yet to be discovered, especially in regard to fitness. This project will directly determine the benefits of peanut consumption as part of a long-term aerobic and resistance exercise training program in middle-aged adults.

Proper nutrition is necessary for the body to properly recover and adapt to an exercise bout and thereby realize the health benefits of the exercise. The period of time immediately after exercise is even more important in realizing these adaptations. With relatively higher amounts of fats, peanuts are often overlooked as a nutritious, post-exercise snack, because they might not be optimal for athletic performance. However, for a middle-aged adult performing the recommended amount of weekly physical activity, the protein and carbohydrate content of peanuts is sufficient to provide the macronutrients necessary to achieve the beneficial health adaptations associated with exercise training. Other micronutrients and healthy fats in peanuts, might confer further benefits beyond those of other post-exercise supplements, however, this has yet to be elucidated.

The randomized, placebo-controlled, clinical trial will provide valuable information on the health benefits of peanut consumption and determine if peanuts can augment beneficial exercise training adaptations in middle-aged adults. We will recruit a group of 48 adults (30-55 years) who do not regularly exercise to undertake a 4-month exercise training program. The program, proven to increase muscle mass and improve cardiorespiratory fitness, will consist of 4 days per week of structured workouts (2/week resistance, 2/week aerobic). Participants will be randomly assigned to consume either a peanut-based snack or an isocaloric, non-peanut carbohydrate-based snack immediately after each exercise session. A comprehensive health and fitness assessment will be conducted before training, after 2-months of training, and after 4-months of training. Measures of cardiorespiratory fitness, muscular fitness, and body composition will be assessed.

Anticipated Products & Potential Outcomes When completed, this study will provide the first evidence of the effect of post-exercise peanut consumption on long-term exercise training adaptations to both aerobic and resistance training in middle-aged adults. This will be the first study to determine the effects of peanut consumption with aerobic exercise training, and the longest study on resistance exercise training and peanut consumption. With the mid-training 2-month timepoint, we will be able to compare our results to those of similar resistance training peanut studies, but importantly follow them for longer, when resistance training adaptations are likely to be more apparent. We hypothesize that the peanut group will experience greater gains in muscle strength and hypertrophy than the placebo group. We hypothesize that the peanut and placebo group will have similar improvements in cardiorespiratory fitness and body composition (higher total body lean mass leading to relatively lower body fat). This would be an important finding to prove that, despite their higher fat content, peanut consumption does not lead to negative effects on body composition nor prevent cardiorespiratory adaptions due to exercise training. Overall, the results are likely to demonstrate that peanuts are a simple, inexpensive, and effective post-exercise health food capable of further enhancing the beneficial effects of exercise training.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Muscle Strength
• Cardiorespiratory Fitness
• Body Composition
• Peanut Consumption

Intervention

Other: Exercise Training

4 day per week concurrent exercise training program

Study Arms

• Active Comparator: Peanut/Carbohydrate Consumption Exercise Training
  Participants in this group will undergo 16 weeks of concurrent exercise training (4 sessions/week) consuming a peanut-based rice/oatmilk smoothie after each workout
  Intervention: Other: Exercise Training
• Placebo Comparator: Carbohydrate Consumption Exercise Training
  Participants in this group will undergo 16 weeks of concurrent exercise training (4 sessions/week) consuming a rice/oatmilk smoothie after each workout
  Intervention: Other: Exercise Training

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 27, 2023): 48
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2024
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Men and women 30- 55 years old, healthy, non-smoking, with no exercise training in the previous 6 months, not currently attempting to gain or lose weight, body mass index < 35, with no need for physician clearance prior to beginning an exercise program as determined by American College of Sports Medicine guidelines.

Exclusion Criteria:

• Volunteers will be excluded for neurological or musculoskeletal disorders; uncontrolled hypertension (resting systolic blood pressure > 180 mmHg or diastolic > 120 mmHg; unstable or exercise-induced angina pectoris; diabetes mellitus; any other medical condition that would interfere with testing or training; androgen (e.g., testosterone), anabolic (e.g., GH, IGF-I), or catabolic (e.g. GLP-1 agonists) therapy; food allergy to peanuts or dairy products; pregnant people or people actively trying to get pregnant; on a special diet that restricts protein/carbs/sugar/fat.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Ed Merritt, PhD; 5128631651; merritte@southwestern.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05932875
• Other Study ID Numbers: SP23_20
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: IRB approval does not allow for IPD to be shared.

• Current Responsible Party: Edward Merritt, Southwestern University
• Original Responsible Party: Same as current
• Current Study Sponsor: Southwestern University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Southwestern University
• Verification Date: June 2023