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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04232254
Other study ID # 20243
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 1, 2023

Study information

Verified date July 2022
Source University of Illinois at Urbana-Champaign
Contact Andrew T Askow, MS
Phone 608-630-0237
Email askow2@illinois.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Adopting a healthy eating pattern is important for meeting dietary recommendations and weight management. Although less clear, it seems reasonable to assume that the eating patterns we typically follow can also affect our psychological wellbeing. As such, healthy eating patterns are often adapted to suit one's personal preference. For example, many people choose to follow a vegetarian-style eating pattern whereby meat, poultry, and seafood are excluded from the diet. However, current research suggests that vegetarian eating patterns may result in decreased synthesis of new muscle proteins when compared to the typical meat-based US-style diet. This ultimately leads to reduced muscle quality and mass which increases the risk of dependence and mobility limitations later in life. Another important factor to consider when adapting a healthy eating pattern is the frequency and distribution of meals throughout the day. In the US, protein intake is typically skewed throughout the day such that people consume more protein at dinner when compared to breakfast. This skewed distribution combined with a low meal frequency (3 meals per day) can also sacrifice the rate of muscle protein synthesis. As such, it is important to investigate the interaction between food choices, meal frequency, and protein distribution to promote muscle health and prevent development of disease and disability. In addition, it is also important to understand how these eating patterns affect enjoyment and pleasure following meals. This work will help to determine healthy eating patterns that promote muscle health and psychological wellbeing.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Age 20-40 - Pre-menopausal - Recreationally active - Weight stable for prior 6 months - Consumption of meat-based diet for >6 months Exclusion Criteria: - Age outside of range (20 - 40) - Pregnancy - Irregular menstrual cycles - Participation in previous research using 2H2O or [13C6]phenylalanine - Participation in other ongoing research that interferes with this study (e.g., conflicting diet, activity interventions, etc.) - Any hospitalization or surgery for a metabolic, cardiovascular, or neuromusculoskeletal complication within the past year - Allergy or hypersensitivity to local anesthetics, latex, or adhesives (bandages, medical tape, etc.) - Excess scarring after injury - History of excess bleeding after cut - Chronic or frequent dizziness/fainting, and arm or leg weakness/numbness - Arthritis - Tumors - Mental Illness - Hepatorenal, cardiovascular musculoskeletal, autoimmune, or neurological disease or disorder - Predisposition to hypertrophic scarring or keloid formation - Physical activity limitations - Consumption of ergogenic-levels of dietary supplements that may affect muscle mass (e.g., creatine, HMB), insulin-like substances, or anabolic/catabolic pro-hormones (e.g., DHEA) within 6 weeks prior to participation - Consumption of thyroid, androgenic, or other medications known to affect endocrine function - Consumption of medications known to affect protein metabolism (e.g., prescription-strength corticosteroids, nonsteroidal anti-inflammatories, or acne medication) - Unwillingness to comply with study procedures - Weight unstable (variation >5% of bodyweight in last 6-12 months) - Pregnancy - Allergy to dairy product or lactose intolerance - Current or previous tobacco use with last 6 months - Obesity (body mass index; BMI > 30 kg m-2) - Score of less than 14 or greater than 24 on Godin-Shephard Leisure-Time Physical Activity Questionnaire

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Animal-based Protein Foods
Participants will consume animal-based protein foods.
Skewed Protein Distribution
Participants will consume 3 meals per day consisting of 10-, 30-, 60% of dietary protein for breakfast, lunch, and dinner, respectively.
Plant-based Protein Foods
Participants will consume plant-based protein foods.
Balanced Protein Distribution
Participants will consume 5 meals per day consisting of 20% of dietary protein per meal.

Locations

Country Name City State
United States Freer Hall Urbana Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign National Cattlemen's Beef Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare fractional synthesis rate of myofibrillar proteins to different dietary protein food sources and meal frequencies Rate of building new protein in skeletal muscle contractile protein Day 1 - Day 9
Primary Compare fractional synthesis rate of myofibrillar proteins to different dietary protein food Rate of building new protein in skeletal muscle contractile protein During the 3-hour post-absorptive period prior to ingestion of a mixed meal containing either plant- or animal based protein and throughout the 5-hour post-prandial period following meal ingestion
Secondary Valence (Pleasantness or Unpleasantness) Measurement of feelings of un/pleasantness via survey responses to a measure of valence (Feeling Scale) Immediately prior to workout, immediately post workout, and immediately post meal on habituation days 2, 4, and 6 and intervention days 3, 5, and 7
Secondary Arousal (Alertness) Measurement of feelings of alertness to via survey responses to a measure of arousal (Felt Arousal Scale) Immediately prior to workout, immediately post workout, and immediately post meal on habituation days 2, 4, and 6 and intervention days 3, 5, and 7
Secondary Arousal (Alertness) Measurement of feelings of alertness to via survey responses to a measure of arousal (Activation-Deactivation Adjective Check List). Immediately prior to workout, immediately post workout, and immediately post meal on habituation days 2, 4, and 6 and intervention days 3, 5, and 7
Secondary Plasma Amino Acid Concentration Concentration of amino acids in plasma as determined by LC/MS/MS During the 3-hour post-absorptive period prior to ingestion of a mixed meal containing either plant- or animal based protein and throughout the 5-hour post-prandial period following meal ingestion
Secondary Plasma Insulin Concentration Concentration of insulin plasma as determined via commercially-available ELISA kit During the 3-hour post-absorptive period prior to ingestion of a mixed meal containing either plant- or animal based protein and throughout the 5-hour post-prandial period following meal ingestion
Secondary Anabolic Signaling Phosphorylation of anabolic signaling targets as determined via Western blotting Prior to, 2 hours, and 5 hours following ingestion of a mixed meal containing either plant- or animal based protein
Secondary Whole-body Leucine Oxidation Leucine oxidation rates will be assessed using the a-[13C]ketoisocaproate reciprocal pool model During the 3-hour post-absorptive period prior to ingestion of a mixed meal containing either plant- or animal based protein and throughout the 5-hour post-prandial period following meal ingestion
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