Role of Lean-pork Within a Plant-based Dietary Pattern

Healthy Aging Clinical Trial

Official title:

The Role of Lean-pork Within a Plant-based Dietary Pattern for Improving Iron Reserve, Muscle-fitness, and Markers of Health Span in Older Adults: A Multi-disciplinary Randomized Controlled Feeding Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05581953
• Other study ID #: IRB-2209010-EXP
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: South Dakota State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The central hypothesis is that the addition of lean pork to a healthy plant-only diet will enhance nutrient adequacy to attenuate markers of cognitive decline, promote muscular fitness, and maintain immuno-metabolic functions for improved healthspan. A well-designed, randomized, controlled, crossover, feeding study with clinical and molecular mechanistic endpoints is proposed to provide the most definitive level of evidence logistically possible in humans and to establish the role of lean pork in healthspan promotion. Utilizing an all-food-provided (dine-in and take-out) design over 18 weeks (rolling recruitment, 8+8, 2w washout), a comprehensive assessment of metabolomics, system biology, physical, and physiological markers that indicate the risk of age-related comorbidities-critical micronutrient deficiency, frailty, metabolic dysfunctions, and cognitive decline, is proposed in upper Midwesterners 65 years and older. A plant-forward pork-added diet will be compared with an isocaloric plant-only control for over 250 outcome measures using mixed-effects modeling adjusting for covariates in R. n=15/diet/arm i.e., a total starting sample size of n=30 is proposed for 90% power.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 59
• Est. completion date: December 31, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• generally good health status based on one routine physical in the past 15 months, current health status
• normal HbA1C, weigh 110 lb or more
• Age 65 years or more, generally healthy, all races and both sexes
• generally practicing a meat-based dietary pattern, do not have any special dietary requirement, and
• willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.

Exclusion Criteria:

• medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use
• Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight.
• impaired kidney functions
• Active history of cancer, diabetes, heart, liver, and kidney diseases
• major gastrointestinal disorders in the past 3 months
• history of heart attacks or stroke
• Unable to meet in-person visit requirements for dining, picking up meals, and tests
• Any mental health condition that would affect the ability to provide written informed consent.
• If they had not had a routine health checkup during the 12 months prior to recruitment.
• If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverage during the study period.

Related Conditions & MeSH terms

• Healthy Aging

Intervention

Other:
• Omnivorous
Pork-added plant-forward diet
• Vegetarian
Plant-forward lacto-ovo-vegetarian diet

Locations

Country	Name	City	State
United States	South Dakota State University, Wagner Hall 416	Brookings	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
South Dakota State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Homocysteine in blood	Using Microplate assay	Time frame: 16 weeks
Primary	Concentration of Ferritin in blood	Using Microplate assay	Time frame: 16 weeks
Primary	Frequency of Sit-to-stand for strength assessment	Functional assessment test	Time frame: 16 weeks
Secondary	Fasting blood glucose concentration in blood	Using Glucometer	Time frame: 16 weeks
Secondary	Concentration of ApoA in blood	Using Microplate assay	Time frame: 16 weeks
Secondary	Concentration of ApoB in blood	Using Microplate assay	Time frame: 16 weeks
Secondary	Concentration of Lipid panel in blood	Cholestech ldx	Time frame: 16 weeks
Secondary	Concentration of Iron status in blood	Using Microplate assay	Time frame: 16 weeks
Secondary	Concentration of vit B12 in blood	Using Microplate assay	Time frame: 16 weeks
Secondary	Concentration of IGF-1 in blood	Using Microplate assay	Time frame: 16 weeks
Secondary	Concentration of IGF-BP3 in blood	Using Microplate assay	Time frame: 16 weeks
Secondary	Concentration of Fasting insulin in blood	Using Microplate assay	Time frame: 16 weeks
Secondary	HOMA-IR index using insulin and glucose concentration in blood	Standard equation	Time frame: 16 weeks
Secondary	Concentration of Complex lipids panel in blood	Using LC/MS based assay	Time frame: 16 weeks
Secondary	Concentration of IL-6 in blood	Using Microplate assay	Time frame: 16 weeks
Secondary	Concentration of HsCRP in blood	Using Microplate assay	Time frame: 16 weeks
Secondary	Vascular age score, calculated using lipid markers in blood	Standard equation	Time frame: 16 weeks
Secondary	Height in cm	Measurements	Time frame: 16 weeks
Secondary	Body Weight in kg	Measurements	Time frame:16 weeks
Secondary	Blood pressure in mm Hg	Upper arm cuff	Time frame: 16 weeks
Secondary	heart rate in beats per minute	Upper arm cuff	Time frame: 16 weeks
Secondary	Grip force per kg mass	Using Dynamometer	Time frame: 16 weeks
Secondary	Muscle strength using Isokinetic muscle testing	Biodex Ergometer	Time frame: 16 weeks
Secondary	Balance assessment using balance and gait score	Mechanography	Time frame: 16 weeks