Healthy Aging
Conditions
Brief summary
The central hypothesis is that the addition of minimally processed lean pork to a healthy plant-forward low ultra-processed diet will enhance nutrient adequacy, promote muscular fitness, and maintain 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 minimally processed 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 minimally processed plant-forward diet with or without added pork will be compared 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.
Interventions
OTHEROmnivorous
Pork-added plant-forward diet
OTHERNo meat
Plant-forward no meat
Sponsors
South Dakota State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Blinding will be implemented to the extent possible. A researcher, unaware of the study goals and not involved with downstream data analyses will use a 1:1 block randomization to allocate participants to the diets in the first arm. Food service personnel (care provider) will not be aware of study goals and allocations. Metabolomic assays will be run in a blinded manner.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Generally good health status based on one routine physical in the past 15 months * 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 * Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection. * Willing to consume pork as sole meat source during the feeding study.
Exclusion criteria
* Tobacco/drug/alcohol use * Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight. * 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 were unwilling to abstain from taking certain nutritional supplements, alcohol, or non-study foods during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Fasting insulin in blood | Time frame: 16 weeks | Using Microplate assay |
| Concentration of Ferritin in blood | Time frame: 16 weeks | Using Microplate assay |
| Concentration of Homocysteine in blood | Time frame: 16 weeks | Using Microplate assay |
| Frequency of Sit-to-stand for strength assessment | Time frame: 16 weeks | Functional assessment test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Lipid panel in blood | Time frame: 16 weeks | Cholestech ldx |
| Concentration of IGF-1 in blood | Time frame: 16 weeks | Using Microplate assay |
| Concentration of Complex lipids panel in blood | Time frame: 16 weeks | Using LC/MS based assay |
| Concentration of C-peptide | Time frame: 16 weeks | Using Microplate assay |
| Concentration of HsCRP in blood | Time frame: 16 weeks | Using Microplate assay |
| Fasting blood glucose concentration in blood | Time frame: 16 weeks | Using Glucometer |
| Body Weight in kg | Time frame:16 weeks | Measurements |
| Blood pressure in mm Hg | Time frame: 16 weeks | Upper arm cuff |
| heart rate in beats per minute | Time frame: 16 weeks | Upper arm cuff |
| Grip force per kg mass | Time frame: 16 weeks | Using Dynamometer |
| Height in cm | Time frame: 16 weeks | Measurements |
| Concentration of FGF21 in blood | Time frame: 16 weeks | Using Microplate assay |
| HOMA-IR index using insulin and glucose concentration in blood | Time frame: 16 weeks | Standard equation |
| Concentration of ApoB in blood | Time frame: 16 weeks | Using Microplate assay |
Countries
United States
Outcome results
None listed