Clinical trial NCT05581953: Protein-Distinct Macronutrient-Equivalent Diet 2
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Aging
Lead sponsor: South Dakota State University
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 59
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Concentration of Fasting insulin in blood
timeFrame: Time frame: 16 weeks
measure: Concentration of Ferritin in blood
timeFrame: Time frame: 16 weeks
measure: Concentration of Homocysteine in blood
timeFrame: Time frame: 16 weeks
measure: Frequency of Sit-to-stand for strength assessment
timeFrame: Time frame: 16 weeks
Secondary outcomes:
measure: Fasting blood glucose concentration in blood
timeFrame: Time frame: 16 weeks
measure: Concentration of FGF21 in blood
timeFrame: Time frame: 16 weeks
measure: HOMA-IR index using insulin and glucose concentration in blood
timeFrame: Time frame: 16 weeks
measure: Concentration of ApoB in blood
timeFrame: Time frame: 16 weeks
measure: Concentration of Lipid panel in blood
timeFrame: Time frame: 16 weeks
measure: Concentration of IGF-1 in blood
timeFrame: Time frame: 16 weeks
measure: Concentration of Complex lipids panel in blood
timeFrame: Time frame: 16 weeks
measure: Concentration of C-peptide
timeFrame: Time frame: 16 weeks
measure: Concentration of HsCRP in blood
timeFrame: Time frame: 16 weeks
measure: Height in cm
timeFrame: Time frame: 16 weeks
measure: Body Weight in kg
timeFrame: Time frame:16 weeks
measure: Blood pressure in mm Hg
timeFrame: Time frame: 16 weeks
measure: heart rate in beats per minute
timeFrame: Time frame: 16 weeks
measure: Grip force per kg mass
timeFrame: Time frame: 16 weeks
Other outcomes:
Locations:
city: Brookings
country: United States
facility: South Dakota State University, Wagner Hall 416
state: South Dakota
Study officials:
affiliation: South Dakota State University
name: Moul Dey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: