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

• Sponsor: South Dakota State University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05581953
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25.6
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Aging	Other: Omnivorous; Other: Vegetarian	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Care Provider, 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.
• Primary Purpose: Other
• 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
• Anticipated Study Start Date: Oct 15, 2022
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omnivorous Animal protein-lean pork	Other: Omnivorous; Pork-added plant-forward diet
Other: Vegetarian Lacto-ovo-vegetarian without any meat	Other: Vegetarian; Plant-forward lacto-ovo-vegetarian diet

Outcome Measures

Primary Outcome Measures

1. Concentration of Homocysteine in blood [Time frame: 16 weeks]

   Using Microplate assay

2. Concentration of Ferritin in blood [Time frame: 16 weeks]

   Using Microplate assay

3. Frequency of Sit-to-stand for strength assessment [Time frame: 16 weeks]

   Functional assessment test

Secondary Outcome Measures

1. Fasting blood glucose concentration in blood [Time frame: 16 weeks]

   Using Glucometer

2. Concentration of ApoA in blood [Time frame: 16 weeks]

   Using Microplate assay

3. Concentration of ApoB in blood [Time frame: 16 weeks]

   Using Microplate assay

4. Concentration of Lipid panel in blood [Time frame: 16 weeks]

   Cholestech ldx

5. Concentration of Iron status in blood [Time frame: 16 weeks]

   Using Microplate assay

6. Concentration of vit B12 in blood [Time frame: 16 weeks]

   Using Microplate assay

7. Concentration of IGF-1 in blood [Time frame: 16 weeks]

   Using Microplate assay

8. Concentration of IGF-BP3 in blood [Time frame: 16 weeks]

   Using Microplate assay

9. Concentration of Fasting insulin in blood [Time frame: 16 weeks]

   Using Microplate assay

10. HOMA-IR index using insulin and glucose concentration in blood [Time frame: 16 weeks]

    Standard equation

11. Concentration of Complex lipids panel in blood [Time frame: 16 weeks]

    Using LC/MS based assay

12. Concentration of IL-6 in blood [Time frame: 16 weeks]

    Using Microplate assay

13. Concentration of HsCRP in blood [Time frame: 16 weeks]

    Using Microplate assay

14. Vascular age score, calculated using lipid markers in blood [Time frame: 16 weeks]

    Standard equation

15. Height in cm [Time frame: 16 weeks]

    Measurements

16. Body Weight in kg [Time frame:16 weeks]

    Measurements

17. Blood pressure in mm Hg [Time frame: 16 weeks]

    Upper arm cuff

18. heart rate in beats per minute [Time frame: 16 weeks]

    Upper arm cuff

19. Grip force per kg mass [Time frame: 16 weeks]

    Using Dynamometer

20. Muscle strength using Isokinetic muscle testing [Time frame: 16 weeks]

    Biodex Ergometer

21. Balance assessment using balance and gait score [Time frame: 16 weeks]

    Mechanography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Dakota State University, Wagner Hall 416	Brookings	South Dakota	United States	57007

Sponsors and Collaborators

• South Dakota State University

Investigators

• Principal Investigator: Moul Dey, Ph.D., South Dakota State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Moul Dey, Professor, South Dakota State University
• ClinicalTrials.gov Identifier: NCT05581953
• Other Study ID Numbers: IRB-2209010-EXP
• First Posted: Oct 17, 2022
• Last Update Posted: Oct 17, 2022
• Last Verified: Oct 1, 2022

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

Study Results

No Results Posted as of Oct 17, 2022