Impact of Beef on Metabolites and Inflammation

NCT05460754 | Completed Results

• 1 other identifier: OAEC Grant 2022
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Western omnivore diets tend to use beef as a good source of protein. Studies have shown cattle who are fed different diets results in varying nutritional meat profiles in terms of amino acids, types and relative amounts of fat, and other nutrients. While overlap between organic and conventionally raised beef is expected, dietary impacts on human health are potentially meaningful as small changes in diet may have large downstream effects on human metabolism. To date, no studies have been conducted in humans that evaluate the health effects of organic grass-fed beef consumption to conventionally-fed beef consumption. To fill this gap in research, the investigators propose to identify metabolic differences in response to consumption of organic grass-fed compared to conventional-fed beef on a wide array of blood borne nutrients including amino acids, lipids, bile acids, and hundreds of other metabolites. This comprehensive analysis is expected to differentiate nutritional and metabolic impacts relevant to human health and provide a foundation for future research. The purpose of this study is to determine how a beef steak meal may affect bile acids in the gut, inflammation, and the metabolic health of healthy individuals. This research will investigate the following questions:

1. 1.How do specific foods affect bile acids in the blood?
2. 2.How do specific foods changes inflammation, metabolism, and other health measures? If researchers learn how food affects different health related markers in the blood and how that may influence health, then this information can be used to do more research to improve the health of people in a future study.

Conditions

Healthy

Keywords

Organic grass-fed; Conventional-fed

Outcome Measures

Primary Outcomes (1)

• Postprandial Serum Lipids

  Concentration of postprandial serum triglycerides, high-density lipoproteins, cholesterol (mM)

  1 day

Secondary Outcomes (3)

• Postprandial Serum Inflammatory Cytokines

  1 day

• Postprandial Serum Glucose

  1 day

• Postprandial Serum Insulin

  1 day

Study Arms (2)

Organic grass-fed beef, then conventional-fed beef

EXPERIMENTAL

Participants receive an organic grass-fed steak meal in the morning. After a washout period of at least 7 days, they then receive the alternative meal, conventional-fed steak meal in the morning.

Behavioral: Conventional-fed beef; Behavioral: Organic grass-fed beef

Conventional-fed beef, then organic grass-fed beef

EXPERIMENTAL

Participants receive a conventional-fed steak meal in the morning. After a washout period of at least 7 days, they then receive the alternative meal, an organic grass-fed steak meal in the morning.

Behavioral: Conventional-fed beef; Behavioral: Organic grass-fed beef

Interventions

Conventional-fed beef BEHAVIORAL

Participants in the conventional-fed treatment of the study will consume a conventional-fed steak meal for breakfast one morning.

Conventional-fed beef, then organic grass-fed beef; Organic grass-fed beef, then conventional-fed beef

Organic grass-fed beef BEHAVIORAL

Participants in the organic grass-fed treatment of the study will consume a organic grass-fed steak meal for breakfast one morning.

Conventional-fed beef, then organic grass-fed beef; Organic grass-fed beef, then conventional-fed beef

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults 18-45 years old; equal numbers male and female
• Body mass index between 18-27 kg/m\^2.

You may not qualify if:

• Allergy to red meat
• Pregnant or Lactating
• Taking cholesterol, lipid-lowering, or anti-inflammatory medication(s)
• Antibiotic Use within the past 90 days.
• Existing gallbladder condition or gallbladder removal
• Other health concerns or conditions that may interfere with study participation

Sponsors & Collaborators

• Montana State University: lead
• Organic Advisory and Education Council: collaborator

Study Sites (1)

Nutrition Research Laboratory

Bozeman, Montana, 59717, United States

Location

Results Point of Contact

• Title: Dr. Mary P Miles
• Organization: Montana State University

mmiles@montana.edu

406 994-6678

Study Officials

• Mary Miles, PhD

  Montana State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator) Organic grass-fed and conventional-fed steak meals were designed to be comparable in size, taste and appearance. The steaks are cut, measured in terms of size and appearance and coded prior to receipt by the research team. Randomization is for order of coded steaks.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The design is 2 x 2 crossover design, where the healthy adults will be randomized into Organic grass-fed and conventional-fed conditions for the first round of data collection and then crossover to the other condition for the second round of data collection.

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: September 19, 2022
• Primary Completion: March 21, 2023
• Study Completion: March 21, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)