High Healthy Eating Index Diet with Further Processed Meat for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Healthy Subjects (HS)
High Healthy Eating Index Diet with Further Processed Meat - Other
Eligibility
18+
All Sexes
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Study Summary

The objective of this study is to investigate how different types of meat consumed with two different dietary patterns affect risk for disease.

Treatment Effectiveness

Study Objectives

18 Primary · 16 Secondary · Reporting Duration: At the beginning and end of diet period 1 (week 1 and week 4), diet period 2 (week 5 and week 9), diet period 3 (week 10 and week 14), and diet period 4 (week 15 and week 19).

Day 3
24-Hour Dietary Recall
Week 19
Assessment of hunger and satiety.
Day 141
Apolipoproteins
Betaine
Bile Acids
Blood Pressure
C-reactive protein
Carnitine Concentration
Choline Concentration
Glucose
Gut microbiota
HDL Cholesterol Concentration
IL6 Concentration
Insulin Concentration
LDL Cholesterol Lipoproteins
Lipoproteins
Low Density Lipoprotein particle size
Serum amyloid A protein
TMA (trimethylamine) Concentration
TMAO (trimethylamine N-oxide) Concentration
Total Cholesterol Concentration
Triglycerides
Week 19
Assessment of diet satisfaction.
Biles acids will be measured in feces.
Blood pressure will be measured.
Carnitine
Glucose
Insulin will be measured in blood.
Lipids and lipoproteins will be measured in blood.
Microbiota will be measured in feces.
Systemic inflammation will be measured in blood.
Week 1
Assessment of diet history.
Week 19
Diet Satisfaction
Hunger and Satiety

Trial Safety

Trial Design

4 Treatment Groups

High Healthy Eating Index Diet with Further Processed Meat
1 of 4
High Healthy Eating Index Diet with Minimally Processed Meat
1 of 4
Typical Healthy Eating Index Diet with Further Processed Meat
1 of 4
Typical Healthy Eating Index Diet with Minimally Processed Meat
1 of 4

Experimental Treatment

60 Total Participants · 4 Treatment Groups

Primary Treatment: High Healthy Eating Index Diet with Further Processed Meat · No Placebo Group · N/A

High Healthy Eating Index Diet with Further Processed Meat
Other
Experimental Group · 1 Intervention: High Healthy Eating Index Diet with Further Processed Meat · Intervention Types: Other
High Healthy Eating Index Diet with Minimally Processed Meat
Other
Experimental Group · 1 Intervention: High Healthy Eating Index Diet with Minimally Processed Meat · Intervention Types: Other
Typical Healthy Eating Index Diet with Further Processed Meat
Other
Experimental Group · 1 Intervention: Typical Healthy Eating Index Diet with Further Processed Meat · Intervention Types: Other
Typical Healthy Eating Index Diet with Minimally Processed Meat
Other
Experimental Group · 1 Intervention: Typical Healthy Eating Index Diet with Minimally Processed Meat · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at the beginning and end of diet period 1 (week 1 and week 4), diet period 2 (week 5 and week 9), diet period 3 (week 10 and week 14), and diet period 4 (week 15 and week 19).

Who is running the clinical trial?

National Cattlemen's Beef AssociationOTHER
22 Previous Clinical Trials
1,016 Total Patients Enrolled
2 Trials studying Healthy Subjects (HS)
107 Patients Enrolled for Healthy Subjects (HS)
USDA Beltsville Human Nutrition Research CenterLead Sponsor
54 Previous Clinical Trials
5,200 Total Patients Enrolled
18 Trials studying Healthy Subjects (HS)
523 Patients Enrolled for Healthy Subjects (HS)
David J. Baer, PhDPrincipal InvestigatorUSDA Beltsville Human Nutrition Research Center
Janet A. Novotny, PhDPrincipal InvestigatorUSDA Beltsville Human Nutrition Research Center

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: November 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.