Controlled Clinical Study to Determine Novel Health Benefits of Cheese Consumption
Controlled Feeding Study to Show Effects of Manipulating Carbohydrate and Cheese on Health Markers In Individuals With Metabolic Syndrome
2 other identifiers
interventional
16
1 country
1
Brief Summary
To determine the effects of high cheese diets varying in carbohydrate content on markers of disease risk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 25, 2016
CompletedFirst Posted
Study publicly available on registry
September 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 28, 2019
August 1, 2019
2.6 years
February 25, 2016
August 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Plasma Fatty Acid Composition and Lipoprotein Analysis
Blood analysis for Fatty Acid Composition and Lipoproteins will by conducted by Lipid Technologies and Quest Diagnostics, respectively.
Through study completion, an average of 2 years.
Secondary Outcomes (3)
Change in Body Composition as Assessed by DEXA and MRI
Through study completion, an average of 2 years.
Change in Blood-based Inflammation Markers
Through study completion, an average of 2 years.
Change in Blood Metabolite Profiles
Through study completion, an average of 2 years.
Study Arms (4)
High Carbohydrate No Cheese
EXPERIMENTALIntervention: Nutritional and Dietary Manipulation. This arm will be provided food with an approximate macronutrient breakdown of: 55% CHO, 20% PRO and 25% fat with \~6oz Cheese (gouda or cheddar) per day being used as a fat source.
High Carbohydrate High Cheese
EXPERIMENTALIntervention: Nutritional and Dietary Manipulation. This arm will be provided food with an approximate macronutrient breakdown of: 55% CHO, 20% PRO 25% and Fat 25% with \~6oz Cheese (gouda or cheddar) per day being used as a fat source.
Mod. Carbohydrate High Cheese
EXPERIMENTALIntervention: Nutritional and Dietary Manipulation. This arm will be provided food with an approximate macronutrient breakdown of: 30% CHO, 20% PRO and 50% Fat with \~6oz Cheese (gouda or cheddar) per day being used as a fat source.
Low Carbohydrate High Cheese
EXPERIMENTALIntervention: Nutritional and Dietary Manipulation. This arm will be provided food with an approximate macronutrient breakdown of: 10% CHO, 20% PRO and 70% Fat with \~6oz Cheese (gouda or cheddar) per day being used as a fat source.
Interventions
Participants will undertake a controlled feeding intervention. All food will be prepared and delivered to participants by research staff. Participants will be asked to exclusively eat what is provided to them in efforts to control any dietary effects.
Eligibility Criteria
You may qualify if:
- Waist circumference (≥101.6 cm men, ≥88.9 cm women)
- Blood pressure (≥130/85 mm Hg) or current use of antihypertensive medication
- Fasting plasma glucose (≥100 mg/dL)
- Triglycerides (≥150 mg/dL)
- HDL-C (\<40 mg/dL men, \<50 mg/dL women)
You may not qualify if:
- Hypercholesterolemia
- Diabetes
- Liver, kidney or other metabolic or endocrine dysfunction, gastrointestinal disorders
- Regular smokers
- Lactose-intolerant
- Consume excessive amounts of alcohol (\>3 drinks/d)
- Have used cholesterol, diabetic, antibiotic or antifungal medications in the past 3 months
- Women who are pregnant or lactating
- Participants taking any probiotics or supplements known to affect serum lipid levels, inflammation, antioxidant status or the gut microbiota will be asked to discontinue use to allow for washout of any metabolic effects.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Physical Activity and Education Services - PAES
Columbus, Ohio, 43210, United States
Related Publications (1)
Hyde PN, Sapper TN, Crabtree CD, LaFountain RA, Bowling ML, Buga A, Fell B, McSwiney FT, Dickerson RM, Miller VJ, Scandling D, Simonetti OP, Phinney SD, Kraemer WJ, King SA, Krauss RM, Volek JS. Dietary carbohydrate restriction improves metabolic syndrome independent of weight loss. JCI Insight. 2019 Jun 20;4(12):e128308. doi: 10.1172/jci.insight.128308. eCollection 2019 Jun 20.
PMID: 31217353DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeff Volek, PhD
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 25, 2016
First Posted
September 29, 2016
Study Start
September 1, 2015
Primary Completion
April 1, 2018
Study Completion
December 1, 2018
Last Updated
August 28, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
Final results will be published via peer-review process.