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Completed

NCT Number: NCT05939011

Ketogenic Diet Health and Longevity

The goal of this pilot intervention is to learn about how a well-formulated ketogenic diet (WFKD) impacts various health factors in generally healthy adults. The main questions it aims to answer are:

* Establish whether an 8-week isocaloric, WFKD improves body composition and metabolic biomarkers in adults without chronic disease. * Examine changes in transcriptomic sequencing pathways pre- and post-WFKD intervention. * Explore gut microbial changes in adults without chronic disease that consume a WFKD.

Participants will follow a well-formulated ketogenic diet for 8-weeks. Study procedures include:

* Weekly body weight tracking * Daily urinary ketone assessment * Pre/post stool samples for gut microbiota analyses * Pre/post DXA scans * Diet quality tracking through 3-day food records

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Key information

Conditions

Ketogenic Dieting Acid-Base Imbalance Acidosis Ketoses, Metabolic Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66208, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 30 to 55 years
  • Speaks English as primary language
  • BMI 20.0-34.9 kg/m^2

Exclusion criteria

  • Certain medications (statin, blood pressure, thyroid hormone replacement, etc.)
  • Prior medical diagnosis of type 1 or type 2 diabetes mellitus, cancer requiring chemotherapy or radiation therapy within 5 years, cardiac event, GI disorders, traumatic brain injury/multiple concussions, hypertension, dyslipidemia, or any diagnosis deemed ineligible by study team
  • History of renal stones
  • Currently lactating
  • Already following a ketogenic diet
  • Adherence to a specialized diet regimen that disallows compliance
  • Use of tobacco or tobacco replacement products within 1 year

Treatment and study plan

Well-formulated Ketogenic Diet

Behavioral

1:1 ketogenic diet that is focused on intake of high-quality fats (nuts/seeds, fatty fish, avocado) and reduction in processed food.

Primary outcomes

  1. Changes in Body Composition-- dual x-ray absorptiometry (DXA)

    Time frame: Baseline, 8 Week

    Measures of tissue distribution

  2. Changes in Waist Circumference (WC)

    Time frame: Baseline, 4 Week, 8 Week

    Waist circumference (cm)

  3. Changes in Body Mass Index (BMI)

    Time frame: Baseline, 4 Week, 8 Week

    Ratio of height and weight in kg/m^2

  4. Changes in Homeostatic model assessment of Insulin Resistance (HOMA-IR)

    Time frame: Baseline, 4 Week, 8 Week

    Ratio of fasting glucose and fasting insulin with a conversion factor, unitless

  5. Changes in Advanced Lipid Panel

    Time frame: Baseline, 8 Week

  6. Changes in Inflammation

    Time frame: Baseline, 8 Week

    Changes in high sensitivity C-reactive protein (hs-CRP) (mg/L)

Secondary outcomes

  1. Changes in transcriptomic sequencing pathways

    Time frame: Baseline, 8 weeks

    Measured via RNASequencing (RNA-Seq) technique: high-throughput (~25,000 genes) RNAseq using SE100 Illumina (HiSeq) reads

  2. Gut microbial changes

    Time frame: Baseline, 8 weeks

    Taxonomic classification of individual operational taxonomic units (OTU) with 97% similarity and produce an OTU table of all identified taxa across all samples

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • University of California, Davis

Registry information

Official study title

Pilot Investigation of the Ketogenic Diet's Health Effects Through Multi-Omics Assessment

Acronym: KDHL

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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