Ketogenic Diet Health and Longevity

NCT05939011 | Completed DMC

• 1 other identifier: STUDY147643
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ketogenic Dieting; Ketoses, Metabolic; Ketosis

Keywords

ketogenic; well-formulated ketogenic diet; keto

Outcome Measures

Primary Outcomes (6)

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

  Measures of tissue distribution

  Baseline, 8 Week

• Changes in Waist Circumference (WC)

  Waist circumference (cm)

  Baseline, 4 Week, 8 Week

• Changes in Body Mass Index (BMI)

  Ratio of height and weight in kg/m\^2

  Baseline, 4 Week, 8 Week

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

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

  Baseline, 4 Week, 8 Week

• Changes in Advanced Lipid Panel

  Baseline, 8 Week

• Changes in Inflammation

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

  Baseline, 8 Week

Secondary Outcomes (2)

• Changes in transcriptomic sequencing pathways

  Baseline, 8 weeks

• Gut microbial changes

  Baseline, 8 weeks

Study Arms (1)

Well-formulated ketogenic diet (WFKD)

EXPERIMENTAL

The researchers aim to enroll 20 healthy adults recruited from Kansas City and surrounding areas for an 8-week WFKD diet intervention. Study personnel will obtain baseline (week 0), mid-point (week 4), and end-of-study (8 weeks) blood samples, anthropometrics, and dietary intake data. Fecal microbiome samples and dual energy x-ray absorptiometry (DXA) are collected at baseline and 8-weeks. Blood samples collected at baseline and 8-week visits will be measured for metabolic biomarkers, inflammatory biomarkers, and RNA. The blood sample collected at the 4-week visit will include glucose, insulin, insulin resistance, and beta-hydroxybutyrate to track diet adherence and adjust the diet as needed.

Behavioral: Well-formulated Ketogenic Diet

Interventions

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.

Well-formulated ketogenic diet (WFKD)

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• University of California, Davis: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66208, United States

Location

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Debra K Sullivan, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair, Dietetics and Nutrition

Model Details: Single-arm, pilot clinical trial

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: July 11, 2023
• Study Start: April 8, 2022
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)