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Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources

NCT05681468 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2026-01-08

No results posted yet for this study

Summary

The goal of this clinical trial is to compare a healthy KETO diet supplemented with canola oil (KETO-Can) compared to a traditional KETO diet high in saturated fat (KETO-Sat) and low-fat diet (LFD) in adults at high risk of or diagnosed with type 2 diabetes. The main question\[s\] it aims to answer are:

* Effects on CVD risk factors (plasma cholesterol, TG, ApoB100, glucose, insulin and HbA1C).
* Effects on systemic inflammation and immune function.
* Adherence to interventions.

Participants will be randomized into 1 of the dietary treatments during which they will follow a Keto or a low-fat diet.

Comparisons among groups at 3 and 6 months of intervention will be conducted.

Conditions

  • PreDiabetes
  • Diabetes Mellitus, Type 2
  • Overweight and Obesity

Interventions

OTHER

Keto-SAT

Nutrition counselling focused on Keto diet (saturated fat). 10% TE as carbohydrate (mainly from vegetables and whole grain products), protein between 20-30% TE and fat between 60-70%.

OTHER

Keto-CAN

Nutrition counselling focused on Keto diet (unsaturated fat). 10% TE as carbohydrate (mainly from vegetables and whole grain products), protein between 20-30% TE and fat between 60-70%.

OTHER

LFD

Nutrition counselling focused on low-fat diet. 30% total energy (TE) as fat, 50% TE as carbohydrates (primarily whole grains) and 17-20% TE protein (mainly lean sources).

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Catherine Chan, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05681468 on ClinicalTrials.gov