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Ketogenic Diet Variations for Type 2 Diabetes and Obesity (KETO-IM Trial)

N/A

Recruiting

Led By Catherine Chan, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Familial hypercholesterolemia or hypertriglyceridemia

People on dialysis or recommended to follow a low-protein diet (based on glomerular filtration rate)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the effects of two KETO diets and a low-fat diet on CVD risk, inflammation, and immune function in people at risk of or with type 2 diabetes. Results will be measured at 3 and 6 months.

Who is the study for?

This trial is for adults with obesity or overweight and HbA1C levels at or above 5.7%, indicating high blood sugar, which can be a sign of prediabetes or diabetes. It's not suitable for individuals with certain cholesterol or triglyceride disorders, those undergoing menopause, on dialysis, transitioning transgender individuals, pregnant women, or anyone whose diet wouldn't allow them to follow the study's nutritional guidelines.

What is being tested?

The study is testing three diets: a ketogenic diet supplemented with saturated fat (Keto-SAT), a ketogenic diet supplemented with canola oil (Keto-CAN), and a low-fat diet (LFD). Participants will be randomly assigned to one of these diets to see how they affect heart disease risk factors like cholesterol and blood sugar levels as well as inflammation and immune function over periods of 3 and 6 months.

What are the potential side effects?

Potential side effects may include changes in cholesterol levels due to different fat sources in the diets. The keto diets might cause digestive issues like constipation due to lower fiber intake. There could also be fatigue during initial adaptation to ketosis.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a family history of high cholesterol or high triglycerides.

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I am on dialysis or advised to eat a low-protein diet due to kidney function.

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I am going through menopause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effect of diets on LDL-cholesterol levels by comparing groups at 3 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 3 months).

Effect of diets on LDL-cholesterol levels by comparing groups at 6 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 6 months).

Effect of diets on plasma triglycerides levels by comparing groups at 3 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 3 months).

+1 more

Secondary study objectives

Effect of diets on ApoB100 levels by comparing groups at 3 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 3 months).

Effect of diets on ApoB100 levels by comparing groups at 6 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 6 months).

Effect of diets on blood glucose levels by comparing groups at 3 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 3 months).

+9 more

Other study objectives

Adherence to diet interventions using 24-hour dietary assessment tool

Change in fatty acid composition to confirm adherence to the diets at 3 months

Change in fatty acid composition to confirm adherence to the diets at 6 months