Low Fat vs High Fat Diet for Prediabetes

(DGENE-NAFLD Trial)

Overseen By André Tremblay, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must not be taking: Steroids, Beta blockers, Thiazides, others

Disqualifiers: Cardiovascular disease, Mental instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different diets impact liver health in individuals with prediabetes, a condition where blood sugar levels are elevated but not yet high enough for a diabetes diagnosis. Participants will follow either a high-fat or low-fat diet for three days, with all meals provided to ensure consistency. The research examines how replacing certain carbohydrates with healthier fats affects liver fat and function. Individuals with a larger waistline and slightly elevated blood sugar and insulin levels may be suitable for this study. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research on diet and liver health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that affect lipoprotein metabolism, like steroids or beta blockers.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both high-fat and low-fat diets have been studied for safety in people with prediabetes. Studies have found that a high-fat diet, rich in healthy fats like those in olive oil and avocados, can lower the risk of developing isolated impaired fasting glucose, a type of prediabetes. This indicates that consuming these fats is generally safe.

For the low-fat diet, research has linked it to longer life spans, suggesting that people on low-fat diets tend to live longer, which is a positive indicator of safety. Both diet types appear safe for those with prediabetes, with studies reporting no major negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about testing dietary approaches for prediabetes because they may offer a more natural and accessible way to manage this condition compared to traditional methods like medication. The high fat and low fat diets both focus on altering macronutrient intake, which could have a direct impact on blood sugar levels and insulin sensitivity. Unlike standard treatments that often involve drugs, these diets provide a potential lifestyle-based intervention that could empower individuals to manage prediabetes through everyday food choices. Additionally, these dietary approaches might show results in just a few days, offering quicker insights into their effectiveness.

What evidence suggests that this trial's diets could be effective for prediabetes?

This trial will compare the effects of a high-fat diet with a low-fat diet for individuals with prediabetes. Research has shown that consuming a diet high in unsaturated fats, such as those in olive oil, might reduce the risk of developing high blood sugar, a precursor to prediabetes. Studies have found that these fats can help individuals with prediabetes manage their blood sugar more effectively. Conversely, low-fat diets are linked to lower body weight and improved cholesterol levels. They might also help reduce blood sugar over time, promoting better overall health. Both diet types can be beneficial, but their effects may vary based on a person's specific health needs. ^{1 2 4 6 7}

Who Is on the Research Team?

Patrick Couture, MD, PhD

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with pre-diabetes, indicated by specific blood sugar and insulin levels. Participants must have a waist size over set thresholds, elevated triglycerides, be non-smokers, and in general good health without severe kidney or coagulation issues. They should not have HIV, uncontrolled endocrine diseases, recent investigational drug use, mental instability or substance abuse history.

Inclusion Criteria

Subjects must be willing to give written informed consent and able to adhere to the diet schedule and visit schedule

I am generally healthy with normal kidney function and blood clotting.

Your blood has high levels of triglycerides (a type of fat) during the screening visit.

Exclusion Criteria

I am not diabetic and do not have uncontrolled metabolic diseases affecting my blood fats.

Patients who have used any investigational drug within 30 days of the first clinic visit will be excluded

My kidney function is normal, without any significant disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Dietary Intervention

Participants consume a controlled diet with either high or low fat content for 3 days

3 days

Follow-up

Participants are monitored for changes in hepatic gene expression and lipid composition

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High fat diet
• Low fat diet

Trial Overview The study tests the effects of a low carbohydrate/high unsaturated fatty acid diet on liver fat composition and gene expression in pre-diabetic individuals. All meals are provided under controlled conditions to maintain body weight while assessing dietary impact on hepatic health.

How Is the Trial Designed?

Group I: Low fat diet Experimental Treatment 2 Interventions

During 3 days, subjects eat a diet low in fat (percent of total caloric intake: 15.0% from proteins; 65.0% from carbohydrates; 20.0% from fat: 4.0% from saturated fat; 10.0% from monounsaturated fat; 6.0% from polyunsaturated fat

Group II: High fat diet Experimental Treatment 2 Interventions

During 3 days, subjects eat a diet high in fat (percent of total caloric intake: 15.0% from proteins; 45.0% from carbohydrates; 40.0% from fat: 8.0% from saturated fat; 22.0% from monounsaturated fat; 10.0% from polyunsaturated fat

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Published Research Related to This Trial

There is no evidence that increased fat intake is responsible for the rise in obesity, and diets with 30-35% of energy from fat can actually promote weight loss.

High-carbohydrate diets, especially those with a high glycaemic index, can lead to insulin resistance, but this can be countered by increased physical activity, highlighting the importance of exercise in managing diet-related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High- versus low-fat diets in human diseases. Sanders, TA.[2019]

Low-carbohydrate diets (LCDs) significantly reduced HbA1c levels by 0.35% and led to greater body weight loss compared to low-fat diets (LFDs) in type 2 diabetes patients, based on a review of 12 randomized controlled trials involving 761 participants.

LCDs also improved cardiovascular risk factors by lowering triglycerides and increasing HDL cholesterol, with these benefits lasting up to 2 years, although the weight loss effects diminished after 2 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Efficacy and Safety of Low-Carbohydrate Diets with Low-Fat Diets for Type 2 Diabetes Mellitus Patients: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Li, S., Ding, L., Xiao, X.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7103851/

Effects of the low carbohydrate, high fat diet on glycemic ... Our results demonstrate that participants who followed the low carbohydrate, a high fat diet had superior glycemic reduction, as measured by A1 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10261444/

Impact of dietary fat composition on prediabetes: a 12-year ... A moderately high intake of dietary MUFA (10–15 % of total daily energy) was associated with a 10 % reduced risk of isolated IFG incidence, while a high intake ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1043661825003391

The efficacy of dietary interventions for prediabetes ... While several dietary interventions that improve cardiometabolic health of individuals with prediabetes were identified, the credibility of evidence is weak.

4. diabetesjournals.org diabetesjournals.org/diabetes/article/70/12/2785/139070/Different-Effects-of-Lifestyle-Intervention-in

Different Effects of Lifestyle Intervention in High- and Low-Risk ... The changes of liver fat content and insulin sensitivity were significantly associated with improvement of glucose tolerance, independent of ...

5. medrxiv.org medrxiv.org/content/10.1101/2022.05.30.22275766v1.full-text

A systematic review and Bayesian network meta-analysis ... High-fat diets without carbohydrate restriction did not show any beneficial effects compared to control diets. Severe heterogeneity and ...

6. nature.com nature.com/articles/s41598-020-60153-9

Association between Dietary Quality and Prediabetes ... Our results indicated that people who were obese (BMI) and had an unfavourable dietary quality had a high risk of prediabetes, and abdominal ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522000223

Associations of lower-carbohydrate and lower-fat diets with ... In a nationally representative sample of US adults with prediabetes, healthy LCD and LFD scores were significantly associated with a lower risk of mortality, ...