Dietary Fatty Acid Profiles for Type 2 Diabetes

(METAc Trial)

Overseen By Alain Veilleux, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must not be taking: Omega-3, Vitamins, Probiotics, others

Disqualifiers: Intestinal pathologies, Alcohol, Tobacco, others

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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires you to stop taking dietary supplements like vitamins and probiotics at least 2 weeks before starting. It doesn't specify about other medications, so you might not need to stop them, but it's best to check with the trial organizers.

What data supports the effectiveness of the treatment Dietary Fatty Acid Profiles for Type 2 Diabetes?

Research shows that nutrition therapy, including dietary interventions, can effectively help manage blood sugar levels, cholesterol, and blood pressure in people with type 2 diabetes. Additionally, diets high in monounsaturated fats and omega-3 fatty acids have been found to improve metabolic control in these patients. ^{1 2 3 4 5}

Is the dietary fatty acid profile treatment safe for humans?

Research on dietary fatty acids, including omega-3 fatty acids like EPA and DHA, suggests they are generally safe for people with type 2 diabetes, as they have been studied for their effects on heart health and mortality without significant safety concerns. ^{6 7 8 9 10}

How is the dietary fatty acid profile treatment different from other treatments for type 2 diabetes?

This treatment focuses on adjusting the types of fats in the diet, such as increasing omega-3 fatty acids, which may influence metabolic control and insulin sensitivity in type 2 diabetes. Unlike medications, this approach uses dietary changes to potentially improve health outcomes. ^{9 11 12 13 14}

What is the purpose of this trial?

The proposed project mainly aims to investigate the microbial processes leading to dietary metabolites production, independently of long-term microbiota adaptation to the diet, by measuring the microbiota-derived metabolite production from a meal sequence rich in saturated fatty acids (SFA) or the same meals but rich in polyunsaturated fatty acids (PUFA) in individuals with or without obesity and Type 2 diabetes (T2D)

Research Team

Alain Veilleux, PhD

Principal Investigator

Laval University

Eligibility Criteria

This trial is for men and women aged 45-65, with a BMI of 20-35 kg/m², who are generally healthy and have a moderate diet quality. They must understand French and have internet access. It's not for smokers, heavy drinkers, recent antibiotic users, those on omega-3 supplements or with significant weight changes recently.

Inclusion Criteria

Basic understanding of written French

Basic understanding of written French ;

The number of times you go to the bathroom each day.

Exclusion Criteria

You take omega-3 dietary supplements.

You currently use tobacco and cannabis.

I have type 1 diabetes or use insulin for my diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Run-in Diet

Participants undergo a 3-day run-in diet to standardize conditions before the main dietary interventions

3 days

Dietary Intervention

Participants follow a 2-day diet rich in polyunsaturated fatty acids (PUFA) and a 2-day diet rich in saturated fatty acids (SFA)

4 days

Follow-up

Participants are monitored for fasting and postprandial lipid metabolite production and gut microbiota composition

7 days

Treatment Details

Interventions

• Nutritional intervention

Trial Overview The study looks at how different types of fats in meals (saturated vs. polyunsaturated fatty acids) affect the production of certain metabolites by gut bacteria in people with/without obesity and Type 2 diabetes.

Participant Groups

Group I: Single Experimental Treatment 1 Intervention

All participating subjects will undergo 3 feeding phases : 3 days of a run-in diet, 2 days of a polyunsaturated fatty acid (PUFA) diet and 2 days of a saturated fatty acid (SFA) diet.

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Findings from Research

Newly diagnosed type 2 diabetes patients initially have an unfavorable fat consumption profile, with 40.9% of their energy intake from fat, including high levels of saturated fatty acids compared to the general population.

After dietary consultation, patients significantly improved their fat intake within 8 weeks, maintaining healthier levels for 4 years, although they still did not fully meet recommendations for total and saturated fat consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fat intake in patients newly diagnosed with type 2 diabetes: a 4-year follow-up study in general practice. van de Laar, FA., van de Lisdonk, EH., Lucassen, PL., et al.[2018]

Strong evidence indicates that the total amount of carbohydrates consumed is more crucial for managing diabetes than the specific type of carbohydrate, highlighting the importance of portion control and meal planning.

Nutrition therapy is effective in achieving treatment goals for blood sugar, lipids, and blood pressure in individuals with type 2 diabetes, and ongoing monitoring is essential to evaluate the effectiveness of lifestyle changes and medication adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prioritizing diabetes nutrition recommendations based on evidence. Franz, MJ.[2015]

A study involving 124 overweight/obese participants with type 2 diabetes showed that both high-monounsaturated fatty acid (MUFA) and high-carbohydrate (CHO) diets resulted in similar weight loss and improvements in glycemic control over one year.

Both diets led to comparable benefits in body composition and cardiovascular risk factors, suggesting that high-MUFA diets can be a viable alternative to traditional high-CHO diets for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year comparison of a high-monounsaturated fat diet with a high-carbohydrate diet in type 2 diabetes. Brehm, BJ., Lattin, BL., Summer, SS., et al.[2022]

A systematic review of 83 randomized controlled trials involving over 58,000 participants found that increasing long chain omega-3 fatty acids had little to no effect on the diagnosis of diabetes or glucose metabolism, suggesting they may not be effective for diabetes prevention or treatment.

While some evidence indicated that high doses of long chain omega-3 (above 4.4 g/d) could potentially lead to negative outcomes, the overall findings suggest that omega-3, omega-6, and total polyunsaturated fatty acids do not significantly impact diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3, omega-6, and total dietary polyunsaturated fat for prevention and treatment of type 2 diabetes mellitus: systematic review and meta-analysis of randomised controlled trials. Brown, TJ., Brainard, J., Song, F., et al.[2022]

A 24-week dietary intervention with increased protein and omega-3 fatty acids significantly improved glycemic control in type 2 diabetes patients, as shown by a reduction in HbA1c levels from 63±11mmol/mol to 56±12mmol/mol.

The intervention also led to a significant decrease in waist circumference and systemic inflammation, indicating potential benefits for overall metabolic health in overweight or obese individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A protein-enriched low glycemic index diet with omega-3 polyunsaturated fatty acid supplementation exerts beneficial effects on metabolic control in type 2 diabetes. Moosheer, SM., Waldschütz, W., Itariu, BK., et al.[2022]

In a study of 11,264 participants with type 2 diabetes over several decades, higher intake of polyunsaturated fatty acids (PUFAs) was linked to lower cardiovascular disease mortality, suggesting that the type of dietary fat consumed is crucial for heart health.

Replacing saturated fats with PUFAs or linoleic acid could lead to significant reductions in both cardiovascular disease and total mortality, emphasizing the importance of dietary fat quality in managing health outcomes for individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fats and mortality among patients with type 2 diabetes: analysis in two population based cohort studies. Jiao, J., Liu, G., Shin, HJ., et al.[2022]

In a study of 2,397 participants with type 2 diabetes, the average intake of marine omega-3 fatty acids (mO-3FA) was low at 162 mg/day, but higher intake was linked to lower triglyceride levels, suggesting a beneficial effect on lipid control.

After a year of intensive lifestyle intervention aimed at weight loss, participants showed a significant decrease in mO-3FA intake, highlighting the need to explore the benefits of increasing omega-3 consumption in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marine omega-3 fatty acid intake: associations with cardiometabolic risk and response to weight loss intervention in the Look AHEAD (Action for Health in Diabetes) study. Belalcazar, LM., Reboussin, DM., Haffner, SM., et al.[2021]

In a study of 227 patients with type 2 diabetes followed for an average of 4.6 years, a higher intake of polyunsaturated fatty acids was found to significantly reduce the risk of cardiac events, with a hazard ratio of 0.31, indicating a protective effect.

Specifically, a high intake of alpha-linolenic acid (over 1.25% of total energy) was associated with a 42% lower risk of cardiac events, suggesting that dietary fat composition plays a crucial role in heart health for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fat composition and cardiac events in patients with type 2 diabetes. dos Santos, AL., Weiss, T., Duarte, CK., et al.[2022]

A systematic review of 46 randomized clinical trials involving 4991 patients with type 2 diabetes found that omega-3 polyunsaturated fatty acids (n-3 PUFAs) significantly improved several cardiovascular risk factors, including total cholesterol, triglycerides, and hemoglobin A1c levels.

The study indicates that while n-3 PUFAs positively affect cardiovascular risk markers, they do not significantly impact renal function or insulin resistance, suggesting a targeted benefit for lipid profiles in type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of omega-3 fatty acids in type 2 diabetes: A systematic review and meta-analysis. Xiao, Y., Zhang, Q., Liao, X., et al.[2022]

In a study of 2,991 adults with diabetes over a mean follow-up of 9.4 years, higher intakes of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) were linked to significantly lower risks of mortality from cardiovascular disease (CVD) and coronary heart disease (CHD).

Specifically, those in the highest intake quartile of EPA had a 45% lower risk of CHD and CVD mortality compared to the lowest quartile, while DHA intake showed similar protective trends, highlighting the potential health benefits of these omega-3 fatty acids for individuals with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of eicosapentaenoic acid and docosahexaenoic acid intakes with cardiovascular and all-cause mortality in patients with diabetes: Result from National Health and Nutrition Examination Survey 1999-2008. Huang, N., Wang, F., Li, S., et al.[2023]

In a study of 54 patients with Type 2 Diabetes Mellitus, higher intake of saturated fatty acids and total fat was linked to increased fasting blood glucose levels and insulin resistance, indicating that the quality of dietary fats can significantly impact metabolic control.

The percentage of calories from fat was found to predict a substantial portion of variability in very low-density lipoprotein cholesterol (c-VLDL), suggesting that dietary fat composition plays a crucial role in lipid profiles and overall metabolic health in individuals with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[IMPACT OF DIETARY FATTY ACIDS ON LIPID PROFILE, INSULIN SENSITIVITY AND FUNCTIONALITY OF PANCREATIC β CELLS IN TYPE 2 DIABETIC SUBJECTS]. Sambra Vásquez, V., Rojas Moncada, P., Basfi-Fer, K., et al.[2017]

A study of 53 obese Dutch individuals with non-insulin-dependent diabetes mellitus (NIDDM) found that analyzing a single adipose tissue biopsy can effectively reflect long-term dietary intake of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

The correlation between dietary intake of EPA and its levels in adipose tissue was strong (0.76 for men, 0.57 for women), indicating that adipose tissue analysis can serve as a reliable indicator of long-term fatty acid consumption, reducing the need for frequent dietary assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids in adipose tissue of obese patients with non-insulin-dependent diabetes mellitus reflect long-term dietary intake of eicosapentaenoic and docosahexaenoic acid. Popp-Snijders, C., Blonk, MC.[2018]

A meta-analysis of 24 studies with 1,460 participants found that diets high in cis-monounsaturated fatty acids (MUFA) significantly reduced fasting plasma glucose, triglycerides, body weight, and systolic blood pressure in patients with type 2 diabetes compared to high-carbohydrate diets.

When comparing high-MUFA diets to high-polyunsaturated fatty acid (PUFA) diets, there was also a significant reduction in fasting plasma glucose, suggesting that high-MUFA diets can effectively improve metabolic risk factors in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Effects of Monounsaturated Fatty Acid-Enriched Diets Compared With Carbohydrate or Polyunsaturated Fatty Acid-Enriched Diets in Patients With Type 2 Diabetes: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Qian, F., Korat, AA., Malik, V., et al.[2022]

In a study of 5675 non-diabetic middle-aged participants, saturated fatty acids (SFA) showed a weak inverse association with fasting insulin and insulin resistance markers, suggesting that not all fats are equally harmful regarding type 2 diabetes risk.

Fatty acids from meat sources were positively associated with higher fasting insulin levels and insulin resistance, indicating that the source of fatty acids plays a crucial role in their impact on type 2 diabetes risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatty acid intake and its dietary sources in relation with markers of type 2 diabetes risk: The NEO study. Wanders, AJ., Alssema, M., de Koning, EJ., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Fat intake in patients newly diagnosed with type 2 diabetes: a 4-year follow-up study in general practice. [2018]

2. Italy pubmed.ncbi.nlm.nih.gov

Prioritizing diabetes nutrition recommendations based on evidence. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

One-year comparison of a high-monounsaturated fat diet with a high-carbohydrate diet in type 2 diabetes. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Omega-3, omega-6, and total dietary polyunsaturated fat for prevention and treatment of type 2 diabetes mellitus: systematic review and meta-analysis of randomised controlled trials. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A protein-enriched low glycemic index diet with omega-3 polyunsaturated fatty acid supplementation exerts beneficial effects on metabolic control in type 2 diabetes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Dietary fats and mortality among patients with type 2 diabetes: analysis in two population based cohort studies. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Marine omega-3 fatty acid intake: associations with cardiometabolic risk and response to weight loss intervention in the Look AHEAD (Action for Health in Diabetes) study. [2021]

8. Ireland pubmed.ncbi.nlm.nih.gov

Dietary fat composition and cardiac events in patients with type 2 diabetes. [2022]

9. Scotland pubmed.ncbi.nlm.nih.gov

The effects of omega-3 fatty acids in type 2 diabetes: A systematic review and meta-analysis. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Associations of eicosapentaenoic acid and docosahexaenoic acid intakes with cardiovascular and all-cause mortality in patients with diabetes: Result from National Health and Nutrition Examination Survey 1999-2008. [2023]

11. Spain pubmed.ncbi.nlm.nih.gov

[IMPACT OF DIETARY FATTY ACIDS ON LIPID PROFILE, INSULIN SENSITIVITY AND FUNCTIONALITY OF PANCREATIC β CELLS IN TYPE 2 DIABETIC SUBJECTS]. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids in adipose tissue of obese patients with non-insulin-dependent diabetes mellitus reflect long-term dietary intake of eicosapentaenoic and docosahexaenoic acid. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Metabolic Effects of Monounsaturated Fatty Acid-Enriched Diets Compared With Carbohydrate or Polyunsaturated Fatty Acid-Enriched Diets in Patients With Type 2 Diabetes: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Fatty acid intake and its dietary sources in relation with markers of type 2 diabetes risk: The NEO study. [2018]