Whole Fruit for Type 2 Diabetes

(FRUIT2 Trial)

KJ
Overseen ByKathleen Johnson Research Project Manager, MPH, RD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Harvard School of Public Health (HSPH)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how consuming a large amount of whole fruit affects blood sugar control, liver health, and heart health in adults with type 2 diabetes who do not use insulin. Participants will follow a diet where half of their calories come from whole fruit. Ideal candidates have type 2 diabetes, are not on insulin, and maintain a stable weight. The goal is to determine if a fruit-rich diet can improve health markers in this group. As an unphased trial, participants contribute to valuable research that could lead to new dietary recommendations for managing type 2 diabetes.

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've changed the dosage of a chronic medication that may affect the study in the past 3 months.

What prior data suggests that consuming whole fruit is safe for adults with type 2 diabetes?

Research has shown that eating whole fruits is generally safe and might even help with type 2 diabetes. Studies have found that people who consume more whole fruits, such as blueberries, grapes, and apples, have a lower risk of developing type 2 diabetes. This suggests that whole fruits can be part of a healthy diet without causing harm.

No evidence indicates serious side effects from eating whole fruits. In fact, whole fruits are linked to better health. For example, individuals who eat two servings of fruit a day have a 36% lower chance of developing type 2 diabetes compared to those who eat less fruit. Thus, eating whole fruit is considered safe and well-tolerated.12345

Why are researchers excited about this trial?

Unlike the usual diabetes treatments that often involve medications like metformin or insulin injections, this approach is unique because it focuses on consuming whole fruits as a significant part of the diet. Whole fruits are packed with natural fibers, vitamins, and antioxidants, which can help regulate blood sugar levels and improve overall health without the side effects associated with synthetic drugs. Researchers are excited about this treatment because it offers a more natural, potentially safer way to manage Type 2 diabetes while also encouraging healthier eating habits.

What evidence suggests that consuming whole fruit might be an effective treatment for type 2 diabetes?

Research shows that eating whole fruits can help manage type 2 diabetes. In this trial, participants will consume whole fruit, making up 50% of their total calories. One study found that people who ate more whole fruits were 36% less likely to develop diabetes after five years. Another study demonstrated that adding whole fruits to a Mediterranean-style diet helped control blood sugar and lower blood pressure. A review of five studies found that eating fruit significantly reduced HbA1c levels, a measure of blood sugar control. Additionally, observational studies indicate that eating an extra serving of fruit each day can lower the risk of death by 17% for those with type 2 diabetes.26789

Who Is on the Research Team?

CM

Courtney M Peterson

Principal Investigator

Harvard School of Public Health (HSPH)

Are You a Good Fit for This Trial?

This trial is for adults over 18 with type 2 diabetes, specifically those who have an HbA1c level between 6.5-12.0% and a fasting C-peptide level ≥0.5 ng/ml, indicating functioning beta cells. It's not for insulin-treated patients or those with other exclusions not listed.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.
I am 18 years old or older.
My HbA1c level is between 6.5% and 12.0%.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume a large amount of whole fruit, constituting 50% of total calories, for 17 weeks

17 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Whole Fruit

Trial Overview

The study is looking at how eating whole fruit affects blood sugar control, liver fat levels, and heart health in people with type 2 diabetes who don't use insulin.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Whole FruitExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Harvard School of Public Health (HSPH)

Lead Sponsor

Trials
283
Recruited
17,030,000+

Citations

Fruit consumption and risk of type 2 diabetes - PMC - NIH

Greater consumption of specific whole fruits, particularly blueberries, grapes, and apples, was significantly associated with a lower risk of type 2 diabetes, ...

Effects of Whole Fruit on Blood Sugar in People With Type ...

The investigators previously found that a whole-fruit-rich, Mediterranean-style diet improved blood sugar control and blood pressure in patients ...

Nutrition Research

Observational studies in adults with T2D find that each additional daily serving of fruit lowers the risk of overall mortality by 17% [52] and those consuming ...

People who eat a healthy diet including whole fruits may ...

They found participants who ate more whole fruits had 36 percent lower odds of having diabetes at five years. The researchers found an ...

A meta-analysis of available data of the effects of selected ...

Five RCTs involving 245 participants were included. Fruit consumption significantly reduced HbA1c levels (MD, −0.33 %; 95 % CI, −0.54 % to −0.11 %; I² = 44 %).

Whole fresh fruit intake and risk of incident diabetes in ... - PMC

Overall, we identified a linear and dose-dependent inverse association between dietary whole fresh fruit intake and risk of incident T2D.

Fruit consumption and risk of type 2 diabetes: results from ...

Greater consumption of specific whole fruits, particularly blueberries, grapes, and apples, is significantly associated with a lower risk of type 2 diabetes.

People who eat a healthy diet including whole fruits may ...

A new study finds people who consume two servings of fruit per day have 36 percent lower odds of developing type 2 diabetes than those who consume less than ...

Consumption of fruit juice and risk of type 2 diabetes mellitus

The consumption of non-100% fruit juice increased the risk of type 2 diabetes mellitus. Unlike whole fruit consumption, 100% fruit juice had no beneficial ...