Fruit Juice for Blood Sugar Response

Overseen By Kristen S Smith, PhD, RD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ocean Spray Cranberries, Inc.

Must not be taking: Antihypertensives, Thyroid hormones, Carbohydrate metabolism

Disqualifiers: Cardiac, Renal, Hepatic, Endocrine, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6-12 weeks

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different fruit juices affect blood sugar levels after eating. Participants will try six different juices in a specific order, each followed by a short break. The study seeks individuals with stable blood sugar levels, who are non-smokers, and have maintained a steady diet and weight in recent months. Participation will help researchers understand how fruit juices impact blood sugar, potentially leading to better dietary recommendations. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance dietary guidance for everyone.

Will I have to stop taking my current medications?

The trial requires you to maintain your current medications as long as they do not interfere with the study outcomes. If you have recently started or changed the dose of certain medications like antihypertensives or thyroid hormones, you may not be eligible.

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

A previous study showed that 100% fruit juice has a neutral effect on blood sugar levels, meaning it didn't significantly affect fasting blood glucose. Another study found that 100% fruit juice did not increase the risk of developing type 2 diabetes.

Research also suggests that drinking orange juice can reduce blood sugar spikes after meals compared to other drinks with the same calories. Overall, several studies found that fruit juice did not significantly impact blood sugar or insulin levels.

These findings suggest that 100% fruit juice is generally well-tolerated regarding its effects on blood sugar. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using fruit juice for managing blood sugar levels because it offers a natural alternative to traditional medications like insulin and oral hypoglycemics. Unlike standard treatments, which often involve synthetic drugs, fruit juice may provide a more holistic approach with fewer side effects. Additionally, this method could offer a convenient and enjoyable way for individuals to manage their blood sugar, potentially improving adherence to treatment. By exploring the potential benefits of different fruit juices, this approach might uncover unique properties within fruits that could help regulate blood sugar more effectively.

What evidence suggests that this trial's treatments could be effective for blood sugar response?

This trial will evaluate the effects of different fruit juice products on blood sugar response. Studies have shown that drinking 100% fruit juice doesn't significantly impact blood sugar levels in the short term. Research has found no major changes in blood sugar or insulin levels after consuming 100% fruit juice. One study found that orange juice might help reduce blood sugar spikes when consumed with meals high in fat and carbs. However, other research suggests that juices not made from 100% fruit could increase the risk of developing type 2 diabetes. Overall, the effect of fruit juice on blood sugar can vary, so it's important to consider the type of juice consumed. Participants in this trial will receive each of the six study products sequentially to assess their individual effects. ^{1 2 3 4 6}

Who Is on the Research Team?

Elizabeth Antoo, MD

Principal Investigator

Biofortis Innovation Services

Are You a Good Fit for This Trial?

This trial is for non-smokers aged 18-45 with normal fasting blood sugar, BMI of 18.5-30, not using tobacco/nicotine or certain supplements that affect carbohydrate metabolism. Participants must avoid high-polyphenol foods and alcohol before visits and maintain their usual diet and physical activity.

Inclusion Criteria

Fasting capillary glucose ≤110 mg/dL at Visit 1

Willing to avoid consuming high-polyphenol containing foods for 48 hours prior to each test visit

Willing to abstain from alcohol consumption for 24 hours prior to each study visit

Exclusion Criteria

I haven't taken drugs or supplements that affect blood sugar in the last 30 days.

I haven't changed my thyroid medication in the last 30 days.

Known allergy or sensitivity to any ingredients or potential allergens contained in the study beverages

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive each of the 6 study products sequentially in a cross-over design, with a 3-7-day wash-out period between products

6-12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for postprandial responses to fruit juices

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fruit Juice

Trial Overview

The study tests how different fruit juices (Beverage 1 to Beverage 6) affect blood sugar levels after consumption. It aims to understand the body's response to these beverages in individuals without diabetes.

How Is the Trial Designed?

Group I: Third product order: order not stated to protect study blinding Experimental Treatment 6 Interventions

Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence.

Group II: Sixth product order: order not stated to protect study blinding Experimental Treatment 6 Interventions

Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence.

Group III: Second product order: order not stated to protect study blinding Experimental Treatment 6 Interventions

Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence.

Group IV: Fourth product order: order not stated to protect study blinding Experimental Treatment 6 Interventions

Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence.

Group V: First product order: order not stated to protect study blinding Experimental Treatment 6 Interventions

Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence.

Group VI: Fifth product order: order not stated to protect study blinding Experimental Treatment 6 Interventions

Participant will receive each of the 6 study products sequentially in a cross-over design, consuming one study product for one visit, followed by 3-7-day wash-out period before beginning the next product in the sequence.

Who Is Running the Clinical Trial?

Ocean Spray Cranberries, Inc.

Lead Sponsor

Trials

7

Recruited

520+

Biofortis Innovation Services

Industry Sponsor

Citations

1.

amjmed.com

amjmed.com/article/S0002-9343(25)00303-1/fulltext

Consumption of Fruit Juice and Risk of Type 2 Diabetes ...

The consumption of non-100% fruit juice increased the risk of type 2 diabetes mellitus, while there was no association between the consumption of 100% fruit ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5736636/

100 % Fruit juice and measures of glucose control ...

Results from this meta-analysis of eighteen RCT show no significant effect of 100 % fruit juice on fasting blood glucose, fasting blood insulin, ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S092422442100412X

Effect of citrus fruit and juice consumption on risk ...

Orange juice ingestion along with HFHC significantly reduced the blood glucose responses compared to the isocaloric group. Despite the inherent high sugar ...

4.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0095323

Effect of Fruit Juice on Glucose Control and Insulin Sensitivity ...

In this meta-analysis study, we found that fruit juice had no significant effects on fasting glucose and insulin concentrations.

5.

frontiersin.org

frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2023.1174545/full

Effect of fruit on glucose control in diabetes mellitus: a meta ...

Our meta-analysis showed that fruit consumption significantly reduced fasting blood glucose concentrations but had no significant effect on ...

6.

labmanager.com

labmanager.com/new-research-finds-drinking-100-percent-fruit-juice-does-not-affect-blood-sugar-levels-5382

New Research Finds Drinking 100 Percent Fruit Juice ...

New Research Finds Drinking 100 Percent Fruit Juice Does Not Affect Blood Sugar Levels · The findings are consistent with previous research ...