Whole Foods Diet for Prediabetes

Overseen By Daien Sanchez, MA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University

Must not be taking: Diabetes medications, Weight loss drugs

Disqualifiers: Type 2 diabetes, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a whole foods diet can help adults with prediabetes lower their blood sugar levels and improve overall diet quality for themselves and their children. Participants will follow a special whole foods eating plan for 12 weeks. The trial will assess adherence to the diet and participant satisfaction. It is open to parents with prediabetes who can cook meals at home and have at least one child aged 6-18 living with them in the Greater Nashville, Tennessee area. As an unphased trial, this study offers participants the chance to contribute to valuable research on diet and health.

Will I have to stop taking my current medications?

The trial requires that adults not be taking medications to treat diabetes or promote weight loss. If you are on such medications, you would need to stop taking them to participate.

What prior data suggests that this whole foods diet is safe for prediabetes?

Research shows that a whole foods diet is feasible and acceptable for families at high risk for type 2 diabetes. Studies suggest that adults with prediabetes and their children can follow this diet without issues. Early studies reported no major side effects. Participants typically find the diet enjoyable and easy to maintain, indicating its safety. For those considering joining a clinical trial, this evidence suggests that a whole foods diet could be a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of a whole foods dietary approach as a method to manage prediabetes, which differs from the usual focus on medications or generalized dietary advice. Unlike standard care that often involves medications like metformin or basic dietary guidelines, this approach emphasizes a specific whole foods "dietary pattern" designed to be more sustainable and personalized. The trial aims to investigate if this method can effectively manage blood sugar levels and promote long-term health benefits without relying on medication, which could be a game-changer for lifestyle-based diabetes prevention.

What evidence suggests that a whole foods diet might be an effective treatment for prediabetes?

Research shows that a diet rich in whole foods can lower HbA1c levels, which measure blood sugar control, in adults with prediabetes. In this trial, participants in the Whole Foods Healthy Eating Group will follow a whole foods dietary pattern. Studies have found that this approach may improve blood sugar levels and overall diet quality. Participants who followed a whole foods diet reported high satisfaction and ease of maintenance. While research continues, these early findings suggest that focusing on whole foods could be a promising way to manage prediabetes. ^{3 6 7 8 9}

Who Is on the Research Team?

Nadia M Sneed, PhD, MSN

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

This trial is for adult-child pairs where the adult has prediabetes. They should be willing to follow a whole foods diet without calorie restrictions and participate in surveys or focus groups. The study aims to keep at least 80% of participants until the end and achieve high satisfaction with the diet.

Inclusion Criteria

I have been diagnosed with prediabetes based on recent lab tests.

I can follow a 12-week diet plan that involves cooking at home.

My child can join a 12-week diet program with meals provided.

Exclusion Criteria

Adults with serious mental or neurologic illness, pregnant or nursing, taking specific medications, or living outside Greater Nashville Tennessee

I am an adult managing prediabetes, participating in a weight loss program, or have a history of type 2 diabetes.

I am not between the ages of 25 and 59.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feeding Phase

Participants undergo an intensive 2-week controlled feeding period followed by a 6-week partial feeding period focusing on a whole foods dietary pattern

8 weeks

Weekly check-ins (virtual or in-person)

Maintenance Phase

Participants enter a 4-week 'free-living' period to assess intervention feasibility without food provision or dietetic support

4 weeks

Bi-weekly follow-ups (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Whole Foods for Families

Trial Overview The trial tests if a family-centered, non-calorie restricted whole foods diet can improve adults' HbA1c levels (a diabetes indicator) and enhance overall diet quality for both adults and children over 12 weeks compared to those not following this specific diet.

How Is the Trial Designed?

Group I: Whole Foods Healthy Eating Group (Intervention) Experimental Treatment 1 Intervention

The 12-week whole foods intervention consists of 2 phases. The feeding phase (weeks 1-8) is comprised of an intensive 2-week controlled feeding period followed by a 6-week partial feeding period. This diet intervention will encourage the consumption of a whole foods "dietary pattern". The maintenance phase (weeks 9-12) is a 4-week "free-living" period to assess intervention feasibility without food provision or dietetic support.

Group II: Whole Foods Counseling Group (Control) Active Control 1 Intervention

Participants randomized to the control group will receive dietetic counseling sessions (weeks 1-2) on the 2020-2025 Dietary Guidelines for Americans (DGA) which is considered a healthy diet pattern for prediabetes. Diet adherence will be assessed with 3-day food diary in weeks 1-12. Study personnel and/or the study RDN will follow up with the participants during the study to review the food diaries.

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials

714

Recruited

6,143,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Published Research Related to This Trial

Over half of the participants in a dietary survey in France reported never consuming whole grains, with those who did consuming very low amounts (9.1 g/d in children and 14.4 g/d in adults).

Whole grain consumers had higher intakes of fiber, vitamins, and minerals, and in adults, increased whole grain consumption was linked to a significant decrease in the odds of being overweight or obese.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of whole grains in French children, adolescents and adults. Bellisle, F., Hébel, P., Colin, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11515761/

The development and testing of a single-arm feasibility and ... The purpose of this study was to assess the feasibility and acceptability of a whole foods diet for adults with prediabetes and their offspring prior to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05483972?term=AREA%5BBasicSearch%5D(Prediabetes)&rank=7

A Family-Centered Whole Foods Diet in Adults With ... This study will address the following aims: Aim 1: Design a family-centered whole foods diet adapted from the 2020-2025 DGA framework for 8-12 families that ...

3. trialstoday.org trialstoday.org/trial/NCT06482944

Whole Food for Families: A Pilot RCT of a Dietary Guidelines ... Aim 2: Conduct a pilot RCT to evaluate the preliminary effectiveness of a non-calorie restricted whole foods diet on adult HbA1c at 12 weeks and adult/child ...

4. withpower.com withpower.com/trial/phase-metabolic-diseases-8-2024-93e34

Whole Foods Diet for Prediabetes · Info for Participants What data supports the effectiveness of the Whole Foods for Families treatment for prediabetes? Research shows that eating whole grains, which are part of a ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12050600/

74 Feasibility and efficacy of a 12-week whole foods diet ... Primary outcomes include feasibility (≥80% retention and completion of study outcome measures) and acceptability (≥75% adult self-reported diet satisfaction).

6. cdn.nutrition.org cdn.nutrition.org/article/S2475-2991(24)00677-2/fulltext

Whole Foods for Prediabetes: Feasibility and Acceptability of a ... Findings from this study suggest that a whole foods diet is a feasible and acceptable intervention for high-risk for T2D families.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06482944

Whole Food for Families: A Pilot RCT of a Dietary ... have prediabetes (based on American Diabetes Association criteria of either fasting plasma glucose of ≥100 mg/dL, HgbA1c 5.7-6.4%, or 2-hour plasma glucose ...

8. diabetesjournals.org diabetesjournals.org/spectrum/article/25/4/238/32473/A-Low-Carbohydrate-Whole-Foods-Approach-to

A Low-Carbohydrate, Whole-Foods Approach to Managing ... Advise patients to aim for 30–35 g of total carbohydrates per meal in the form of several cups of vegetables and a piece of fruit. It may be ...

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/72/NCT05483972/ICF_000.pdf

NCT05483972 Study Title: Whole Food for Prediabetes This study will help us learn if adults with prediabetes and their children are interested in participating in and adopting a family-focused healthy diet.