Grain Foods for Diet Quality

Overseen By Richard Mattes, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Purdue University

Must not be taking: Blood thinners

Disqualifiers: Grain allergies, Celiac, Smoker, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 14 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of grain foods affect health and diet quality. Participants will consume either whole grain foods (such as whole grain cereals and breads) or refined grain foods with varying sugar levels to assess impacts on appetite, weight, and blood pressure. It suits individuals who currently consume little whole grain and a high amount of added sugar. Eligible participants must be between 21 and 60 years old and have a blood sugar level indicating prediabetes. Those with food allergies, smokers, or individuals planning significant weight changes during the study are not eligible. As an unphased trial, this study provides a unique opportunity to contribute to understanding the impact of grain foods on health and diet quality.

Will I have to stop taking my current medications?

The trial prefers participants not to use medications, but if you are on medication, you must have been on a stable dose for 3 months and plan to stay on the same dose during the trial.

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

Research shows that whole grain foods are generally safe and beneficial for health. Studies have found that people who consume more whole grains tend to have healthier diets, with increased fiber, protein, and important minerals like iron and calcium.

Whole grain foods can help manage cholesterol levels, body weight, and blood pressure while providing essential vitamins and minerals. These findings suggest that whole grains are well-tolerated, with no major side effects reported.

In this trial, different groups will consume varying amounts of whole grains and sugar. Overall, whole grains should be safe to include in the diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different amounts of whole grain and sugar in our diets can impact overall diet quality. Unlike standard dietary recommendations that often focus solely on reducing sugar or increasing fiber, this trial directly compares combinations of whole grain intake with varying sugar levels. By doing so, it aims to uncover the potential benefits of whole grains beyond just fiber content, possibly offering new insights into optimizing diet quality. This could lead to more tailored dietary guidelines that balance whole grain and sugar intake for better health outcomes.

What evidence suggests that this trial's treatments could be effective for diet quality?

Research has shown that eating whole grains can lower the risk of type 2 diabetes, heart disease, and obesity. Whole grains contain important nutrients like fiber, iron, and B vitamins, which refined grains lack. Studies have found that these nutrients can improve diet quality and help maintain a healthy weight. People who consume more whole grains typically have better heart health and weigh less than those who eat refined grains. This trial will compare different dietary patterns, including low and high whole grain intake with varying sugar levels, to assess their impact on diet quality. Therefore, adding whole grains to a diet can be a smart choice for better health. ^{1 5 6 7 8}

Who Is on the Research Team?

Richard Mattes, PhD

Principal Investigator

Purdue University

Are You a Good Fit for This Trial?

This trial is for adults interested in understanding how different types of grain foods affect their health. Participants should typically consume a diet that may be considered poor, healthy, or unhealthy. Specific details on eligibility criteria are not provided.

Inclusion Criteria

Hemoglobin A1c concentration between 5.7 and 6.4%

Low customary intake of whole grain foods (less than 2 servings per day) and high energy from added sugar (greater than 10% energy)

I am between 21 and 60 years old.

Exclusion Criteria

Intended weight loss or gain during the study period

Grain or dairy sensitivities or allergies or celiac disease

Smoker

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline

Baseline measurements are taken before the intervention begins

1 week

1 visit (in-person)

Treatment

Participants follow prescribed diets with varying grain and sugar content

14 weeks

Visits at weeks 2, 5, 8, 11, 14 (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Whole Grain Foods

Trial Overview

The study is testing the effects of whole versus refined grains with varying sugar levels on health factors like taste preferences, hunger, food intake, weight, blood pressure and blood sugar/fat levels. It's exploring if grain products can improve these aspects when controlling for sugars and fats.

How Is the Trial Designed?

Group I: Low Whole Grain, High Sugar Active Control 1 Intervention

3 servings of whole grain and \>13% energy from added sugars.

Group II: Low Whole Grain, Low Sugar Active Control 1 Intervention

3 servings of whole grain and \<13% energy from added sugars.

Group III: High Whole Grain, High Sugar Active Control 1 Intervention

6 servings of whole grain and \>13% energy from added sugars.

Group IV: High Whole Grain, Low Sugar Active Control 1 Intervention

6 servings of whole grain and \<13% energy from added sugars.

Who Is Running the Clinical Trial?

Purdue University

Lead Sponsor

Trials

239

Recruited

72,200+

Grain Food Foundation

Collaborator

Trials

1

Recruited

120+

Grain Foods Foundation

Collaborator

Trials

2

Recruited

160+

Published Research Related to This Trial

Grains are essential in many diets worldwide, providing key macronutrients like carbohydrates, proteins, and fats, as well as important micronutrients and dietary fiber, especially in wholegrain forms.

The food industry aims to create safe and appealing grain-based products, including both gluten-containing and gluten-free options, while enhancing their nutritional value to meet consumer demands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Value of Grain-Based Foods. Carcea, M.[2020]

Breads and breakfast cereals that meet the ≤10:1 carbohydrate:fibre ratio generally have good nutritional quality, with breads showing medium fat and low sugar content, while breakfast cereals tend to have higher sugar levels.

The study found that as the carbohydrate:fibre ratio decreased in breads, fat content increased, and in breakfast cereals, a higher carbohydrate:fibre ratio was associated with increased sugar content, indicating a need for careful selection even within the wholegrain category.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the ≤10:1 wholegrain criterion in identifying nutrient quality and health implications of UK breads and breakfast cereals. Ghodsian, B., Madden, AM.[2023]

The Healthgrain Forum recommends that foods can be labeled as 'whole grain' if they contain at least 30% whole-grain ingredients and more whole grain than refined grain, promoting clearer labeling for consumers.

This new definition aims to standardize whole-grain labeling across various food products, encouraging better consumer choices and potentially increasing whole grain consumption to help prevent chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: A Definition for Whole-Grain Food Products-Recommendations from the Healthgrain Forum. Ross, AB., van der Kamp, JW., King, R., et al.[2023]

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]

Whole grains (WG) are associated with numerous health benefits, including reduced risks of obesity, cardiovascular disease, and certain cancers, as well as lower mortality rates, highlighting their importance in dietary guidelines worldwide.

To increase WG consumption, both consumers need better education on the benefits and identification of WG foods, and the food industry must create appealing, clearly-labeled products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole grains: benefits and challenges. Jones, JM., Engleson, J.[2017]

There is currently no internationally accepted definition of whole grain, which complicates the investigation of health claims related to whole grain products.

A cautious approach is recommended, starting with a restricted list of grains based on scientific evidence, to ensure that health claims are valid, sustainable, and based on a clear understanding of the health benefits associated with specific grain components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole grain for whom and why? Frølich, W., Aman, P.[2021]

Increased consumption of whole-grain foods is linked to a lower risk of cardiovascular disease, type 2 diabetes, and certain cancers, as well as better digestive health and lower body mass index (BMI).

The evidence supporting the health benefits of whole grains primarily comes from observational studies, but intervention studies are increasingly showing similar positive effects, highlighting the need for standardized definitions of 'whole grain' to guide dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-grain foods and chronic disease: evidence from epidemiological and intervention studies. Seal, CJ., Brownlee, IA.[2022]

The 2000 Dietary Guidelines for Americans introduced a specific guideline for grain foods, highlighting the health benefits of whole grains, which are still under-consumed despite overall grain intake increasing since the 1970s.

Barriers to whole grain consumption include low consumer awareness of their health benefits, difficulty in identifying whole-grain products, higher prices, and perceptions of inferior taste, prompting the FDA to authorize a health claim to improve visibility and availability of whole-grain foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choose a variety of grains daily, especially whole grains: a challenge for consumers. Kantor, LS., Variyam, JN., Allshouse, JE., et al.[2022]

Regularly eating whole grain foods (2-3 servings per day) is linked to lower risks of cardiovascular disease, diabetes, and certain cancers, as well as a decrease in overall premature death.

Despite these benefits, many people in Western countries consume less than one serving of whole grains per day, highlighting the need for strategies to encourage higher intake for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who consumes whole grains, and how much? Lang, R., Jebb, SA.[2019]

Whole grains are rich in essential nutrients like dietary fiber, B vitamins, and minerals, which are often lacking in the American diet, and they may help prevent diseases through various mechanisms such as antioxidant protection and gastrointestinal benefits.

Despite the known benefits, average consumption of whole grains is significantly below the recommended intake of 3 servings per day, with many people consuming 1 or fewer servings, highlighting the need for increased awareness and dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of whole grains in disease prevention. Slavin, JL., Jacobs, D., Marquart, L., et al.[2022]

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