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

Trial Summary

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.

What data supports the effectiveness of the treatment Whole Grain Foods for improving diet quality?

Research shows that eating whole grain foods is linked to a lower risk of heart disease, diabetes, and some cancers, as well as better digestive health and weight management. Whole grains are rich in important nutrients like fiber, vitamins, and minerals, which contribute to these health benefits. ^{1 2 3 4 5}

Is it safe to consume whole grain foods?

Whole grain foods are generally considered safe for human consumption and are associated with various health benefits, such as reducing the risk of heart disease and diabetes. They are an important part of a healthy diet and provide essential nutrients. ^{1 4 6 7 8}

How does the treatment of whole grain foods differ from other treatments for improving diet quality?

Whole grain foods are unique because they retain key nutrients and phytochemicals that are often lost in refined grains, offering health benefits like reduced risk of chronic diseases and better digestive health. Unlike other treatments, whole grains are a natural food-based approach that can be easily incorporated into daily meals, promoting overall diet quality without the need for medication. ^{3 4 6 9 10}

What is the purpose of this trial?

This study will assess the effects of eating whole grain foods versus refined grain foods with different amounts of added sugar. It is hypothesized that a diet including grain products will have beneficial effects on taste hedonics, appetite, food/energy intake, body weight, blood pressure, acute and chronic glycemia and acute and chronic lipemia compared to customary diets controlling for added sugars, saturated fats and sodium.

Research Team

Richard Mattes, PhD

Principal Investigator

Purdue University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

References

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

Who consumes whole grains, and how much? [2019]

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

The role of whole grains in disease prevention. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Whole-grain foods and chronic disease: evidence from epidemiological and intervention studies. [2022]

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

Perspective: A Definition for Whole-Grain Food Products-Recommendations from the Healthgrain Forum. [2023]

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

Whole grains: benefits and challenges. [2017]

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

Choose a variety of grains daily, especially whole grains: a challenge for consumers. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Consumption of whole grains in French children, adolescents and adults. [2021]

8. Sweden pubmed.ncbi.nlm.nih.gov

Whole grain for whom and why? [2021]

9. England pubmed.ncbi.nlm.nih.gov

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

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

Nutritional Value of Grain-Based Foods. [2020]