High Whole Grain and Low SugarNCT06339879
Health Effects of Grain Foods in Adults
A study testing High Whole Grain, Low Sugar, Low Whole Grain, Low Sugar and High Whole Grain, High Sugar in people with High Whole Grain and Low Sugar and Medium Whole Grain and Low Sugar, run by Purdue University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- High Whole Grain and Low Sugar, Medium Whole Grain and Low Sugar, Low Whole Grain and Low Sugar
- What is being tested?
- High Whole Grain, Low Sugar, Low Whole Grain, Low Sugar and High Whole Grain, High Sugar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male and female; 21 to 60 years old; Hemoglobin A1c concentration between 5.7 and 6.4%
- Prefer no use of medications, but if on medication, must have been on a stable dose for 3 months and plan to remain at the same dose for the duration of the trial.
- low customary intake of whole grain foods (less than 2 servings per day) and high energy from added sugar (greater than 10% energy).
Who cannot join
- Grain or dairy sensitivities or allergies or celiac disease; sensitivity or allergy to other foods that would result in refusal to eat a class of foods.
- smoker
- intended weight loss or gain during the study period; intended change of activity level during the study period
- use of blood thinners
- prior gastrointestinal surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Purdue University
West Lafayette, Indiana, 17907
Richard D Mattes, PhD, 765-494-0662, mattes@purdue.edu
Richard D Mattes, PhD, RD, MPH
About this study
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.
Read the detailed description
This 16-week, randomized, controlled, parallel-arm, clinical trial will assess the effects of consuming four different categories of grain foods on taste hedonics, appetite, food/energy intake, body weight, and blood pressure as well as acute and longer-term glycemia and lipemia. It will also examine the effects of foods varying in grain/carbohydrate composition on the microbiome and microbiota functionality. One hundred and twenty adults will be recruited and randomly assigned to one of four intervention groups. These groups will be defined by the diets they are prescribed. All will be prescribed diets containing approximately 50%; 35% and 15% energy from carbohydrate, fat and protein, respectively. Grain foods will comprise 50% of the carbohydrate component (i.e., 25% of total energy). The grain foods will be assigned to one of four categories based on whole grain content and concentrations of added sugars. The grain foods meeting these criteria will have the following composition:
Group 1 - High Whole Grain, Low Sugar 6 servings of whole grain and <13% energy from added sugars.
Group 2 - Low Whole Grain, Low Sugar 3 servings of whole grain and <13% energy from added sugars.
Group 3 - High Whole Grain, High Sugar 6 servings of whole grain and >13% energy from added sugars.
Group 4 - Low Whole Grain, High Sugar 3 servings of whole grain and >13% energy from added sugars.
Detailed Study Design
The study measures and timing are outlined in the following table:
Screening Week 1 Baseline Week 2 Week 5 Week 8 Week 11 Week 14 Fasting Blood X X X XX MTT X X X Weight X X X X X X Body Composition X X CGM X X X Intake X Hedonics (palatability) X X X Appetite X X X Activity X X X Blood Pressure X X X X X X Microbiota X X X X X Compliance X X X X X MTT = Meal Tolerance Test; DXA= Dual-energy X-ray Absorptiometry; CGM=Continuous glucose monitoring
- Conditions
- High Whole Grain and Low Sugar, Medium Whole Grain and Low Sugar, Low Whole Grain and Low Sugar, Low Whole Grain and High Sugar
- Being tested
- High Whole Grain, Low Sugar, Low Whole Grain, Low Sugar, High Whole Grain, High Sugar, Low Whole Grain, High Sugar
- Keywords
- whole grain, refined grain, glycemia, appetite, food intake, microbiome, body weight, blood pressure, lipemia, hedonics
- Medical subject headings
- Body Weight, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Whole Grain, Low SugarOther
6 servings of whole grain and <13% energy from added sugars.
Low Whole Grain, Low SugarOther
3 servings of whole grain and <13% energy from added sugars.
High Whole Grain, High SugarOther
6 servings of whole grain and >13% energy from added sugars.
Low Whole Grain, High SugarOther
3 servings of whole grain and >13% energy from added sugars.
| Study group | Role | What they receive |
|---|---|---|
| High Whole Grain, Low Sugar | Active comparator | 6 servings of whole grain and <13% energy from added sugars. Receives: Other: High Whole Grain, Low Sugar |
| Low Whole Grain, Low Sugar | Active comparator | 3 servings of whole grain and <13% energy from added sugars. Receives: Other: Low Whole Grain, Low Sugar |
| High Whole Grain, High Sugar | Active comparator | 6 servings of whole grain and >13% energy from added sugars. Receives: Other: High Whole Grain, High Sugar |
| Low Whole Grain, High Sugar | Active comparator | 3 servings of whole grain and >13% energy from added sugars. Receives: Other: Low Whole Grain, High Sugar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemia
blood sugar
Measured: 12 weeks
Secondary outcomes (6)
Appetite
ingestive sensations measured by VAS ratings scale 1 (lowest) - 100 (highest)
Measured: 12 weeks
Taste Hedonics
palatability
Measured: 12 weeks
Energy Intake
kcals
Measured: 12 weeks
Body Weight
pounds
Measured: 12 weeks
Systolic and Diastolic Blood Pressure
mm mercury
Measured: 12 weeks
Lipemia
Blood lipids
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start18 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Whole Grain and Low SugarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Grain Foods Foundation
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
- Investigators
- Richard Mattes, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339879
- Sponsor's protocol ID
- IRB-2023-1071
- Status last verified
- Jul 2024
- First submitted
- 11 Dec 2023
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: deidentified data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Grain Foods in Adults
- ClinicalTrials.gov ID
- NCT06339879
- Acronym / sponsor ID
- IRB-2023-1071
- Conditions
- High Whole Grain and Low Sugar, Medium Whole Grain and Low Sugar, Low Whole Grain and Low Sugar, Low Whole Grain and High Sugar
- Keywords
- whole grain, refined grain, glycemia, appetite, food intake, microbiome, body weight, blood pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Grain Foods Foundation
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This 16-week, randomized, controlled, parallel-arm, clinical trial will assess the effects of consuming four different categories of grain foods on taste hedonics, appetite, food/energy intake, body weight, and blood pressure as well as acute and longer-term glycemia and lipemia. It will also examine the effects of foods varying in grain/carbohydrate composition on the microbiome and microbiota functionality. One hundred and twenty adults will be recruited and randomly assigned to one of four intervention groups. These groups will be defined by the diets they are prescribed. All will be prescribed diets containing approximately 50%; 35% and 15% energy from carbohydrate, fat and protein, respectively. Grain foods will comprise 50% of the carbohydrate component (i.e., 25% of total energy). The grain foods will be assigned to one of four categories based on whole grain content and concentrations of added sugars. The grain foods meeting these criteria will have the following composition:
Group 1 - High Whole Grain, Low Sugar 6 servings of whole grain and <13% energy from added sugars.
Group 2 - Low Whole Grain, Low Sugar 3 servings of whole grain and <13% energy from added sugars.
Group 3 - High Whole Grain, High Sugar 6 servings of whole grain and >13% energy from added sugars.
Group 4 - Low Whole Grain, High Sugar 3 servings of whole grain and >13% energy from added sugars.
Detailed Study Design
The study measures and timing are outlined in the following table:
Screening Week 1 Baseline Week 2 Week 5 Week 8 Week 11 Week 14 Fasting Blood X X X XX MTT X X X Weight X X X X X X Body Composition X X CGM X X X Intake X Hedonics (palatability) X X X Appetite X X X Activity X X X Blood Pressure X X X X X X Microbiota X X X X X Compliance X X X X X MTT = Meal Tolerance Test; DXA= Dual-energy X-ray Absorptiometry; CGM=Continuous glucose monitoring
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| High Whole Grain, Low Sugar | Active comparator | Other: High Whole Grain, Low Sugar6 servings of whole grain and <13% energy from added sugars. |
| Low Whole Grain, Low Sugar | Active comparator | Other: Low Whole Grain, Low Sugar3 servings of whole grain and <13% energy from added sugars. |
| High Whole Grain, High Sugar | Active comparator | Other: High Whole Grain, High Sugar6 servings of whole grain and >13% energy from added sugars. |
| Low Whole Grain, High Sugar | Active comparator | Other: Low Whole Grain, High Sugar3 servings of whole grain and >13% energy from added sugars. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male and female; 21 to 60 years old; Hemoglobin A1c concentration between 5.7 and 6.4%
- Prefer no use of medications, but if on medication, must have been on a stable dose for 3 months and plan to remain at the same dose for the duration of the trial.
- low customary intake of whole grain foods (less than 2 servings per day) and high energy from added sugar (greater than 10% energy).
Key exclusion criteria (5 listed)
- Grain or dairy sensitivities or allergies or celiac disease; sensitivity or allergy to other foods that would result in refusal to eat a class of foods.
- smoker
- intended weight loss or gain during the study period; intended change of activity level during the study period
- use of blood thinners
- prior gastrointestinal surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Whole Grain, Low Sugar6 servings of whole grain and <13% energy from added sugars. | Other | High Whole Grain, Low Sugar |
| Low Whole Grain, Low Sugar3 servings of whole grain and <13% energy from added sugars. | Other | Low Whole Grain, Low Sugar |
| High Whole Grain, High Sugar6 servings of whole grain and >13% energy from added sugars. | Other | High Whole Grain, High Sugar |
| Low Whole Grain, High Sugar3 servings of whole grain and >13% energy from added sugars. | Other | Low Whole Grain, High Sugar |
Primary outcome
Glycemia
Time frame: 12 weeks
blood sugar
6 secondary outcomes
Appetite
Time frame: 12 weeks
Taste Hedonics
Time frame: 12 weeks
Energy Intake
Time frame: 12 weeks
Body Weight
Time frame: 12 weeks
Systolic and Diastolic Blood Pressure
Time frame: 12 weeks
Lipemia
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No. deidentified data will be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Mattes, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Whole Grain, Low Sugar, Low Whole Grain, Low Sugar and High Whole Grain, High Sugar in people with High Whole Grain and Low Sugar and Medium Whole Grain and Low Sugar, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judy George, BS (4654946192, georgej@purdue.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemia (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.