## Protocol Section
### Identification Module
**NCT ID:** NCT06339879

**Brief Title:** Health Effects of Grain Foods in Adults

**Official Title:** Health Effects of Grain Foods in Adults

#### Organization Study ID Info
**ID:** IRB-2023-1071
#### Organization
**Class:** OTHER
**Full Name:** Purdue University
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-04

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-02

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-18

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Study First Submit Date:** 2023-12-11
**Study First Submit QC Date:** 2024-03-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Grain Food Foundation

#### Lead Sponsor

**Class:** OTHER

**Name:** Purdue University

#### Responsible Party

**Investigator Affiliation:** Purdue University

**Investigator Full Name:** Richard Mattes

**Investigator Title:** Distinguished Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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 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

### Conditions Module

**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

- lipemia

- hedonics

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Parallel assignment

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: High Whole Grain, Low Sugar

**Label:** High Whole Grain, Low Sugar

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Other: Low Whole Grain, Low Sugar

**Label:** Low Whole Grain, Low Sugar

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

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

**Intervention Names:**

- Other: High Whole Grain, High Sugar

**Label:** High Whole Grain, High Sugar

**Type:** ACTIVE_COMPARATOR

#### Arm Group 4

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

**Intervention Names:**

- Other: Low Whole Grain, High Sugar

**Label:** Low Whole Grain, High Sugar

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- High Whole Grain, Low Sugar

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

**Name:** High Whole Grain, Low Sugar

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Low Whole Grain, Low Sugar

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

**Name:** Low Whole Grain, Low Sugar

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- High Whole Grain, High Sugar

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

**Name:** High Whole Grain, High Sugar

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Low Whole Grain, High Sugar

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

**Name:** Low Whole Grain, High Sugar

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** blood sugar

**Measure:** Glycemia

**Time Frame:** 12 weeks

#### Secondary Outcomes

**Description:** ingestive sensations measured by VAS ratings

**Measure:** Appetite

**Time Frame:** 12 weeks

**Description:** palatability

**Measure:** Taste Hedonics

**Time Frame:** 12 weeks

**Description:** kcals

**Measure:** Energy Intake

**Time Frame:** 12 weeks

**Description:** pounds

**Measure:** Body Weight

**Time Frame:** 12 weeks

**Description:** mm mercury

**Measure:** Systolic and Diastolic Blood Pressure

**Time Frame:** 12 weeks

**Description:** Blood lipids

**Measure:** Lipemia

**Time Frame:** 12 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** georgej@purdue.edu

**Name:** Judy George, BS

**Phone:** 4654946192

**Role:** CONTACT

**Contact 2:**

**Email:** mattes@purdue.edu

**Name:** Richard Mattes, PhD

**Phone:** 7654940662

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** West Lafayette

**Contacts:**

***Contact 1:***

- **Email:** mattes@purdue.edu

- **Name:** Richard D Mattes, PhD

- **Phone:** 765-494-0662

- **Role:** CONTACT

***Contact 2:***

- **Name:** Richard D Mattes, PhD, RD, MPH

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Purdue University

**State:** Indiana

**Status:** RECRUITING

**Zip:** 17907

#### Overall Officials

**Official 1:**

**Affiliation:** Purdue University

**Name:** Richard Mattes, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** deidentified data will be shared.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M10000

- Name: Hyperlipidemias

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
