Health Effects of Grain Foods in Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorPurdue University

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • High Whole Grain, Low Sugar

    Other intervention

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

  • Low Whole Grain, Low Sugar

    Other intervention

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

  • High Whole Grain, High Sugar

    Other intervention

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

  • Low Whole Grain, High Sugar

    Other intervention

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

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: High Whole Grain, Low SugarActive comparator 1 intervention
Group B: Low Whole Grain, Low SugarActive comparator 1 intervention
Group C: High Whole Grain, High SugarActive comparator 1 intervention
Group D: Low Whole Grain, High SugarActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Glycemia

blood sugar

Time frame
12 weeks

Secondary outcomes

1

Appetite

ingestive sensations measured by VAS ratings scale 1 (lowest) - 100 (highest)

Time frame
12 weeks
2

Taste Hedonics

palatability

Time frame
12 weeks
3

Energy Intake

kcals

Time frame
12 weeks
4

Body Weight

pounds

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Purdue University

Lead sponsor

Grain Foods Foundation

Collaborator