Pilot Study on Mixed Nuts and Food Intake

The objectives of this study are 1) to determine if consumption of mixed nuts influences food intake and choice, and 2) to determine how personality traits affect food choice, including mood, stress, tendency to seek approval, tendency toward food cravings, and approach to food intake control.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Nut Free Diet; Other: Added Mixed Nuts Diet

Detailed Description

The condition of being overweight or obese has skyrocketed in recent decades, bringing with it many secondary health problems. Therefore, it is important to seek strategies to promote weight loss and to assist in weight maintenance after weight loss. Different diet compositions may have different effects on satiety and thus affect food choice. A pilot study will be conducted to determine if mixed nuts affect food selection and intake. Questionnaires will also be administered to determine if personality characteristics are also influencing food choice.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • USDA-ARS Beltsville Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 21 to 60 Years Old
• 5 year cancer-free

Exclusion Criteria:

• pregnant, lactating, or intending to become pregnant during the study
• known allergy to study foods, including nuts
• use of tobacco products
• history of bariatric surgery or nutrient malabsorption disease or diseases requiring special diet
• Crohn's disease or diverticulitis
• suspected or known strictures, fistulas, or physiological/mechanical GI obstruction
• Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
• Self report of alcohol or substance abuse within the past 12 months and/or current acute treatment or participation in a rehabilitation program for those problems (long-term participation in Alcoholics Anonymous is not an exclusion)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Nut Free Diet; Participants will consume whatever they like, as much as they like, from a pre-determined buffet with 0 g/d of mixed nuts.	Other: Nut Free Diet; Participants will consume whatever they like, as much as they like, from a pre-determined buffet with 0 g/d of mixed nuts.; Other Names: Control Diet
ACTIVE_COMPARATOR: Added Mixed Nuts Diet; Participants will consume whatever they like, as much as they like, from a pre-determined buffet which will include 2 servings (2 ounces) of mixed nuts per day (1 serving just prior to breakfast and 1 serving as an afternoon snack).	Other: Added Mixed Nuts Diet; Participants will consume whatever they like, as much as they like, from a pre-determined buffet which will include 2 servings (2 ounces) of mixed nuts per day (1 serving just prior to breakfast and 1 serving as an afternoon snack).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass will be measured	To track the change in body mass, subjects will be weighed on a scale.	Day 0, prior to beginning the diet, day 8, day 29, and day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaires will be administered	Questionnaires addressing control of eating, eating attitude, social approval, and social desirability will be administered.	Once during the study, no specific time.
Mood questionnaire will be administered	A mood questionnaire will be administered.	Day 0, Day 8, and Day 29.

Collaborators and Investigators

• Sponsor: USDA Beltsville Human Nutrition Research Center
• Investigators: Principal Investigator: Janet Novotny, USDA-ARS, Beltsville Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2017
• Primary Completion (ACTUAL): November 6, 2017
• Study Completion (ACTUAL): November 6, 2017

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (ACTUAL): August 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HS57

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No