Pilot Study on Mixed Nuts and Food Intake

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: Added Mixed Nuts Diet; Other: Nut Free Diet

• Registration Number: NCT03247881
• Lead Sponsor: USDA Beltsville Human Nutrition Research Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-14
• Study Start: 2017-09-18
• Status Verified: 2017-11
• Primary Completion: 2017-11-06
• Study Completion: 2017-11-06
• Last Update Submitted: 2017-11-09
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Added Mixed Nuts Diet	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).
Nut Free Diet	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

USDA-ARS Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States