Pilot Study on Mixed Nuts and Food Intake

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study on Mixed Nuts and Food Intake

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Nut Free Diet
* Other: Added Mixed Nuts Diet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nut Free Diet<br>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<br>* Participants will consume whatever they like, as much as they like, from a pre-determined buffet with 0 g/d of mixed nuts.<br>* Other names: Control Diet;|
| Active Comparator: Added Mixed Nuts Diet<br>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<br>* 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).<br>|

What is the study measuring?
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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. |