Pilot Study on Mixed Nuts and Food Intake

Healthy Volunteers Clinical Trial

Official title:

Pilot Study on Mixed Nuts and Food Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247881
• Other study ID #: HS57
• Status: Completed
• Phase: N/A
• First received: August 9, 2017
• Last updated: November 9, 2017
• Start date: September 18, 2017
• Est. completion date: November 6, 2017

Study information

• Verified date: November 2017
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 6, 2017
• Est. primary completion date: November 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	USDA-ARS Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Mood questionnaire will be administered	A mood questionnaire will be administered.	Day 0, Day 8, and Day 29.