Snacking, Satiety &Weight: A Randomized, Controlled Trial

NCT ID: NCT02050165

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-12-31

Brief Summary

Proposed is a parallel-design randomized controlled trial to compare the effects of consuming two types of snacks on a daily basis for a 12-week period on health outcomes, diet quality, and self-reported satiety in a group of overweight adults. The types of snacks to be studied are KIND snack bars with almonds and typical American snack foods).

Detailed Description

Snacking has been implicated in the obesity epidemic, but judicious snacking can help control appetite and calorie intake and add nutrient-dense foods to the diet. The investigators hypothesize that snacking on nutrient-dense, highly satiating snack foods (i.e. KIND snacks with almonds) as compared to snacking on nutrient-dilute, energy-dense foods (i.e., conventional snack foods) will contribute to satiety, weight loss, and health improvements. The investigators further hypothesize that the benefits of healthful snacking are enhanced when portion is clearly defined and controlled by packaging. Finally, the investigators hypothesize that these effects will be seen even when study participants are given clear guidance about the calorie content of snack items, and how to make room for those calories in their diets.

Hypotheses:

1. Snacking on nutrient-dense, highly satiating snack foods (i.e. KIND snacks with almonds) as compared to snacking on nutrient-dilute, energy-dense foods (i.e., conventional snack foods) will contribute to satiety, weight loss, and health improvements.

2. The benefits of healthful snacking are enhanced when portion size is clearly defined and controlled by packaging.

3. These effects will be seen even when study participants are given clear guidance about the calorie content of snack items, and how to make room for those calories in their diets.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

KIND Bar

Daily inclusion of KIND Bars with almonds as a primary ingredient as part of the participant's usual diet, with diet counseling to adjust for the calories from the KIND Bars. KIND Bars that we will use in the study will include: Dark Chocolate Chili Almond; Cranberry Almond; Almond Walnut Macadamia; Pomegranate Blueberry Pistachio; Nut Delight; Fruit and Nut Delight; Almond and Apricot; Blueberry Pecan and Fiber.

Group Type: EXPERIMENTAL

KIND Bars

Intervention Type: DIETARY_SUPPLEMENT

Consumption of KIND Bars for 12 weeks

Typical American Snack

Daily inclusion of conventional snacks (as part of the participant's usual diet, with diet counseling to adjust for the calories from the snacks. The snacks will consist of cookies considered to be conventional snack foods that are nutrient-dilute (i.e. relatively low in nutrients) and energy-dense (i.e., relatively high in kcal). Examples of conventional snack foods will include: Nabisco Snackwell Creme Sandwich 1.7 oz pack, Nabisco Newtons Fig 2 oz pack, Nabisco Cips Ahoy! Chocolate Chip 1.4 oz pack, and Nabisco Oreo Double Stuff Chocolate 1.3 oz pack.

Group Type: EXPERIMENTAL

Typical American Snack

Intervention Type: DIETARY_SUPPLEMENT

Consumption of typical American snacks for 12 weeks

Interventions

KIND Bars

Consumption of KIND Bars for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Typical American Snack

Consumption of typical American snacks for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Man or woman age 25-75 years;
• Non-smoker;
• Sedentary;
• Overweight (BMI ≥25kg/m²) with waist circumference >40 inches (102 cm) for men and >35 inches (88 cm) for women;
• Interested in losing weight, but not actively involved with a diet or weight loss program.
• Snack regularly with pre-packaged snacks typically available in grocery stores or vending machines.
• Willing to consume snacks on a daily basis.

• Anticipated inability to complete study protocol for any reason;
• Current eating disorder;
• Diabetes;
• Sleep apnea;
• Actively involved with a diet or weight loss program;
• Other restricted diets due to allergy/intolerance (i.e. nut, gluten) or by choice (i.e., vegetarian, vegan);
• Regular exercise as defined by participating in moderate-intensity for at least 150 minutes/week.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kind LLC

UNKNOWN

Sponsor Role: collaborator

Griffin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David L. Katz, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Yale-Griffin Prevention Research Center

Valentine Y. Njike, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Yale-Griffin Preventin Research Center

Locations

Yale-Griffin Prevention Research Center

Derby, Connecticut, United States

Countries

United States

Other Identifiers

2013-01

Identifier Type: -

Identifier Source: org_study_id