Clinical trial NCT02050165: Snacking, Satiety &Weight: A Randomized, Controlled Trial
Official title: Snacking, Satiety &Weight: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
snacks
satiety
hunger
Lead sponsor: Griffin Hospital
Sponsor class: OTHER
Collaborators: name: Kind LLC
First posted: 2014-01-30
Enrollment: 34
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Exclusion Criteria:

* Failure to meet inclusion criteria;
* 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.

Primary outcomes:
measure: Body Mass Index
timeFrame: 12 weeks
Secondary outcomes:
measure: Body Composition
timeFrame: 12 Week
measure: Waist circumference
timeFrame: 12 Week
measure: Blood Pressure
timeFrame: 12 Week
measure: Lipid Profile
timeFrame: 12 Week
measure: Diet quality/key nutrients
timeFrame: 12 week
measure: Hunger/Satiety
timeFrame: 12 Week
measure: Quality of Life
timeFrame: 12 Week
measure: Physical Activity
timeFrame: 12 week
Other outcomes:
Locations:
city: Derby
country: United States
facility: Yale-Griffin Prevention Research Center
state: Connecticut
Study officials:
affiliation: Yale-Griffin Prevention Research Center
name: David L. Katz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale-Griffin Preventin Research Center
name: Valentine Y. Njike, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: