Clinical Trials Directory

Trials / Terminated

TerminatedNCT03947281

Snacks and Satiety

Almond Snacks and Satiety: a Randomized Intervention Trial Examining Acute and Chronic Effects

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
USDA, Western Human Nutrition Research Center · Federal
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

This study is designed to compare two types of snacks (almonds or a cereal-based snack), eaten between meals, on measures of appetite, including appetitive hormones, self-reported feelings of hunger and fullness, and food intake at a buffet meal or in the home environment. The investigators hypothesize that the acute responses of appetitive hormones to a meal challenge protocol will differ between almond and cereal-based snacks based on multivariate models of satiety that will be predictive of ad libitum food intake at a dinner meal as part of the meal challenge protocol. Further, the investigators will estimate if, under free-living conditions, self-selected and self-reported food intake will show appropriate energy compensation for the added calories of the snacks, and determine if one type of snack is superior to the other in this regard.

Detailed description

This study will use a randomized, parallel design that includes an almond snack intervention and a cereal-based snack intervention group. The almond intervention will be roasted, unsalted almonds at a level of 56 grams per day for 4 weeks. The cereal-based intervention will be isocaloric snacks provided in the form of a mixture of dry cereal, pretzels, and bread sticks for 4 weeks. A satiety test protocol will be done at the beginning and the end of the intervention period. Each test day will include measures of satiety responses to two standard meals, two snacks (either almonds or cereal-based snacks), and a dinner buffet. The protocol to evaluate satiety signals include tonic measures that may signal homeostasis to the brain and evaluation of episodic signals that may drive food intake In addition, other modulators of satiety will be tested including evaluation of preferences for palatable foods, self-reports of cravings and satiety using questionnaires, and perceived hunger, fullness, desire to eat.

Conditions

Interventions

TypeNameDescription
OTHERAlmond snackThe almond intervention will be roasted, unsalted almonds provided at 56 g/day for 28 days. Almonds provide approximately 350 kcals/day.
OTHERCereal-based snackThe cereal-based intervention will be a prepared mix of cereal, pretzels, and bread sticks prepared at the WHNRC. It will be provided at the level of 350 kcals per day for 28 days.

Timeline

Start date
2019-06-24
Primary completion
2022-08-08
Completion
2022-08-08
First posted
2019-05-13
Last updated
2024-10-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03947281. Inclusion in this directory is not an endorsement.