Davis, California 95616

  • Obesity

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Pre-menopausal - Body Mass Index 25 - 39.9 kg/m2 Exclusion Criteria: - Women who are post-menopausal or peri-menopausal - BMI < 25 or > 40 kg/m2 - Allergies to tree nuts - Using any hormonal contraception including oral contraceptive, contraceptive patch, contraceptive ring, contraceptive injection (e.g. Depo-Provera), or contraceptive implant (e.g. Nexplanon/Implanon) - Menstrual cycle lengths < 25 days or > 45 days, or have amenorrhea, eumenorrhea, or polymenorrhea. - Pregnant or nursing within the last 6 months, or plan to become pregnant during the trial - Medical diagnoses of chronic diseases including cardiovascular or pulmonary diseases, renal disease, cancer, type 1 or type 2 diabetes mellitus, thyroid disease requiring medication, inflammatory bowel disease, irritable bowel disease, or those with recent major surgeries - current medical diagnosis of polycystic ovarian syndrome (PCOS).


NCT ID:

NCT03947281


Primary Contact:

Ellen L Bonnel, PhD
Phone: 530-752-4184
Email: ellen.bonnel@ars.usda.gov


Backup Contact:

Email: nancy.keim@ars.usda.gov
Nancy L Keim, PhD
Phone: 530-752-4163


Location Contact:

Davis, California 95616
United States

Ellen L Bonnel, PhD
Phone: 530-752-4184
Email: ellen.bonnel@ars.usda.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 26, 2021

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