Clinical trial NCT03947281: Snacks and Satiety
Official title: Almond Snacks and Satiety: a Randomized Intervention Trial Examining Acute and Chronic Effects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Eating Behavior
Overweight
Obesity
Keywords: satiety
gastrointestinal hormones
appetite
Dietary fiber
food cravings
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: Almond Board of California
First posted: 2019-05-13
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a randomized, parallel design that includes an almond snack group and a cereal-based snack group. The intervention will be for 28 days. The almond intervention will be roasted almonds 56 grams/day. The cereal-based snack intervention will be the caloric equivalent.
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility 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).

Primary outcomes:
measure: Baseline level and change in cholecystokinin
timeFrame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
measure: Baseline level and change in peptide-YY
timeFrame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
measure: Baseline level and change in glucose-like peptide 1
timeFrame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
measure: Baseline level and change in gastric inhibitory peptide
timeFrame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
measure: Baseline level and change in insulin
timeFrame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
measure: Baseline level and change in glucose
timeFrame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
measure: Baseline level and change in oleoylethanolamide
timeFrame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
measure: Baseline level and change in ghrelin
timeFrame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
measure: Baseline level and change in leptin
timeFrame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
measure: Baseline level and change in orexin
timeFrame: Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
measure: Baseline level and change in endocannabinoid profiles
timeFrame: Baseline, 60 minutes before lunch meal, and 10, 30, and 150 minutes after a lunch meal
measure: Baseline level and change in hunger
timeFrame: Baseline, every 30 minutes up to 480 minutes, and immediately before and after three meals
measure: Baseline level and change in satiety
timeFrame: Baseline, every 30 minutes up to 480 minutes, and immediately before and after three meals
measure: Change in food intake at a dinner meal
timeFrame: Week 1 and 4
Secondary outcomes:
measure: Body composition reference measurement
timeFrame: Week 1
measure: Change in body weight
timeFrame: Weeks 0, 1, 2, 3, and 4
measure: Change in body fat
timeFrame: Weeks 0, 1, 2, 3, and 4
measure: Change in lean body mass
timeFrame: Weeks 0, 1, 2, 3, and 4
measure: Change in total body water
timeFrame: Weeks 0, 1, 2, 3, and 4
measure: Change in waist circumference
timeFrame: Week 0 and 4
measure: Change in hip circumference
timeFrame: Week 0 and 4
measure: Change in Food Choice
timeFrame: Baseline and following a lunch meal at Weeks 0 and 4
measure: Change in food craving
timeFrame: Week 0 and 4
measure: Change in self-reported satiety
timeFrame: Week 0 and 4
measure: Power of food questionnaire
timeFrame: Week 0
measure: Food addiction questionnaire
timeFrame: Week 0
measure: Eating behavior
timeFrame: Week 0
measure: Three factor eating inventory
timeFrame: Week 0
measure: Premenstrual Syndrome
timeFrame: Week 0
measure: General health and well-being
timeFrame: Week 0
measure: Usual physical activity
timeFrame: Week 0
measure: Change in metabolic rate
timeFrame: Baseline and 1 hour before lunch meal, 1 hour after lunch meal, and 1 hour after mid-afternoon snack
measure: Change in dietary intake
timeFrame: Ten dietary recalls collected at home during weeks 1-4
measure: Genetic risk of obesity
timeFrame: Week 1
measure: Change in liver fat
timeFrame: Week 0 and 4
measure: Change in liver stiffness
timeFrame: Week 0 and 4
Other outcomes:
Locations:
city: Davis
country: United States
facility: USDA, ARS, Western Human Nutrition Research Center
state: California
Study officials:
References: