Snacks and Satiety
- Conditions
- Eating BehaviorOverweightObesity
- Interventions
- Other: Almond snackOther: Cereal-based snack
- Registration Number
- NCT03947281
- Lead Sponsor
- USDA, Western Human Nutrition Research Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 10
- Pre-menopausal
- Body Mass Index 25 - 39.9 kg/m2
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Almond snack Almond snack The almond intervention will be roasted almonds 56 grams/day for 28 days. The caloric value is approximately 350 kcals. Cereal-based snack Cereal-based snack The cereal-based intervention will be a mixture of dry cereal, pretzels, and bread sticks prepared by the Western Human Nutrition Research Center (WHNRC). The caloric value is approximately 350 kcals.
- Primary Outcome Measures
Name Time Method Baseline level and change in oleoylethanolamide Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal Oleoylethanolamide measured by mass spectrometry in blood
Baseline level and change in hunger Baseline, every 30 minutes up to 480 minutes, and immediately before and after three meals Self-reported feelings of hunger measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Baseline level and change in cholecystokinin Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal Cholecystokinin (CCK) measured in blood using an antibody based assay
Baseline level and change in peptide-YY Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal Peptide-YY (PYY) measured in blood using an antibody based assay
Baseline level and change in glucose-like peptide 1 Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal Glucose-like peptide 1 (GLP-1) measured in blood using an antibody based assay
Baseline level and change in insulin Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal Insulin measured in blood using an antibody based assay
Baseline level and change in leptin Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal Leptin measured in blood using an antibody based assay
Baseline level and change in orexin Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal Orexin measured in blood using an antibody based assay
Baseline level and change in glucose Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal Glucose measured by standard chemistry in blood
Baseline level and change in gastric inhibitory peptide Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal Gastric inhibitory peptide (GIP) measured in blood using an antibody based assay
Baseline level and change in ghrelin Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal Ghrelin measured in blood using an antibody based assay
Baseline level and change in endocannabinoid profiles Baseline, 60 minutes before lunch meal, and 10, 30, and 150 minutes after a lunch meal Endocannabinoid profiles measured by mass spectrometry in blood
Baseline level and change in satiety Baseline, every 30 minutes up to 480 minutes, and immediately before and after three meals Self-reported feelings of fullness measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Change in food intake at a dinner meal Week 1 and 4 Calories consumed at a dinner meal following the satiety protocol
- Secondary Outcome Measures
Name Time Method Change in total body water Weeks 0, 1, 2, 3, and 4 measured in kg using multi frequency bioimpedance
Body composition reference measurement Week 1 Body composition (fat mass and fat-free mass in kg) will be measured once during the study using dual energy x-ray absorptiometry (DEXA)
Change in body weight Weeks 0, 1, 2, 3, and 4 measured in kg
Premenstrual Syndrome Week 0 Premenstrual Syndrome screening questionnaire measured once. Scale is a 4-point likert. Subscales for premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD), reported separately.
Change in waist circumference Week 0 and 4 measured in cm
Change in hip circumference Week 0 and 4 measured in cm
Change in Food Choice Baseline and following a lunch meal at Weeks 0 and 4 Food choice computer-based tests from Leeds, United Kingdom, will be used to estimate explicit liking and implicit wanting for several different categories of foods.
Food addiction questionnaire Week 0 Yale food addiction questionnaire measured once on a 5-point likert scale
Change in body fat Weeks 0, 1, 2, 3, and 4 measured in kg using multi frequency bioimpedance
Change in food craving Week 0 and 4 Food craving estimated from the questionnaire, Food Craving Inventory, on a 5 point likert scale
Three factor eating inventory Week 0 Three factor eating inventory questionnaire measured once. Instrument has three subscales, combining likert scales and true/false questions. Subscales include cognitive restraint (score can range from 0 to 21), disinhibition (score can range from 0 to 16) and hunger (score can range from 0 to 14).
Change in liver stiffness Week 0 and 4 Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®
Change in lean body mass Weeks 0, 1, 2, 3, and 4 measured in kg using multi frequency bioimpedance
Change in self-reported satiety Week 0 and 4 Self reported satiety measured using the 5-factor satiety questionnaire. Scale is a generalized labeled magnitude scale of 150 mm Subscales include mental hunger, physical hunger, mental fullness, physical fullness, and satiation. Subscale scores will range from 0 to 150.
Eating behavior Week 0 Dutch eating behavior questionnaire measured once. Scale is a 5-point likert scale. Sub scales include restrained eating, emotional eating, and external eating. Scores will be reported separately for each subscale.
Genetic risk of obesity Week 1 A polygenic risk score (PRS) indexing genetic predisposition to obesity using known obesity single nucleotide polymorphisms (SNPs).
Change in liver fat Week 0 and 4 Liver fat assessed from the Controlled Attenuation Parameter (CAP) computed from the liver stiffness measurement using the Fibroscan®
Power of food questionnaire Week 0 Power of food questionnaire measured once on a 5 point likert scale
Change in dietary intake Ten dietary recalls collected at home during weeks 1-4 Dietary intake estimated from 24-hour recall using a web based automated multi-pass method
Change in metabolic rate Baseline and 1 hour before lunch meal, 1 hour after lunch meal, and 1 hour after mid-afternoon snack Resting and post-prandial metabolic rate measured using indirect calorimetry.
Usual physical activity Week 0 Physical activity estimated from the Stanford Brief Physical Activity questionnaire. Scale is categorical for two subscales: work physical activity and leisure time activity.
General health and well-being Week 0 The SF-36 General Health and Well-being questionnaire measured once
Trial Locations
- Locations (1)
USDA, ARS, Western Human Nutrition Research Center
🇺🇸Davis, California, United States