Eating Behavior, Obesity, Overweight
Conditions
Keywords
satiety, gastrointestinal hormones, appetite, Dietary fiber, food cravings
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.
Interventions
OTHERAlmond snack
The almond intervention will be roasted, unsalted almonds provided at 56 g/day for 28 days. Almonds provide approximately 350 kcals/day.
OTHERCereal-based snack
The 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.
Sponsors
Almond Board of California
USDA, Western Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
Both the investigator and the participant will be aware of the group assignment. The persons handling the data and statistics will not be aware of the group assignment.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| General health and well-being | Week 0 | The SF-36 General Health and Well-being questionnaire measured once |
| 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. |
| 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. |
| Power of food questionnaire | Week 0 | Power of food questionnaire measured once on a 5 point likert scale |
| 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® |
| 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 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 |
| Food addiction questionnaire | Week 0 | Yale food addiction questionnaire measured once on a 5-point likert scale |
| 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. |
| 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 |
| 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. |
| Change in body fat | Weeks 0, 1, 2, 3, and 4 | measured in kg using multi frequency bioimpedance |
| Change in lean body mass | Weeks 0, 1, 2, 3, and 4 | measured in kg using multi frequency bioimpedance |
| Change in total body water | Weeks 0, 1, 2, 3, and 4 | measured in kg using multi frequency bioimpedance |
| 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. |
| 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). |
Countries
United States
Outcome results
None listed