Snacks and Satiety

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

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 Overview

• Status: Terminated
• Conditions: Obesity; Overweight; Eating Behavior
• Intervention / Treatment: Other: Almond snack; Other: Cereal-based snack

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • USDA, ARS, Western Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Almond snack; The almond intervention will be roasted almonds 56 grams/day for 28 days. The caloric value is approximately 350 kcals.	Other: Almond snack; The almond intervention will be roasted, unsalted almonds provided at 56 g/day for 28 days. Almonds provide approximately 350 kcals/day.
Experimental: 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.	Other: Cereal-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline level and change in cholecystokinin	Cholecystokinin (CCK) measured in blood using an antibody based assay	Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in peptide-YY	Peptide-YY (PYY) measured in blood using an antibody based assay	Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in glucose-like peptide 1	Glucose-like peptide 1 (GLP-1) measured in blood using an antibody based assay	Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in gastric inhibitory peptide	Gastric inhibitory peptide (GIP) measured in blood using an antibody based assay	Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in insulin	Insulin measured in blood using an antibody based assay	Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in glucose	Glucose measured by standard chemistry in blood	Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in oleoylethanolamide	Oleoylethanolamide measured by mass spectrometry in blood	Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in ghrelin	Ghrelin measured in blood using an antibody based assay	Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in leptin	Leptin measured in blood using an antibody based assay	Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in orexin	Orexin measured in blood using an antibody based assay	Baseline, 60 minutes before lunch meal, and 10, 30, 90, 150, 180, 210, 240, and 270 minutes after a lunch meal
Baseline level and change in endocannabinoid profiles	Endocannabinoid profiles measured by mass spectrometry in blood	Baseline, 60 minutes before lunch meal, and 10, 30, and 150 minutes after a lunch meal
Baseline level and change in hunger	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, every 30 minutes up to 480 minutes, and immediately before and after three meals
Baseline level and change in satiety	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."	Baseline, every 30 minutes up to 480 minutes, and immediately before and after three meals
Change in food intake at a dinner meal	Calories consumed at a dinner meal following the satiety protocol	Week 1 and 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition reference measurement	Body composition (fat mass and fat-free mass in kg) will be measured once during the study using dual energy x-ray absorptiometry (DEXA)	Week 1
Change in body weight	measured in kg	Weeks 0, 1, 2, 3, and 4
Change in body fat	measured in kg using multi frequency bioimpedance	Weeks 0, 1, 2, 3, and 4
Change in lean body mass	measured in kg using multi frequency bioimpedance	Weeks 0, 1, 2, 3, and 4
Change in total body water	measured in kg using multi frequency bioimpedance	Weeks 0, 1, 2, 3, and 4
Change in waist circumference	measured in cm	Week 0 and 4
Change in hip circumference	measured in cm	Week 0 and 4
Change in Food Choice	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.	Baseline and following a lunch meal at Weeks 0 and 4
Change in food craving	Food craving estimated from the questionnaire, Food Craving Inventory, on a 5 point likert scale	Week 0 and 4
Change in self-reported satiety	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.	Week 0 and 4
Power of food questionnaire	Power of food questionnaire measured once on a 5 point likert scale	Week 0
Food addiction questionnaire	Yale food addiction questionnaire measured once on a 5-point likert scale	Week 0
Eating behavior	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.	Week 0
Three factor eating inventory	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).	Week 0
Premenstrual Syndrome	Premenstrual Syndrome screening questionnaire measured once. Scale is a 4-point likert. Subscales for premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD), reported separately.	Week 0
General health and well-being	The SF-36 General Health and Well-being questionnaire measured once	Week 0
Usual physical activity	Physical activity estimated from the Stanford Brief Physical Activity questionnaire. Scale is categorical for two subscales: work physical activity and leisure time activity.	Week 0
Change in metabolic rate	Resting and post-prandial metabolic rate measured using indirect calorimetry.	Baseline and 1 hour before lunch meal, 1 hour after lunch meal, and 1 hour after mid-afternoon snack
Change in dietary intake	Dietary intake estimated from 24-hour recall using a web based automated multi-pass method	Ten dietary recalls collected at home during weeks 1-4
Genetic risk of obesity	A polygenic risk score (PRS) indexing genetic predisposition to obesity using known obesity single nucleotide polymorphisms (SNPs).	Week 1
Change in liver fat	Liver fat assessed from the Controlled Attenuation Parameter (CAP) computed from the liver stiffness measurement using the Fibroscan®	Week 0 and 4
Change in liver stiffness	Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®	Week 0 and 4

Collaborators and Investigators

• Sponsor: USDA, Western Human Nutrition Research Center
• Collaborators: Almond Board of California

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): August 8, 2022
• Study Completion (Actual): August 8, 2022

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: appetite; satiety; Dietary fiber; gastrointestinal hormones; food cravings
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: FL107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No