Snacks and Satiety

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03947281
• Other study ID #: FL107
• Status: Terminated
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: August 8, 2022

Study information

• Verified date: August 2022
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 8, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Eating Behavior
• Obesity
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	USDA, ARS, Western Human Nutrition Research Center	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	Almond Board of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in food intake at a dinner meal	Calories consumed at a dinner meal following the satiety protocol	Week 1 and 4
Secondary	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
Secondary	Change in body weight	measured in kg	Weeks 0, 1, 2, 3, and 4
Secondary	Change in body fat	measured in kg using multi frequency bioimpedance	Weeks 0, 1, 2, 3, and 4
Secondary	Change in lean body mass	measured in kg using multi frequency bioimpedance	Weeks 0, 1, 2, 3, and 4
Secondary	Change in total body water	measured in kg using multi frequency bioimpedance	Weeks 0, 1, 2, 3, and 4
Secondary	Change in waist circumference	measured in cm	Week 0 and 4
Secondary	Change in hip circumference	measured in cm	Week 0 and 4
Secondary	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
Secondary	Change in food craving	Food craving estimated from the questionnaire, Food Craving Inventory, on a 5 point likert scale	Week 0 and 4
Secondary	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
Secondary	Power of food questionnaire	Power of food questionnaire measured once on a 5 point likert scale	Week 0
Secondary	Food addiction questionnaire	Yale food addiction questionnaire measured once on a 5-point likert scale	Week 0
Secondary	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
Secondary	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
Secondary	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
Secondary	General health and well-being	The SF-36 General Health and Well-being questionnaire measured once	Week 0
Secondary	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
Secondary	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
Secondary	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
Secondary	Genetic risk of obesity	A polygenic risk score (PRS) indexing genetic predisposition to obesity using known obesity single nucleotide polymorphisms (SNPs).	Week 1
Secondary	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
Secondary	Change in liver stiffness	Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®	Week 0 and 4