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Snacks and Satiety

Primary Purpose

Eating Behavior, Overweight, Obesity

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Almond snack

Cereal-based snack

About this trial

This is an interventional basic science trial for Eating Behavior focused on measuring satiety, gastrointestinal hormones, appetite, Dietary fiber, food cravings

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

USDA, ARS, Western Human Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Almond snack

Cereal-based snack

Arm Description

The almond intervention will be roasted almonds 56 grams/day for 28 days. The caloric value is approximately 350 kcals.

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.

Outcomes

Primary Outcome Measures

Baseline level and change in cholecystokinin

Cholecystokinin (CCK) measured in blood using an antibody based assay

Baseline level and change in peptide-YY

Peptide-YY (PYY) measured in blood using an antibody based assay

Baseline level and change in glucose-like peptide 1

Glucose-like peptide 1 (GLP-1) measured in blood using an antibody based assay

Baseline level and change in gastric inhibitory peptide

Gastric inhibitory peptide (GIP) measured in blood using an antibody based assay

Baseline level and change in insulin

Insulin measured in blood using an antibody based assay

Baseline level and change in glucose

Glucose measured by standard chemistry in blood

Baseline level and change in oleoylethanolamide

Oleoylethanolamide measured by mass spectrometry in blood

Baseline level and change in ghrelin

Ghrelin measured in blood using an antibody based assay

Baseline level and change in leptin

Leptin measured in blood using an antibody based assay

Baseline level and change in orexin

Orexin measured in blood using an antibody based assay

Baseline level and change in endocannabinoid profiles

Endocannabinoid profiles measured by mass spectrometry in blood

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 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."

Change in food intake at a dinner meal

Calories consumed at a dinner meal following the satiety protocol

Secondary Outcome Measures

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)

Change in body weight

measured in kg

Change in body fat

measured in kg using multi frequency bioimpedance

Change in lean body mass

measured in kg using multi frequency bioimpedance

Change in total body water

measured in kg using multi frequency bioimpedance

Change in waist circumference

measured in cm

Change in hip circumference

measured in cm

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.

Change in food craving

Food craving estimated from the questionnaire, Food Craving Inventory, on a 5 point likert scale

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.

Power of food questionnaire

Power of food questionnaire measured once on a 5 point likert scale

Food addiction questionnaire

Yale food addiction questionnaire measured once on a 5-point likert scale

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.

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).

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.

General health and well-being

The SF-36 General Health and Well-being questionnaire measured once

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.

Change in metabolic rate

Resting and post-prandial metabolic rate measured using indirect calorimetry.

Change in dietary intake

Dietary intake estimated from 24-hour recall using a web based automated multi-pass method

Genetic risk of obesity

A polygenic risk score (PRS) indexing genetic predisposition to obesity using known obesity single nucleotide polymorphisms (SNPs).

Change in liver fat

Liver fat assessed from the Controlled Attenuation Parameter (CAP) computed from the liver stiffness measurement using the Fibroscan®

Change in liver stiffness

Liver stiffness assessed from the shear wave speed with pulse echo ultrasound using the Fibroscan®

Full Information

NCT ID

NCT03947281

First Posted

May 9, 2019

Last Updated

August 8, 2022

Sponsor

USDA, Western Human Nutrition Research Center

Collaborators

Almond Board of California

1. Study Identification

Unique Protocol Identification Number

NCT03947281

Brief Title

Snacks and Satiety

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

After delay due to pandemic, sponsor declined to continue funding.

Study Start Date

June 24, 2019 (Actual)

Primary Completion Date

August 8, 2022 (Actual)

Study Completion Date

August 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

USDA, Western Human Nutrition Research Center

Collaborators

Almond Board of California

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eating Behavior, Overweight, Obesity

Keywords

satiety, gastrointestinal hormones, appetite, Dietary fiber, food cravings

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

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.

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Almond snack

Arm Type

Experimental

Arm Description

The almond intervention will be roasted almonds 56 grams/day for 28 days. The caloric value is approximately 350 kcals.

Arm Title

Cereal-based snack

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Almond snack

Intervention Description

The almond intervention will be roasted, unsalted almonds provided at 56 g/day for 28 days. Almonds provide approximately 350 kcals/day.

Intervention Type

Other

Intervention Name(s)

Cereal-based snack

Intervention Description

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.

Primary Outcome Measure Information:

Title

Baseline level and change in cholecystokinin

Description

Cholecystokinin (CCK) measured in blood using an antibody based assay

Time Frame