Snacks and Satiety

NCT03947281 | Terminated

• 1 other identifier: FL107
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Behavior; Overweight; Obesity

Keywords

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

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (22)

• Body composition reference measurement

  Week 1

• Change in body weight

  Weeks 0, 1, 2, 3, and 4

• Change in body fat

  Weeks 0, 1, 2, 3, and 4

• Change in lean body mass

  Weeks 0, 1, 2, 3, and 4

• Change in total body water

  Weeks 0, 1, 2, 3, and 4

Study Arms (2)

Almond snack

EXPERIMENTAL

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

Other: Almond snack

Cereal-based snack

EXPERIMENTAL

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

Interventions

Almond snack OTHER

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

Almond snack

Cereal-based snack OTHER

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.

Cereal-based snack

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-menopausal
• Body Mass Index 25 - 39.9 kg/m2

You may not qualify if:

• 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).

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead
• Almond Board of California: collaborator

Study Sites (1)

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Feeding Behavior; Overweight; Obesity

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: June 24, 2019
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)