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Mid-morning Gel Snacks on Subjective Appetite, Glycemic and Insulin Responses, and Food Intake

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ClinicalTrials.gov Identifier: NCT03207607
Recruitment Status : Completed
First Posted : July 5, 2017
Last Update Posted : July 5, 2017
Sponsor:
Collaborator:
The Hershey Company
Information provided by (Responsible Party):
Nick Bellissimo, Ryerson University

Brief Summary:
The purpose of this study was to determine the effect of mid-morning gel snacks on subjective appetite, glucose and insulin responses, and food intake in healthy weight young adults.

Condition or disease Intervention/treatment Phase
Satiety Food Intake Other: Control snack Other: Maltodextrin snack Other: Whey protein snack Other: Oat snack Other: Coconut oil snack Other: Snack skipping Not Applicable

Detailed Description:
23 (14 male, 9 female) healthy, non-smoking human subjects aged 18-30 years with a body mass index (BMI) between 20 and 24.9 were recruited in the experiment. Five gel snacks including a control snack and four modified snacks containing whey protein, oats, coconut oil or maltodextrin were tested. On six separate mornings, at least 3 days apart and after a 12 hours overnight fast, each participant consumed a standardized breakfast of cereal, milk, and orange juice at home, then arrived in the lab 2 hours after breakfast to receive one of the five test snack treatments or skip snack. Subjective appetite by a 100 mm visual analogue scale (VAS) was measured at baseline (0 min) and after each treatment up to 2 h (15, 30, 60, 90, and 120 min). Blood glucose and insulin concentrations were measured via finger-prick at the same time VAS measurements were taken. Food intake was measured via ad libitum pizza lunch.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Coded snacks in shaded tetrapaks were provided to participants
Primary Purpose: Prevention
Official Title: The Effect of Mid-Morning Gel Snacks on Subjective Appetite, Glycemic and Insulin Responses, and Food Intake in Healthy Adults
Actual Study Start Date : February 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Control snack
Participants received control snacks prepared by real fruits (pear, orange and mango)
Other: Control snack
Isovolumetric (238.4g) gel snack prepared by real fruits (186.2kcal)

Experimental: Maltodextrin snack
Participants received maltodextrin snacks (maltodextrin + control snack)
Other: Maltodextrin snack
Isovolumetric (238.4g) gel snack with maltodextrin (271.8kcal)

Experimental: Whey protein snack
Participants received whey protein snacks (whey protein + control snack)
Other: Whey protein snack
Isovolumetric (238.4g) gel snack with whey protein (201.8kcal)

Experimental: Oat snack
Participants received oat snacks (oat + maltodextrin + control snack)
Other: Oat snack
Isovolumetric (238.4g) gel snack with oats and maltodextrin (275.8kcal)

Experimental: Coconut oil snack
Participants received coconut oil snacks (coconut oil + control snack)
Other: Coconut oil snack
Isovolumetric (238.4g) gel snack with coconut oil (276.4kcal)

Experimental: Snack skipping
Participants received snack skipping
Other: Snack skipping
no snack




Primary Outcome Measures :
  1. Subjective Appetite [ Time Frame: Change from baseline over 120 minutes ]
    Participants completed subjective ratings on appetite (e.g., desire to eat, hunger, fullness, prospective food consumption) and well-being at baseline (0 min), 15, 30, 45, 60, 90, and 120 min after snack consumption, as well as immediately following lunch.


Secondary Outcome Measures :
  1. Blood Glucose Response [ Time Frame: Change from baseline over 120 minutes ]
    Blood was collected at baseline (0min), 15, 30, 45, 60, 90, and 120 min after snack consumption, as well as immediately following lunch to observe glycemic responses to gel snacks

  2. Blood Insulin Response [ Time Frame: Change from baseline over 120 minutes ]
    Blood was collected at baseline (0 min), 15, 30, 45, 60, 90, and 120 min after meal consumption, as well as immediately following lunch, to observe insulin responses to gel snacks

  3. Food Intake [ Time Frame: 30 min ]
    Participants consumed an ad libitum pizza lunch at 120 minutes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • be between 18 and 30 years of age
  • be healthy, non-smoking and not be taking any medications, including birth control
  • body mass index (BMI) between 20 and 24.9

Exclusion Criteria:

  • fasting plasma glucose >5.5 mmol/L
  • health problems including previously diagnosed diabetes, known or uncertain pregnancy status at screening, gastrointestinal disease, liver or kidney disease
  • major medical or surgical event within the past 6 months
  • current or recent dieting
  • breakfast skipping
  • receiving any medications
  • menstrual irregularities
  • food sensitivities, allergies, intolerances, or dietary restrictions to foods including: cereal, orange juice, dairy, oat, coconut oil, honey, apple, pineapple, strawberry, and pear
  • behavioural or emotional problems
  • alcohol consumption >7 beverages/week

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207607


Locations
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Canada, Ontario
School of Nutrition, Ryerson University
Toronto, Ontario, Canada, M5B 2K3
Sponsors and Collaborators
Ryerson University
The Hershey Company
Investigators
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Principal Investigator: Nick Bellissimo, PhD Ryerson University
Principal Investigator: Derick Rousseau, PhD Ryerson University

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Responsible Party: Nick Bellissimo, PhD, Ryerson University
ClinicalTrials.gov Identifier: NCT03207607     History of Changes
Other Study ID Numbers: REB2015-405
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nick Bellissimo, Ryerson University:
Adults
Snacks
Appetite
Blood glucose
Insulin
Additional relevant MeSH terms:
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Insulin
Hypoglycemic Agents
Physiological Effects of Drugs