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Short-term Effects of a Carob Snack on Postprandial Glycemic Responses and Energy Intake and Satiety

Primary Purpose

Potential Abnormality of Glucose Tolerance, Appetite; Lack or Loss, Nonorganic Origin

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Glucose as reference food
White bread as reference food
Carob snack as test food
Chocolate cookie snack as test food
Carob preload
Chocolate cookie preload
Sponsored by
Agricultural University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Potential Abnormality of Glucose Tolerance focused on measuring energy intake, blood glucose, carob flour

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Healthy, non-smoking, non-diabetic men and women individuals with normal body mass index (BMI; between 18.5 and 24.9 kg/m2)

Exclusion Criteria:

  • Severe chronic disease (e.g. tumors, manifest coronary heart disease, diabetes mellitus, severe kidney or liver conditions, endocrine and immunological conditions)
  • Gastrointestinal disorders (e.g. chronic inflammatory bowel disease)
  • Lactose intolerance
  • Pregnancy
  • Competitive sports
  • Lactation
  • Alcohol
  • Drug dependency

Sites / Locations

  • Agricultural University of Athens

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Glucose as reference food

Carob preload

White bread as reference food

Carob snack as test food

Chocolate cookie snack as test food

Chocolate cookie preload

Arm Description

Ten healthy, normal-weight subjects (male: 6, female: 4) after 10-14 hr fast, consumed 25g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from carob snack and chocolate cookie, one time, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Fifty healthy subjects (male: 22, female: 28) were offered a standardized breakfast and 2h after consumed one of the two preloads (carob snack and chocolate cookie) served as snack in random order. Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). Foods were weighed at the time of serving and any leftovers were weighed again after meal to determine the amount of food consumed. Fingertip capillary blood glucose samples were collected before and after foods. Subjective appetite ratings were collected using 100mm visual analogue scales (VAS).

Ten healthy, normal-weight subjects (male: 6, female: 4) after 10-14 hr fast, consumed 25g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from carob snack and chocolate cookie, one time, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Ten healthy, normal-weight subjects (male: 6, female: 4) after 10-14 hr fast, consumed 25g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from carob snack and chocolate cookie, one time, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Ten healthy, normal-weight subjects (male: 6, female: 4) after 10-14 hr fast, consumed 25g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from carob snack and chocolate cookie, one time, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Fifty healthy subjects (male: 22, female: 28) were offered a standardized breakfast and 2h after consumed one of the two preloads (carob snack and chocolate cookie) served as snack in random order. Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). Foods were weighed at the time of serving and any leftovers were weighed again after meal to determine the amount of food consumed. Fingertip capillary blood glucose samples were collected before and after foods. Subjective appetite ratings were collected using 100mm visual analogue scales (VAS).

Outcomes

Primary Outcome Measures

Capillary blood glucose and subjective appetite ratings
Clinically useful change in serum glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test. Useful change in subjective appetite (hunger, desire to eat, motivation to eat, preoccupation with thoughts of food, thirst) scores from 100mm VAS

Secondary Outcome Measures

Subjective appetite ratings
Useful change in subjective appetite (hunger, desire to eat, motivation to eat, preoccupation with thoughts of food, thirst) scores from 100mm VAS
Energy intake after preload
Useful change in energy intake the day of the intervention (actual weighing of foods consumed and leftovers and 24hr recall)
Energy intake next 24hours
Useful change in energy intake in the next 24hr (24hr recall) after intervention

Full Information

First Posted
May 24, 2016
Last Updated
January 19, 2017
Sponsor
Agricultural University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT02935829
Brief Title
Short-term Effects of a Carob Snack on Postprandial Glycemic Responses and Energy Intake and Satiety
Official Title
Short-term Effects of a Low Glycemic Index Snack Including Carob on Postprandial Glycemic Responses, Energy Intake and Satiety in Normal-weight, Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Agricultural University of Athens

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study investigated any potential associations between two preloads offered as snacks and postprandial glycemic response, subjective and objective appetite and energy intake in healthy, normal-weight adults.
Detailed Description
This study aimed at 1. firstly determine the glycemic index (GI) of a carob snack compared with an isoenergetic, equal weight chocolate cookie and 2. test the hypothesis that a carob preload consumed as snack before a meal, compared to chocolate cookie would: (a) have greater short-term effect on satiety measured by subsequent ad libitum meal intake, (b) induce greater satiety as assessed by visual analogue scales (VAS), and (c) reduce postprandial glycemic response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Potential Abnormality of Glucose Tolerance, Appetite; Lack or Loss, Nonorganic Origin
Keywords
energy intake, blood glucose, carob flour

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose as reference food
Arm Type
Experimental
Arm Description
Ten healthy, normal-weight subjects (male: 6, female: 4) after 10-14 hr fast, consumed 25g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from carob snack and chocolate cookie, one time, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Arm Title
Carob preload
Arm Type
Experimental
Arm Description
Fifty healthy subjects (male: 22, female: 28) were offered a standardized breakfast and 2h after consumed one of the two preloads (carob snack and chocolate cookie) served as snack in random order. Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). Foods were weighed at the time of serving and any leftovers were weighed again after meal to determine the amount of food consumed. Fingertip capillary blood glucose samples were collected before and after foods. Subjective appetite ratings were collected using 100mm visual analogue scales (VAS).
Arm Title
White bread as reference food
Arm Type
Experimental
Arm Description
Ten healthy, normal-weight subjects (male: 6, female: 4) after 10-14 hr fast, consumed 25g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from carob snack and chocolate cookie, one time, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Arm Title
Carob snack as test food
Arm Type
Experimental
Arm Description
Ten healthy, normal-weight subjects (male: 6, female: 4) after 10-14 hr fast, consumed 25g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from carob snack and chocolate cookie, one time, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Arm Title
Chocolate cookie snack as test food
Arm Type
Experimental
Arm Description
Ten healthy, normal-weight subjects (male: 6, female: 4) after 10-14 hr fast, consumed 25g available carbohydrate from white bread and glucose, two times, in different weeks as reference foods along with 250ml water; and 25g available carbohydrates from carob snack and chocolate cookie, one time, in different weeks along with 250ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Arm Title
Chocolate cookie preload
Arm Type
Experimental
Arm Description
Fifty healthy subjects (male: 22, female: 28) were offered a standardized breakfast and 2h after consumed one of the two preloads (carob snack and chocolate cookie) served as snack in random order. Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). Foods were weighed at the time of serving and any leftovers were weighed again after meal to determine the amount of food consumed. Fingertip capillary blood glucose samples were collected before and after foods. Subjective appetite ratings were collected using 100mm visual analogue scales (VAS).
Intervention Type
Other
Intervention Name(s)
Glucose as reference food
Intervention Description
Ten subjects (male: 6, female: 4) consumed 25g glucose diluted in 250ml water, two times, in different weeks, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
Intervention Type
Other
Intervention Name(s)
White bread as reference food
Intervention Description
Ten subjects (male: 6, female: 4) consumed 25g available carbohydrate from white bread along with 250ml water, two times, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
Intervention Type
Other
Intervention Name(s)
Carob snack as test food
Intervention Description
Ten subjects (male: 6, female: 4) consumed 25g available carbohydrate from carob snack along with 250ml water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
Intervention Type
Other
Intervention Name(s)
Chocolate cookie snack as test food
Intervention Description
Ten subjects (male: 6, female: 4) consumed 25g available carbohydrate from chocolate cookie snack along with 250ml water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
Intervention Type
Other
Intervention Name(s)
Carob preload
Intervention Description
Fifty healthy subjects (male: 22, female: 28) consumed a standardized breakfast (bread and honey) and 2h after were offered a preload given as snack (40g carob snack). Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). The meal consisted of rice, roasted chicken breast and chocolate cake. Foods were weighed before serving and any leftovers were weighed again after meal. Fingertip capillary blood glucose samples were taken before breakfast, 120min after breakfast; before preload, 120minand 180minpost-preload consumption; before meal (lunch and dessert), 60minand 120min post-meal consumption. Subjective appetite ratings were assessed with 100mm VAS.
Intervention Type
Other
Intervention Name(s)
Chocolate cookie preload
Intervention Description
Fifty healthy subjects (male: 22, female: 28) consumed a standardized breakfast (bread and honey) and 2h after were offered a preload given as snack (40g chocolate cookie). Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). The meal consisted of rice, roasted chicken breast and chocolate cake. Foods were weighed before serving and any leftovers were weighed again after meal. Fingertip capillary blood glucose samples were taken before breakfast, 120min after breakfast; before preload, 120minand 180minpost-preload consumption; before meal (lunch and dessert), 60minand 120min post-meal consumption. Subjective appetite ratings were assessed with 100mm VAS.
Primary Outcome Measure Information:
Title
Capillary blood glucose and subjective appetite ratings
Description
Clinically useful change in serum glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test. Useful change in subjective appetite (hunger, desire to eat, motivation to eat, preoccupation with thoughts of food, thirst) scores from 100mm VAS
Time Frame
7 hours
Secondary Outcome Measure Information:
Title
Subjective appetite ratings
Description
Useful change in subjective appetite (hunger, desire to eat, motivation to eat, preoccupation with thoughts of food, thirst) scores from 100mm VAS
Time Frame
6 hours
Title
Energy intake after preload
Description
Useful change in energy intake the day of the intervention (actual weighing of foods consumed and leftovers and 24hr recall)
Time Frame
2 hours
Title
Energy intake next 24hours
Description
Useful change in energy intake in the next 24hr (24hr recall) after intervention
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Healthy, non-smoking, non-diabetic men and women individuals with normal body mass index (BMI; between 18.5 and 24.9 kg/m2) Exclusion Criteria: Severe chronic disease (e.g. tumors, manifest coronary heart disease, diabetes mellitus, severe kidney or liver conditions, endocrine and immunological conditions) Gastrointestinal disorders (e.g. chronic inflammatory bowel disease) Lactose intolerance Pregnancy Competitive sports Lactation Alcohol Drug dependency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimilia Papakonstantinou, PhD
Organizational Affiliation
Agricultural University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Agricultural University of Athens
City
Athens
ZIP/Postal Code
11855
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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Short-term Effects of a Carob Snack on Postprandial Glycemic Responses and Energy Intake and Satiety

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