- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02935829
Short-term Effects of a Carob Snack on Postprandial Glycemic Responses and Energy Intake and Satiety
January 19, 2017 updated by: Aimilia Papakonstantinou, Agricultural University of Athens
Short-term Effects of a Low Glycemic Index Snack Including Carob on Postprandial Glycemic Responses, Energy Intake and Satiety in Normal-weight, Healthy Adults
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.
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Athens, Greece, 11855
- Agricultural University of Athens
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Glucose as reference food
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 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.
|
|
Experimental: Carob preload
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).
|
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.
|
|
Experimental: White bread as reference food
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 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.
|
|
Experimental: Carob snack as test food
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 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.
|
|
Experimental: Chocolate cookie snack as test food
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 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.
|
|
Experimental: Chocolate cookie preload
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Capillary blood glucose and subjective appetite ratings
Time Frame: 7 hours
|
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
|
7 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective appetite ratings
Time Frame: 6 hours
|
Useful change in subjective appetite (hunger, desire to eat, motivation to eat, preoccupation with thoughts of food, thirst) scores from 100mm VAS
|
6 hours
|
|
Energy intake after preload
Time Frame: 2 hours
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Useful change in energy intake the day of the intervention (actual weighing of foods consumed and leftovers and 24hr recall)
|
2 hours
|
|
Energy intake next 24hours
Time Frame: 2 days
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Useful change in energy intake in the next 24hr (24hr recall) after intervention
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
May 24, 2016
First Submitted That Met QC Criteria
October 14, 2016
First Posted (Estimate)
October 18, 2016
Study Record Updates
Last Update Posted (Estimate)
January 20, 2017
Last Update Submitted That Met QC Criteria
January 19, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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