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

Potential Abnormality of Glucose Tolerance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935829
• Other study ID #: 304
• Status: Completed
• Phase: N/A
• First received: May 24, 2016
• Last updated: January 19, 2017
• Start date: March 2014
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Agricultural University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Glucose as reference food
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.
• White bread as reference food
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.
• Carob snack as test food
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.
• Chocolate cookie snack as test food
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.
• Carob preload
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.
• Chocolate cookie preload
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.

Locations

Country	Name	City	State
Greece	Agricultural University of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Agricultural University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 hours
Secondary	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	6 hours
Secondary	Energy intake after preload	Useful change in energy intake the day of the intervention (actual weighing of foods consumed and leftovers and 24hr recall)	2 hours
Secondary	Energy intake next 24hours	Useful change in energy intake in the next 24hr (24hr recall) after intervention	2 days