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

Not Applicable

Completed

• Conditions: Potential Abnormality of Glucose Tolerance; Appetite; Lack or Loss, Nonorganic Origin
• Interventions: Other: Glucose as reference food; Other: Chocolate cookie preload; Other: Carob preload; Other: White bread as reference food; Other: Carob snack as test food; Other: Chocolate cookie snack as test food

• Registration Number: NCT02935829
• Lead Sponsor: Agricultural University of Athens

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.

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2015-12
• Study First Submitted: 2016-05-24
• Study Completion: 2016-09
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-18
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucose as reference food	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.
Chocolate cookie preload	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).
Carob preload	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).
White bread as reference food	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.
Carob snack as test food	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.
Chocolate cookie snack as test food	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.

Primary Outcome Measures

Name	Time	Method
Capillary blood glucose and subjective appetite ratings	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

Secondary Outcome Measures

Name	Time	Method
Subjective appetite ratings	6 hours	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	2 hours	Useful change in energy intake the day of the intervention (actual weighing of foods consumed and leftovers and 24hr recall)
Energy intake next 24hours	2 days	Useful change in energy intake in the next 24hr (24hr recall) after intervention

Trial Locations

Locations (1)

Agricultural University of Athens; 🇬🇷 Athens, Greece