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Completed

NCT Number: NCT02935829

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Agricultural University of Athens

Athens, 11855, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose as reference food

Other

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

Other

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

Other

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

Other

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

Other

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

Other

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 outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Energy intake after preload

    Time frame: 2 hours

    Useful change in energy intake the day of the intervention (actual weighing of foods consumed and leftovers and 24hr recall)

  3. Energy intake next 24hours

    Time frame: 2 days

    Useful change in energy intake in the next 24hr (24hr recall) after intervention

Sponsors and collaborators

Lead sponsor

Agricultural University of Athens

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 18, 2016
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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