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Completed

NCT Number: NCT05484323

Acute Effects of Cookies Containing 2.5 g Spirulina on Postprandial Glycemic and Insulin Responses

This study investigated the effects of cookies containing 2.5 g Spirulina on postprandial glycemic and insulin responses.

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Key information

Conditions

Potential Abnormality of Glucose Tolerance Appetitive Behavior Behavior Behavior, Animal Blood Pressure

Age range

18 year–55 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 examined the short-term effects of cookies containing 0 and 2.5 g Spirulina on postprandial glycemic and insulin responses, arterial blood pressure and subjective appetite

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy
  • non-smoking
  • men and women
  • body mass index between 18 and 24.9 kg/m2

Exclusion criteria

  • severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endrocrine conditions)
  • gastrointestinal diseases
  • pregnancy
  • lactation
  • competitive sports
  • alcohol abuse
  • drug dependency

Treatment and study plan

Glucose as reference food

Other

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

White Bread

Other

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

Cookie containing 0 g spirulina

Diagnostic Test

Thirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

Cookie containing 2.5 g spirulina

Other

TThirteen healthy participants (male: 4, female: 9) after 10-14h fast, consumed 50 g available carbohydrates from D-glucose, in different visits as reference food, tested two times; and 50 g available carbohydrates from white bread, tested two times; and 50 g available carbohydrates from cookies containing 0 and 2.5g spirulina, tested once, in different visits, along with 250 mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose and salivary insulin samples were taken at 0, 15, 30, 45, 60, 90 and 120 min postmeal. The first glucose and salivary insulin sample were taken exactly 15 min after the first bite of food or drink.

Primary outcomes

  1. Capillary blood glucose responses

    Time frame: 2 hours

    Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2 hr glucose tolerance test

Secondary outcomes

  1. Salivary insulin responses

    Time frame: 2 hours

    Clinically useful change in salivary insulin, defined as the restoration of insulin within normal limits during the 2hr glucose tolerance test

Other outcomes

  1. Subjective appetite ratings

    Time frame: 2 hours

    Useful change in subjective appetite using visual analogue scales with a score 0 to 10 (given in the form of booklet, one scale per page) at baseline, 15, 30, 45, 60, 90 and 120min. The minimum or maximum score will be evaluated if it is better or worse depending on the appetite variable e.g. hunger, satiety, desire to eat etc

  2. Blood pressure

    Time frame: 2 hours

    Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the cookie products

Sponsors and collaborators

Lead sponsor

Agricultural University of Athens

Other

Registry information

Official study title

Acute Effects of Cookies Containing 2.5 g Spirulina on Postprandial Glycemic and Insulin Responses: A Randomized Clinical Trial in Healthy Humans

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 2, 2022
Registry last updated
Aug 2, 2022

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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