Postprandial Glucose, Insulin and Subjective Saturation Response in Healthy Individuals

Healthy Individuals Clinical Trial

Official title:

An Evaluation of the Effect of Grain-Like Products on Postprandial Glucose, Insulin and Subjective Saturation Response in Healthy Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05358561
• Other study ID #: ChiaFlaxseed
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: June 2022
• Source: Toros University
• Contact: Özlem ÖZPAK AKKUS, PhD
• Phone: +905051397978
• Email: dytozlemozpak[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a pioneering study in which the effect of the consumption of cakes produced with the addition of cereal-like products such as chia and flax seeds, which have high soluble fiber content, on blood glucose and insulin values, and the effect on the satiety response of individuals after consumption of cakes, will be a pioneer in many subjects.

As a result of the study, the relationships between the changes in the investigated parameters and the possible changes in these parameters will be revealed. The results obtained suggest that foods rich in soluble fiber such as chia and flaxseed and foods produced with the possible synergetic effect of chia and flaxseed are used in healthy and safe products suitable for our consumption habits, and that these products are both protective and protective against the development of complications such as obesity and type 2 diabetes, cardiovascular diseases. The investigators think that it may also play a role in preventing its progress.

Description:

The present study aimed to compare the effect of the consumption of the cake supplemented with cereal-like produces, such as chia or flaxseed, which have high soluble fiber content, on postprondial blood glucose and insulin values. It also aimed to evaluate its effect of individuals' saturation response after consumption, and to develop cake recipes involving chia and flax seed. The study is two-fold. In the preliminary study, the standard and test cakes (chia added cake, flax seed added cake, and chia+flax seed added cake) were developed and the amount of cake containing 50 g carbohydrate and the amount of moisture, ash, pulp, protein, fat, and digestible carbohydrate will be determined via analyses that will be carried at Toros University Food Chemistry Laboratory. Based on the results obtained, the amount of cakes containing 50 g digestible carbohydrate will be calculated and produced. In the main study, the effect of standard and test cakes containing 50 g digestible carbohydrates on postprandial blood glucose, insulin, and subjective saturation response will be investigated. The study will be conducted with 14 volunteers aged between 19 and years 64, with no acute or chronic disease, having a Body Mass Index (BMI) of 18.5-24.9 kg/m2, and with a Beck Depression Scale of 8 or less. Those using prescription drugs and/or fiber supplements, pregnant or lactating women, those consuming excessive alcohol (> 2 drinks/day), women in menstrual period, those having allergic reaction to chia or flaxseed will not be included in the study. Before the individuals are included in the study, anthropometric measurements will be taken, Beck Depression Scale will be administered in order to evaluate the depression status, and individuals will be informed about the purpose and content of the study, and signed Informed Consent Form will be obtained from all participants. The individuals participating in the study will come to the research center once a week for four weeks to consume the cakes. Individuals will stay hungry for 10-12 hours after eating their usual dinner the night before the test and they will only consume water during this period. Baseline/fasting appetite responses of the individuals who came to the research center after this fasting period will be measured with a 100-mm visual analog scale (VAS) and baseline/fasting blood samples will be taken. The cakes will be consumed within 10 minutes and appetite responses will be measured using the 100-mm Visual Analog Scala (VAS) at 15, 30, 60, 90, 120, 180 minutes, and then venous blood samples will be taken by the nurse-in-charge. During this three-hour period, the participants will not be allowed to leave the research center, nor will they be allowed to consume any other food. Blood samples will be analyzed at the Forum Yaşam Hospital Biochemistry Laboratory. Glucose values will be analyzed by UV test analysis and insulin values will be analyzed by the chemical immunoassay method. The data obtained will be compared with the appropriate statistical methods and interpreted in the light of the literature.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: September 1, 2022
• Est. primary completion date: June 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria:

• The study will be conducted with 14 volunteers

• Aged between 19 and years 64

• No acute or chronic disease

• Body Mass Index (BMI) of 18.5-24.9 kg/m2

• Beck Depression Scale of 8 or less.

Exclusion Criteria:

• Using prescription drugs and/or fiber supplements

• Pregnant or lactating women

• Consuming excessive alcohol (> 2 drinks/day)

• Women in menstrual period

• Having allergic reaction to chia or flaxseed

Related Conditions & MeSH terms

• Healthy Individuals

Intervention

Dietary Supplement:
• Flaxseed and Chia
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes

Locations

Country	Name	City	State
Turkey	Özlem ÖZPAK AKKUS	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Toros University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nutritional analysis of flax seed, chia, flax seed + chia cake and standart cakes	The study is two-fold. In the preliminary study, the standard and test cakes (chia added cake, flax seed added cake, and chia+flax seed added cake) were developed and the amount of cake containing 50 g carbohydrate and the amount of moisture, ash, pulp, protein, fat, and digestible carbohydrate will be determined via analyses that will be carried at Toros University Food Chemistry Laboratory. Based on the results obtained, the amount of cakes containing 50 g digestible carbohydrate will be calculated and produced.	Five days
Primary	Flax Seed Cake and Blood Glucose Parameters	Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed cake.	One day
Primary	Flax Seed Cake and Plasma Insulin Levels	Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed cake.	One day
Primary	Flax Seed Cake and Satiety Response Measurements	Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed cake.	One day
Primary	Chia Cake and Blood Glucose Parameters	Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of chia cake.	One day
Primary	Chia Cake and Plasma Insulin Levels	Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of chia cake.	One day
Primary	Chia Cake and Satiety Response Measurements	Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of chia cake.	One day
Primary	Flax Seed and Chia Cake and Blood Glucose Parameters	Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed and chia cake.	One day
Primary	Flax Seed and Chia Cake and Plasma Insulin Levels	Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed and chia cake.	One day
Primary	Flax Seed Cake and Satiety Response Measurements	Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed and chia cake.	One day
Primary	Standart Cake and Blood Glucose Parameters	Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of standart cake.	One day
Primary	Standart Cake and Plasma Insulin Levels	Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of standart cake.	One day
Primary	Standart Cake and Satiety Response Measurements	Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of standart cake.	One day