Postprandial Glucose, Insulin and Subjective Saturation Response in Healthy Individuals

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Individuals; Grain-Like Products; Postprandial Glucose; Plasma Insulin; Subjective Saturation Response
• Intervention / Treatment: Dietary supplement: Flaxseed and Chia

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Özlem ÖZPAK AKKUŞ, PhD; Phone Number: +905051397978; Email: dytozlemozpak@hotmail.com

Study Locations

• Turkey
  • Mersin, Turkey, 33040
    • Recruiting
    • Özlem ÖZPAK AKKUŞ
    • Contact: Özlem ÖZPAK AKKUŞ; Phone Number: 05051397978; Email: dytozlemozpak@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Nutritional analyzes applied to four 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.
Experimental: Flaxseed cake; Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed cake	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
Experimental: Chia cake; Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of chia cake	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
Experimental: Flaxseed and chia cake; Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed and chia cake	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
Experimental: Standart; Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of standart cake	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Toros University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): June 19, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Insulin; Carbohydrate; Appetite; Blood glucose; Flaxseed; Chia
• Other Study ID Numbers: ChiaFlaxseed

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared with permission of principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No