Postprandial Glucose, Insulin and Subjective Saturation Response in Healthy Individuals

Not Applicable

• Conditions: Grain-Like Products; Postprandial Glucose; Plasma Insulin; Subjective Saturation Response; Healthy Individuals
• Interventions: Dietary Supplement: Flaxseed and Chia

• Registration Number: NCT05358561
• Lead Sponsor: Toros University

Brief 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.

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 Timeline

• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-04-27
• Study Start: 2022-05-01
• Study First Posted: 2022-05-03
• Status Verified: 2022-06
• Primary Completion: 2022-06-19
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-23
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Flaxseed cake	Flaxseed and Chia	Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed cake
Chia cake	Flaxseed and Chia	Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of chia cake
Flaxseed and chia cake	Flaxseed and Chia	Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed and chia cake
Standart	Flaxseed and Chia	Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of standart cake

Primary Outcome Measures

Name	Time	Method
Flax Seed Cake and Satiety Response Measurements	One day	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.
Chia Cake and Blood Glucose Parameters	One day	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.
Chia Cake and Plasma Insulin Levels	One day	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.
Flax Seed and Chia Cake and Plasma Insulin Levels	One day	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.
Standart Cake and Plasma Insulin Levels	One day	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.
Flax Seed Cake and Blood Glucose Parameters	One day	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.
Standart Cake and Blood Glucose Parameters	One day	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.
Flax Seed Cake and Plasma Insulin Levels	One day	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.
Chia Cake and Satiety Response Measurements	One day	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.
Standart Cake and Satiety Response Measurements	One day	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.
Flax Seed and Chia Cake and Blood Glucose Parameters	One day	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.

Trial Locations

Locations (1)

Özlem ÖZPAK AKKUŞ; 🇹🇷 Mersin, Turkey