NCT05358561

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

June 23, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

April 22, 2022

Last Update Submit

June 22, 2022

Conditions

Grain-Like ProductsPostprandial GlucosePlasma InsulinSubjective Saturation ResponseHealthy Individuals

Keywords

CarbohydrateChiaFlaxseedBlood glucoseInsulinAppetite

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (1)

  • Nutritional analysis of flax seed, chia, flax seed + chia cake and standart cakes

    Five days

Study Arms (5)

Nutritional analyzes applied to four cakes

NO INTERVENTION

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.

Flaxseed cake

EXPERIMENTAL

Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed cake

Dietary Supplement: Flaxseed and Chia

Chia cake

EXPERIMENTAL

Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of chia cake

Dietary Supplement: Flaxseed and Chia

Flaxseed and chia cake

EXPERIMENTAL

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

Standart

EXPERIMENTAL

Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of standart cake

Dietary Supplement: Flaxseed and Chia

Interventions

Flaxseed and ChiaDIETARY_SUPPLEMENT

Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes

Chia cakeFlaxseed and chia cakeFlaxseed cakeStandart

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özlem ÖZPAK AKKUŞ

Mersin, 33040, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Interventions

Linseed OilSalvia hispanica seed extract

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Central Study Contacts

Özlem ÖZPAK AKKUŞ, PhD

CONTACT

+905051397978dytozlemozpak@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not know what type of bread to eat
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Cross over
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2022

First Posted

May 3, 2022

Study Start

May 1, 2022

Primary Completion

June 19, 2022

Study Completion

September 1, 2022

Last Updated

June 23, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Data can be shared with permission of principal investigator

Locations

TU(1)