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Trial registered on ANZCTR

Registration number

ACTRN12621001382864

Ethics application status

Approved

Date submitted

31/05/2021

Date registered

11/10/2021

Date last updated

11/10/2021

Date data sharing statement initially provided

11/10/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Resistant starch effects in subjects with diabetes

Scientific title

Effects of resistant starch from two sources on the glycemic variability, postprandial lipemia and appetite in subjects with type 2 diabetes

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1163-4254

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Diet and Nutrition

Other diet and nutrition disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

During each treatment phase of a crossover design, the following will be performed. On day 1, a continuous glucose monitoring system (CGMS) sensor will be inserted by an endocrinologist in the peri-umbilical area to evaluate interstitial glucose every fifth minute. From days 1 to 4, each participant will consume two daily beverages containing one of three different supplements for the randomly assigned treatment.
The three treatment arms are listed as follows:
1. Digestible maize starch (DMS) containing Amioca (Ingredion).
2. High amylose maize starch (HMS) containing Hi-Maize 260 (Ingredion).
3. Native banana starch (NBS) containing NBS and Amioca.
All supplements will be matched by available carbohydrates (26.6 g), and the content of resistant starch (RS) in both HMS and NBS will be 40 g each. Beverages will be consumed at fasting state (7:00- 9:00 AM) and with lunch (13:00-15:00 PM). The study product will be provided in individual packaged, ready-to-use sachets to be mixed with a favorite drink in the blender at home. Compliance will be assessed by counting unopened sachets and by a query regarding the missed servings.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Digestible maize starch (DMS) supplement containing Amioca (100% rapidly resistant starch, RDS). RDS = 26.6 g ; Resistant starch content = 0 g

Control group

Placebo

Outcomes

Primary outcome [1]

Glycemic variability as measured by 4-day continuous glucose monitoring. 24h Incremental Area Under Curve (24h-iAUC), 24h Mean Blood glucose (24h-MBG)., Standard deviation (SD), Coefficient of Variation CV%, mean amplitude of glycaemic excursion (MAGE), Continuous overall Net Glycemic Action (CONGA) and Mean Absolute Glucose (MAG).

Timepoint [1]

The continuous glucose monitoring will begin on day 1 before the administration of the supplements and will be extended until day 5 of the experimental period. Determinations of the intersticial glucose concentrations will be determined every 5 min by this tool.

Secondary outcome [1]

The glycemic response will be determined during a 6h meal tolerance test (MTT). On day 5, a 6-h Meal Tolerance Test (MTT) will be carried out. An intravenous catheter will be inserted into the antecubital vein of all subjects. Thereafter, blood samples will be drawn at 0, 30, 60, 90, 120, 150, 180, 240, 300, and 360 min after consuming a standardized breakfast.

Timepoint [1]

During the meal tolerance test (MTT) performed on day 5 post-intervention. Timepoints at 0,30,60,90,120,150, 180 and 360 min after consuming the standardized breakfast.

Secondary outcome [2]

The insulinemic response will be determined during a 6h meal tolerance test (MTT). On day 5, a 6-h Meal Tolerance Test (MTT) will be carried out. An intravenous catheter will be inserted into the antecubital vein of all subjects. Thereafter, blood samples will be drawn at 0, 30, 60, 90, 120, 150, 180, 240, 300, and 360 min after consuming a standardized breakfast.

Timepoint [2]

During the meal tolerance test (MTT) performed on day 5 post-intervention. Timepoints at 0,30,60,90,120,150, 180 and 360 min after consuming the standardized breakfast.

Secondary outcome [3]

Subjective Appetite Assessment using a Visual Analogue Scale (VAS).

Timepoint [3]

Measured within the meal tolerance test (MTT) performed on day 5 post-intervention. Timepoints at 0,30,60,90,120,150, 180 and 360 min after consuming the standardized breakfast.

Secondary outcome [4]

Postprandial lipemia (composite outcome) will be assessed by determining serum cholesterol, triglycerides, and HDL-cholesterol concentrations during the meal tolerance test (MTT).

Timepoint [4]

Measured within the meal tolerance test (MTT) performed on day 5 post-intervention. Timepoints at 0,30,60,90,120,150, 180 and 360 min after consuming the standardized breakfast.

Secondary outcome [5]

Fasting glycemia and lipids (composite outcome). Serum glucose, insulin, triglycerides, cholesterol will be evaluated as changes from baseline.

Timepoint [5]

Changes in fasting parameters will be evaluated as changes between serum values obtained on day 5 and day 1 of the experimental period.

Eligibility

Key inclusion criteria

1. Subjects with type 2 diabetes (T2D) previously diagnosed according to the American Diabetes Association.
2. Aged 25-60. Both males and females.
3. Body Mass Index (BMI) > 25 kg/m2.
4. Type 2 diabetic with glycosylated hemoglobin (HbA1c) over 6.5%, Under treatment with oral medication such as glibenclamide and/or metformin or lifestyle control.

Minimum age

25 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Smoking or alcohol intake.
2. Presence of cardiovascular, renal, hepatic or gastrointestinal disease (Crohn´s disease, colitis, gastroenteritis, celiac disease, short bowel syndrome).
3. Use of any medication with insulin, glitazones, DPP4 inhibitors, GLP -1 analogues, or other drugs that alter the absorption of monosaccharides, such as acarbose.
4. Have some form of psychiatric treatment.
5. Pregnant or breast-feeding females.
6. Practice physical exercise for more than 4 h a week.
7. Have non-permeable veins.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

8/02/2016

Date of last participant enrolment

Anticipated

Actual

24/04/2017

Date of last data collection

Anticipated

Actual

30/05/2017

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Mexico

State/province [1]

Tabasco

Funding & Sponsors

Funding source category [1]

University

Name [1]

Universidad Juárez Autónoma de Tabasco

Address [1]

Av. Universidad S/N
Zona de la Cultura
Colonia Magisterial C.P. 86040
Villahermosa, Centro, Tabasco

Country [1]

Mexico

Primary sponsor type

University

Name

Universidad Juárez Autónoma de Tabasco

Address

Av. Universidad S/N
Zona de la Cultura
Colonia Magisterial C.P. 86040
Villahermosa, Centro, Tabasco

Country

Mexico

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Hospital General de Zona 46, Instituto Mexicano del Seguro Social

Address [1]

Carretera Villahermosa-Frontera S/N
Colonia casa Blanca C.P. 86090
Villahermosa, Tabasco

Country [1]

Mexico

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comité Local de Investigación y Etica en la Investigación en Salud No. 2701

Ethics committee address [1]

Hospital General de Zona No. 2
Francisco Trujillo Gurria S/N
Colonia Pueblo Nuevo C.P. 86500
Cardenas Tabasco

Ethics committee country [1]

Mexico

Date submitted for ethics approval [1]

Approval date [1]

03/11/2015

Ethics approval number [1]

2015-2701-17

Summary

Brief summary

The prevalence of type 2 diabetes (T2D) is increasing globally, and Mexico is at the forefront of this disease. Uncontrolled T2D is associated with long-term microvascular complications, such as nephropathy, neuropathy, retinopathy, or cardiovascular disease. Thus, strict glucose management is required for these patients. Among the strategies to achieve this goal is the adoption of modifications in lifestyle. In this line, resistant starch (RS) supplementation has been shown to decrease the glycemic response. However, the effects of RS on glycemic variability (GV), postprandial lipemia, or appetite are not well understood. We will conduct a randomized, crossover study to determine the effects of RS from two sources on GV, postprandial lipids, and appetite sensations in subjects with T2D. We will analyze the GV using the continuous glucose monitoring system (CGMS) during the intervention phase. During this period, we will perform a meal tolerance test (MTT) to analyze glycemic and insulinemic responses, as well as, appetite sensations. We hypothesized that RS supplementation could reduce GV, glycemic response, postprandial lipemia and have a positive influence on subjective appetite scores.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jorge Luis Ble Castillo

Address

Centro de Investigación
División Académica de Ciencias de la Salud
Universidad Juárez Autónoma de Tabasco
Avenida Gregorio Méndez 2838-A
Colonia Tamulté
Villahermosa, Tabasco, México
C.P. 86150

Country

Mexico

Phone

+52 1 993 173 5353

Fax

jblecastillo@hotmail.com

Contact person for public queries

Name

Jorge Luis Ble Castillo

Address

Country

Mexico

Phone

+52 1 993 173 5353

Fax

jblecastillo@hotmail.com

Contact person for scientific queries

Name

Jorge Luis Ble Castillo

Address

Country

Mexico

Phone

+52 1 993 173 5353

Fax

jblecastillo@hotmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
11844	Ethical approval					367316-(Uploaded-31-05-2021-05-22-42)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Resistant starch consumption effects on glycemic control and glycemic variability in patients with type 2 diabetes: A randomized crossover study.	2021	https://dx.doi.org/10.3390/nu13114052
Embase	Effects of resistant starch on glycemic response, postprandial lipemia and appetite in subjects with type 2 diabetes.	2023	https://dx.doi.org/10.1007/s00394-023-03154-4

N.B. These documents automatically identified may not have been verified by the study sponsor.

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