Trial Review

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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
Date results information 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] 285549 0
None
Universal Trial Number (UTN)
U1111-1163-4254
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 293367 0
Condition category
Condition code
Metabolic and Endocrine 293649 293649 0 0
Diabetes
Diet and Nutrition 293650 293650 0 0
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] 290499 0
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] 293469 0
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] 293469 0
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] 311115 0
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] 311115 0
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] 311116 0
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] 311116 0
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] 311117 0
Subjective Appetite Assessment using a Visual Analogue Scale (VAS).
Timepoint [3] 311117 0
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] 396208 0
Postprandial lipemia (composite outcome) will be assessed by determining serum cholesterol, triglycerides, and HDL-cholesterol concentrations during the meal tolerance test (MTT).
Timepoint [4] 396208 0
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] 401553 0
Fasting glycemia and lipids (composite outcome). Serum glucose, insulin, triglycerides, cholesterol will be evaluated as changes from baseline.
Timepoint [5] 401553 0
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?
No
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
17
Accrual to date
Final
17
Recruitment outside Australia
Country [1] 23725 0
Mexico
State/province [1] 23725 0
Tabasco

Funding & Sponsors
Funding source category [1] 308694 0
University
Name [1] 308694 0
Universidad Juárez Autónoma de Tabasco
Country [1] 308694 0
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] 309577 0
None
Name [1] 309577 0
Address [1] 309577 0
Country [1] 309577 0
Other collaborator category [1] 281809 0
Hospital
Name [1] 281809 0
Hospital General de Zona 46, Instituto Mexicano del Seguro Social
Address [1] 281809 0
Carretera Villahermosa-Frontera S/N
Colonia casa Blanca C.P. 86090
Villahermosa, Tabasco
Country [1] 281809 0
Mexico

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308617 0
Comité Local de Investigación y Etica en la Investigación en Salud No. 2701
Ethics committee address [1] 308617 0
Hospital General de Zona No. 2
Francisco Trujillo Gurria S/N
Colonia Pueblo Nuevo C.P. 86500
Cardenas Tabasco
Ethics committee country [1] 308617 0
Mexico
Date submitted for ethics approval [1] 308617 0
Approval date [1] 308617 0
03/11/2015
Ethics approval number [1] 308617 0
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 52322 0
Dr Jorge Luis Ble Castillo
Address 52322 0
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 52322 0
Mexico
Phone 52322 0
+52 1 993 173 5353
Fax 52322 0
Email 52322 0
[email protected]
Contact person for public queries
Name 52323 0
Dr Jorge Luis Ble Castillo
Address 52323 0
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 52323 0
Mexico
Phone 52323 0
+52 1 993 173 5353
Fax 52323 0
Email 52323 0
[email protected]
Contact person for scientific queries
Name 52324 0
Dr Jorge Luis Ble Castillo
Address 52324 0
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 52324 0
Mexico
Phone 52324 0
+52 1 993 173 5353
Fax 52324 0
Email 52324 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11844Ethical 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
SourceTitleYear of PublicationDOI
EmbaseEffects of resistant starch on glycemic response, postprandial lipemia and appetite in subjects with type 2 diabetes.2023https://dx.doi.org/10.1007/s00394-023-03154-4
EmbaseResistant starch consumption effects on glycemic control and glycemic variability in patients with type 2 diabetes: A randomized crossover study.2021https://dx.doi.org/10.3390/nu13114052
N.B. These documents automatically identified may not have been verified by the study sponsor.