NCT05727592

Brief Summary

The purpose of this study is to determine whether Brazilian spinach supplementation effective in improving the nutritional status of Type 2 Diabetes Mellitus patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

December 29, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

December 29, 2022

Last Update Submit

November 29, 2023

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Glycaemic control (HbA1c level)

    The outcome to be measured are the hbA1c level in which it will be measured in percentage.

    3 months

  • Fasting blood glucose

    The outcome to be measured are the fasting blood glucose (FBS) in which it will be measured in mmol/L.

    3 months

Secondary Outcomes (5)

  • Anthropometric measurements

    3 months

  • Blood pressure

    3 months

  • Dietary Intake

    3 months

  • Liver profile

    3 months

  • Renal profile

    3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intervention: Diabetic Brazilian spinach supplementation group Subjects in this group will be receiving Brazilian spinach for 12 weeks in which they must consume 15g of Brazilian spinach daily with lunch or dinner.

Dietary Supplement: Althernanthera Sissoo

Control Group

EXPERIMENTAL

No intervention: Diabetic control group Subjects in this group will not receive Brazilian spinach. However, they will be receiving standard dietary counselling and educated for the same lifestyle intervention as in the intervention group.

Behavioral: Dietary Consultation

Interventions

Althernanthera SissooDIETARY_SUPPLEMENT

15g of Althernanthera Sissoo consumed with lunch or dinner per day.

Also known as: Brazilian Spinach
Intervention Group
Dietary ConsultationBEHAVIORAL

Dietary consultation to improve the intakes of vegetables daily

Control Group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 30-65 years old
  • Have confirmed diagnosed with type 2 diabetes mellitus of equal or more than 6 months
  • HbA1c levels equal or more than 7% (within the last 3 months of recruitment)
  • On at least one oral hypoglycemic agent
  • Agree not to take other herbal or nutritional supplements for the duration of study.

You may not qualify if:

  • Unable to tolerate to fiber especially vegetables
  • Type 1 diabetes mellitus
  • Pregnant
  • Insulin treatment
  • Severe diabetic complications including end-stage renal diseases, liver diseases or gastrointestinal diseases
  • On coagulant therapy (warfarin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Interventional study: parallel, single and non-blinded study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 29, 2022

First Posted

February 14, 2023

Study Start

March 20, 2023

Primary Completion

June 17, 2023

Study Completion

September 5, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)