The Effect of Mankai on Glycemic Control Among Patients With T2D

NCT06416475 | Active Not Recruiting Phase 2

• 1 other identifier: SOR-0259-23
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to explore the effect of daily supplementation of Wolfia globosa Mankai on HbA1c and insulin resistance response among participants with type 2 diabetes (T2D). The investigators hypothesize that adding daily Mankai to T2D's healthy nutrition might lower HbA1c and promote glycemic control. Methods: A 3-month pilot RCT among 104 patients with T2D, with two intervention arms consuming comparable bottle volumes of either crude plant Mankai beverage (60ml Mankai) or water (60ml) 3 times/day postprandially over 3 months. Blood, urine, fecal, and clinical measures will be taken at 0 and 3 months. Overall appetite, food intake, symptoms, and medical treatment will be monitored. Importance: This study's results will shed light on the effects of regular Mankai consumption on HbA1c among patients with T2D, which may reveal a new nutritional source to improve glycemic control in T2D.

Conditions

Diabetes Mellitus, Type 2

Keywords

clinical trial; Diabetes Mellitus, Type 2; nutritional intervention; Mankai Duckweed; Wolffia-globosa; polyphenols

Outcome Measures

Primary Outcomes (2)

• HbA1c

  Glycated hemoglobin-HbA1c; as detected by a standard laboratory measure

  Baseline and three months time points

• Fasting glycemic and insulin resistance profiling

  Fasting glycemic and insulin resistance profiling \[using calculated homeostatic model assessment of insulin resistance (HOMA-IR) as detected by laboratory assessment\]

  Baseline and three months time points

Secondary Outcomes (30)

• Lipid profile

  Baseline and three months time points

• Lipid profile

  Baseline and three months time points

• Hormones and adipokines

  Baseline and three months time points

• Inflammatory biomarkers

  Baseline and three months time points

• Hunger/satiety hormones

  Baseline and three months time points

Study Arms (2)

Mankai supplementation group

ACTIVE COMPARATOR

Three times a day supplementation of postprandial Mankai duckweed drink (60mL crude plant Mankai beverage) right after breakfast, lunch, and dinner while maintaining the recommended Mediterranean diet lifestyle and medical treatment.

Dietary Supplement: Mankai supplementation

Water group

PLACEBO COMPARATOR

Three times a day consumption of postprandial water (60mL) right after breakfast, lunch, and dinner while maintaining the recommended Mediterranean diet lifestyle and medical treatment.

Other: Water consumption

Interventions

Mankai supplementation DIETARY_SUPPLEMENT

The overall dose of the three Mankai duckweed beverages/day contains \~10 grams of dry matter.

Mankai supplementation group

Water consumption OTHER

Water consumption

Water group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 30 years
• A formal diagnosis of T2D (126mg/dl fasting glucose or higher, or HbA1c\>6.5%) or taking T2D medications with HbA1c levels over 7%
• Medication stability for at least 3 months prior to Intervention initiation
• Adherence to medical follow-up in primary care clinic or diabetes-centered outpatient services

You may not qualify if:

• HbA1c lower than 7% or higher than 10%
• Known insulinopenia
• Treatment with coumadin (warfarin)
• Advanced renal failure
• Significantly disturbed liver enzymes (liver transaminases or bilirubin levels more than time three upper-normal-limit)
• A significant illness that might require hospitalization
• Regular Mankai consumption
• State of pregnancy or lactation
• Presence of active cancer or chemotherapy treatment in last three years
• Participation in another trial

Sponsors & Collaborators

• Ben-Gurion University of the Negev: lead
• Soroka University Medical Center: collaborator

Study Sites (1)

Soroka Medical Center

Beersheba, Israel

Location

Related Publications (19)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Drinking

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Eating; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Idit Liberty

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

• Iris Shai

  Ben-Gurion University of the Negev

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Iris Shai

Model Details: A 3-month Randomized Controlled pilot Trial among 104 patients with T2D, who will be randomly allocated to consume comparable bottle volumes of either crude plant Mankai beverage (60ml Mankai) or water (60ml) on top of a standardized MediterraneanT2D-recommended healthy diet, after morning, lunch, and dinner over 3 months.

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: May 16, 2024
• Study Start: April 30, 2024
• Primary Completion: August 8, 2024
• Study Completion: August 15, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)