Clinical trial NCT05272839: Association Between Natural Hypoglycemic Foods and Blood Sugar Level: A Pilot Study
Official title: Association Between Natural Hypoglycemic Foods and Blood Sugar Level: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type II Diabetes
Lead sponsor: Antenna Foundation
Sponsor class: OTHER
Collaborators: name: Khon Kaen University
First posted: 2022-03-10
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At the first visit, patients will be randomly assigned to control group or intervention group.
Primary purpose: TREATMENT

Brief summary: Type 2 diabetes patients often do not reach desired control of glycemia despite guidance on changing lifestyle and diet as well as the use of conventional anti-diabetic medication. Parallely in recent years, an array of comparative clinical studies have demonstrated the anti-diabetic effect of more than 10 common spices and food products. Objectives: to evaluate whether proposing a choice of spices and foods products with hypoglycemic effect to diabetic patients can help better control diabetes.

Detailed description: Diabetic type II patients would be encouraged to eat what they like within a list of food products with hypoglycemic effect, at a similar dosage and preparation mode than the one in the reference clinical trials.

This pilot project will be conducted as a randomized controlled trial with 2 arms over 12 weeks: 1. training patients about hypoglycemic spices and foods alongside their usual anti-diabetic treatment, versus usual anti-diabetic treatment alone.

Expected results: Confirmation of the hypothesis that daily consuming spices and foods with hypoglycemic effect to diabetic patients can help better control diabetes.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes patients with poorly controlled glycemia, i.e. at least one of the following measurements:

  1. Fasting plasma glucose (FPG) values ≥ 7.0 mmol/L (126 mg/dl), or 2-h post-load plasma glucose ≥ 11.1 mmol/L (200 mg/dl), or HbA1c \> 6.5% (48 mmol/mol); or a random blood glucose ≥ 11.1 mmol/L (200 mg/ dl), despite ≥ 3 months usual care (lifestyle + medication if applicable).

Exclusion criteria:

1. Severe and unstable complications of diabetes: end-organ damage such as nephropathy, retinopathy, neuropathy, etc...
2. Patients with rapid insulin,
3. Any health condition that requires urgent attention,
4. Patients with a cognitive or sensory impairment that may prevent conducting the interview,
5. HbA1c \> 11.5%
6. Pregnant women

Primary outcomes:
measure: Decrease of ≥ 0.5mmol/L in FPG
timeFrame: 12 weeks
measure: Decrease of ≥ 0.5 points of percentage of HbA1c
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean change of FPG
timeFrame: 12 weeks
measure: Target glycemia
timeFrame: 12 weeks
measure: Weight
timeFrame: 12 weeks
measure: Mean change of HbA1c
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Antenna Foundation
name: Bertrand Graz, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Willcox ML, Elugbaju C, Al-Anbaki M, Lown M, Graz B. Effectiveness of Medicinal Plants for Glycaemic Control in Type 2 Diabetes: An Overview of Meta-Analyses of Clinical Trials. Front Pharmacol. 2021 Nov 26;12:777561. doi: 10.3389/fphar.2021.777561. eCollection 2021.