Nutritional, Metabolic, Endocrine
Conditions
Interventions
Placebo
Okra Arm
Sponsors
Imo State University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 30–70 years (adults, inclusive of both sexes). Confirmed diagnosis of type 2 diabetes mellitus (T2D) according to ADA criteria =6 months prior to screening. HbA1c 7.0–9.5% at screening (moderate, suboptimally controlled). On stable metformin monotherapy (=1,000 mg/day) for at least 8–12 weeks prior to screening. Body mass index (BMI) 25–40 kg/m². Willing and able to maintain stable background diet, physical activity, and medications during the 24-week intervention. No current use of GLP-1 receptor agonists, DPP-4 inhibitors, or SGLT2 inhibitors, and willing to avoid initiation during the trial. Able to give informed consent and comply with all study visits, procedures, and investigational product intake. Access to a reliable method of weekly study product pick-up/delivery. Women of childbearing potential must agree to use reliable contraception throughout the study period.
Exclusion criteria
Exclusion criteria: Type 1 diabetes, history of diabetic ketoacidosis, or secondary forms of diabetes. Current or recent (<3 months) use of incretin-based therapies (GLP-1 receptor agonists, DPP-4 inhibitors) or SGLT2 inhibitors. Use of insulin therapy (basal, prandial, or mixed) within the past 6 months. Significant gastrointestinal disorders that could interfere with absorption or tolerability, including: Inflammatory bowel disease, celiac disease, chronic diarrhea, or short bowel syndrome Prior GI surgery causing malabsorption or altered motility (e.g., bariatric surgery, gastrectomy) Known kidney stone disease (nephrolithiasis) or history of recurrent oxalate nephropathy. Moderate-to-severe renal impairment (eGFR <45 mL/min/1.73 m²) or significant hepatic impairment (Child–Pugh B or C). Clinically significant cardiovascular event (MI, stroke, coronary revascularization, hospitalization for heart failure) within 6 months prior to screening. Current use of bile acid sequestrants (e.g., cholestyramine, colesevelam) or other oral agents known to interfere with nutrient/fiber absorption. Known allergy or intolerance to okra, cellulose-based products, or components of the investigational product/placebo. Pregnant or breastfeeding women, or women planning pregnancy during the study period. Uncontrolled hypertension (SBP =160 mmHg or DBP =100 mmHg) despite stable therapy. Active malignancy (excluding non-melanoma skin cancers) within the past 5 years. Significant psychiatric illness, cognitive impairment, or substance abuse that could limit adherence or informed consent. Participation in another interventional clinical trial within the past 3 months. Any other condition that, in the judgment of the investigator, would pose undue risk or interfere with study outcomes (e.g., unstable thyroid disease, severe anemia, recent major surgery).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome 1 Title: Change in active GLP-1 incremental area under the curve (iAUC0–120??????) during a standardized mixed-meal tolerance test. Description: Active GLP-1 concentrations (pmol/L) will be measured at baseline, midpoint, and endpoint Week 24 during a 120-minute mixed-meal tolerance test with samples collected at 0, 15, 30, 45, 60, 90, and 120 minutes. The incremental area under the concentration–time curve (iAUC0–120, pmol·min/L) will be calculated using the trapezoidal method. The outcome is defined as the change in iAUC (pmol·min/L) from baseline to Week 24. A positive change indicates increased GLP-1 secretion. Unit of Measure: pmol·min/L. Primary Outcome 2 Title: Change in glycated hemoglobin (HbA1c). Description: HbA1c (%) will be measured at baseline, midpoint, and endp point week 24 using an NGSP-certified assay. The outcome is defined as the absolute change in HbA1c percentage points (e.g., from 8.0% to 7.5% = –0.5%) from baseline to Week 24. A negative change indicates improved glycemic control. Unit of Measure: % (percentage points). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in active GIP incremental area under the curve (iAUC0–120min) during a mixed-meal tolerance test. Active GIP (pmol/L) measured at 0–120 minutes during a standardized MMT at each study visit; iAUC (pmol·min/L) calculated by trapezoidal method. Change in plasma DPP-4 enzymatic activity. Fasting plasma DPP-4 activity quantified using a validated fluorometric assay. Change in post-prandial glucose iAUC0–120?during MMT. Plasma glucose (mmol/L) measured at 0–120 minutes during MMT; iAUC computed by trapezoidal method. Continuous glucose monitoring (CGM): mean glucose and % time in range. CGM metrics include mean glucose (mmol/L), % time in range 3.9–10.0 mmol/L, % time 10.0 mmol/L, and glycemic variability (coefficient of variation). Change in fasting plasma glucose and insulin; insulin resistance index. Fasting glucose (mmol/L) and insulin (pmol/L) measured at each visit; HOMA-IR calculated. Oral ß-cell function (disposition index) from MMT. Insulin secretion indices (insulinogenic index, oral disposition index) derived from glucose and insulin/C-peptide during MMT. Gastric emptying proxy during MMT. Acetaminophen absorption test (1.5 g co-ingested with MMT). Outcomes: acetaminophen Serum lipid profile. Fasting total cholesterol, LDL-C, HDL-C, triglycerides measured by central laboratory. Body weight and BMI. Body weight measured fasting with light clothing; BMI calculated from weight and height. Waist circumference and blood pressure. Waist measured at iliac crest–rib midpoint; seated systolic and diastolic blood pressure measured using standardized protocol. Fasting plasma bile acids (total and selected species). Quantified by LC-MS/MS; includes primary and secondary bile acids. Stool microbiome composition and short-chain fatty acids (optional substudy). Microbiome assessed by 16S rRNA or metagenomics (diversity, relativeelative abundance); stool SCFAs (acetate, propionate, butyrate) quantified. | — |
Countries
Nigeria
Contacts
Public ContactEmmanuel Agomuo
Professor
Outcome results
None listed