(P15-014-23) A Short-term Dietary Supplement and Intermittent Fasting Regimen Improves Glycemic Control in Men and Women with Metabolic Risk Factors

Objectives: To determine the effect of a daily dietary supplement regimen with and without 16:8 intermittent fasting on glycemic control in free-living men and women.

Methods: Fifty adults (mean ± SD: age 52 ± 12 years, 74% female, BMI 30.0 ± 2.8 kg/m²) who met at least one of the following metabolic criteria were enrolled in this single-arm, single-blind study: elevated waist circumference ( > 102/88 cm for men/women), family history of impaired fasting glucose or type 2 diabetes, or sedentary lifestyle. A continuous glucose monitor (CGM) was applied to the back of the upper arm on Day 0. Following a baseline habitual diet phase (4-5 days), participants consumed assigned dietary supplements alone (Phase 1, 4 days) and then in combination with 16:8 intermittent fasting (Phase 2, 4 days). The supplements consisted of a yerba mate supplement (Unimate®) in the morning and a fiber supplement (Balance) taken prior to lunch and dinner. The primary outcome was the change in glycemic variability, measured by the glucose coefficient of variation (CV), from baseline to Phase 2. Secondary outcomes included the change in glucose CV from baseline to Phase 1, mean glucose, time in range, and number of hypoglycemic events. Trial registration: NCT05493553

Results: The glucose CV was lower during Phase 2 than baseline (-1.8%; 95% CI: -3.5 to -0.1%), with a corresponding increase in the time that glucose was in the ideal range (70-140 mg/dL) (median: 2.4%; p = 0.002). From baseline to Phase 1, the time in the ideal range also increased (median: 2.3%; p = 0.008), driven by a reduction in the time glucose values were < 70 mg/dL (median: -1.4%; p < 0.001). The dietary intervention was well tolerated with a low gastrointestinal symptom burden.

Conclusions: Given the prevalence of metabolic disorders globally, lifestyle interventions to improve glycemic control are especially important and relevant. Here, we demonstrated a short-term supplement regimen with 16:8 intermittent fasting can reduce glycemic variability and increase the time in an ideal glucose range in adults with metabolic risk factors.

Funding Sources: Unicity International, Inc.