A Randomized Clinical Trial of a Standardized Pumpkin-Seed-Derived Peptide Extract: Body Composition Outcomes and Exploratory Analysis by Baseline Adiposity in Overweight Adults
- 1Graduate Institute of Food Science and Technology, National Taiwan University, Taipei 10617, Taiwan
- 2Research and Development Department, Greenyn Biotechnology Co., Ltd., Taichung City 40768, Taiwan
- 3Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical University, Taipei 11696, Taiwan
Abstract
This 12-week, randomized, double-blind, placebo-controlled trial enrolled 50 overweight adults who received either a standardized pumpkin-seed-derived preparation (IRK-19®, 600 mg/day) or placebo. The clinical preparation contained 66.2% crude protein; components with apparent molecular weights ≤6.29 kDa accounted for 23.6% of the total SEC-UV chromatographic area, and the combined HPLC-measured content of six selected peptide markers was 2.79% (w/w). Among the 48 participants with evaluable DXA data at Week 12, between-group comparisons of body weight, BMI, and adiposity-related outcomes did not reach statistical significance in the overall study population. In a post hoc exploratory subgroup defined by baseline total fat mass ≥28.4 kg (the study-specific 75th percentile; n = 13), adjusted between-group differences (IRK-19® minus placebo) at Week 12 were −2.30 kg for body weight (95% CI, −4.08 to −0.51; p = 0.018), −0.75 kg/m2 for BMI (95% CI, −1.48 to −0.02; p = 0.045), and −1.60 kg for total fat mass (95% CI, −3.23 to 0.04; p = 0.055). Treatment-by-baseline-fat-mass interactions did not reach statistical significance for body weight, BMI, or total fat mass (p = 0.065, 0.106, and 0.057, respectively). These post hoc subgroup findings warrant further investigation but were not adjusted for multiple comparisons. Prospectively designed trials with prespecified adiposity strata are needed to determine whether baseline fat mass is associated with differential treatment response. Individual metabolic laboratory abnormalities also warrant further assessment in future prospective trials.
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BibTeX
@article{lin2026randomized,
title = {{A Randomized Clinical Trial of a Standardized Pumpkin-Seed-Derived Peptide Extract: Body Composition Outcomes and Exploratory Analysis by Baseline Adiposity in Overweight Adults}},
author = {Yu-Cheng Lin and Wan-Yu Chung and Yen-Nung Lin and Pang-Kuei Hsu},
journal = {International journal of molecular sciences},
year = {2026},
month = oct,
doi = {10.3390/ijms27198813},
url = {https://europepmc.org/article/PMC/PMC13665551},
note = {CC BY},
}
RIS
TY - JOUR
TI - A Randomized Clinical Trial of a Standardized Pumpkin-Seed-Derived Peptide Extract: Body Composition Outcomes and Exploratory Analysis by Baseline Adiposity in Overweight Adults
AU - Yu-Cheng Lin
AU - Wan-Yu Chung
AU - Yen-Nung Lin
AU - Pang-Kuei Hsu
PY - 2026
DA - 2026/10/01
JO - International journal of molecular sciences
DO - 10.3390/ijms27198813
UR - https://europepmc.org/article/PMC/PMC13665551
AB - This 12-week, randomized, double-blind, placebo-controlled trial enrolled 50 overweight adults who received either a standardized pumpkin-seed-derived preparation (IRK-19®, 600 mg/day) or placebo. The clinical preparation contained 66.2% crude protein; components with apparent molecular weights ≤6.29 kDa accounted for 23.6% of the total SEC-UV chromatographic area, and the combined HPLC-measured content of six selected peptide markers was 2.79% (w/w). Among the 48 participants with evaluable DXA data at Week 12, between-group comparisons of body weight, BMI, and adiposity-related outcomes did not reach statistical significance in the overall study population. In a post hoc exploratory subgroup defined by baseline total fat mass ≥28.4 kg (the study-specific 75th percentile; n = 13), adjusted between-group differences (IRK-19® minus placebo) at Week 12 were −2.30 kg for body weight (95% CI, −4.08 to −0.51; p = 0.018), −0.75 kg/m2 for BMI (95% CI, −1.48 to −0.02; p = 0.045), and −1.60 kg for total fat mass (95% CI, −3.23 to 0.04; p = 0.055). Treatment-by-baseline-fat-mass interactions did not reach statistical significance for body weight, BMI, or total fat mass (p = 0.065, 0.106, and 0.057, respectively). These post hoc subgroup findings warrant further investigation but were not adjusted for multiple comparisons. Prospectively designed trials with prespecified adiposity strata are needed to determine whether baseline fat mass is associated with differential treatment response. Individual metabolic laboratory abnormalities also warrant further assessment in future prospective trials.
SN - 1422-0067
ER -