---
title: "Sodium pentaborate pentahydrate for overweight and obesity: phase 1/2 randomized trial"
id: "pubmed-42634930"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42634930"
content_type: "clinical_feed_article"
specialty: "Endocrinology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42634930/"
doi: "10.1080/21623945.2026.2716431"
published_at: "2026-08-24T12:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Sodium pentaborate pentahydrate for overweight and obesity: phase 1/2 randomized trial
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42634930
- **Specialty:** [Endocrinology](https://medichelpline.com/clinical-feed/endocrinology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42634930/)
- **DOI:** [10.1080/21623945.2026.2716431](https://doi.org/10.1080%2F21623945.2026.2716431)
- **Published At:** 2026-08-24T12:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This randomized, double‑blind, placebo‑controlled phase 1/2 trial evaluated short‑term safety, tolerability, and preliminary efficacy of **sodium pentaborate pentahydrate (NaB)** in adults with **overweight** or **obesity**. - The trial enrolled 177 adults between July 2024 and January 2025; 116 participants completed the 12‑week intervention. - Participants were randomized to placebo or NaB at doses of **200, 400, 600, 800, or 1,000 mg** daily for 12 weeks, alongside a standardized diet and exercise programme. - The primary safety assessment included adverse events, hypoglycaemic episodes, gastrointestinal adverse events, and routine haematological and biochemical laboratory parameters. - No major short‑term safety signal was observed; all reported adverse events were mild, and no clinically meaningful changes in renal, hepatic, or haematological markers were reported. - The primary exploratory efficacy endpoint was percentage change in **body weight** from baseline to week 12; secondary/exploratory outcomes included BMI, waist and hip circumferences, waist‑to‑hip ratio, glycaemic markers, lipid parameters, and blood pressure. - Mean body weight decreased in several active‑dose groups: **400 mg (−2.6 kg)**, **600 mg (−1.2 kg)**, and **1,000 mg (−3.1 kg)** over 12 weeks. - Compared with placebo, the **1,000 mg** dose produced the largest reductions in body weight (mean difference −2.30 kg; p = 0.01) and **BMI** (mean difference −0.85 kg/m2; p = 0.02). - The authors conclude that the **1,000 mg** dose demonstrated preliminary efficacy for reducing body weight and BMI over 12 weeks, with no major short‑term safety concerns. - The findings are exploratory and the authors state that confirmation in larger phase 3 trials with longer follow‑up is required to evaluate long‑term safety and efficacy.
## Clinical Analysis & Structured Key Points
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Epub 2026 Aug 24. # Assessment of the safety and efficacy of sodium pentaborate pentahydrate in individuals with overweight and obesity: a randomized, double-blind, placebo-controlled, phase 1/2 dose-finding trial [Fikrettin Şahin](https://pubmed.ncbi.nlm.nih.gov/?term=%C5%9Eahin+F&cauthor_id=42634930)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#full-view-affiliation-1 "Department of Genetics and Bioengineering, Yeditepe University, Istanbul, Turkey."), [Nahid Karamzad](https://pubmed.ncbi.nlm.nih.gov/?term=Karamzad+N&cauthor_id=42634930)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#full-view-affiliation-2 "Social Determinants of Health Research Center, Department of Community Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.")[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#full-view-affiliation-3 "Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran."), [Reza Aletaha](https://pubmed.ncbi.nlm.nih.gov/?term=Aletaha+R&cauthor_id=42634930)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#full-view-affiliation-2 "Social Determinants of Health Research Center, Department of Community Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran."), [Fateme Tahmasbi](https://pubmed.ncbi.nlm.nih.gov/?term=Tahmasbi+F&cauthor_id=42634930)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#full-view-affiliation-2 "Social Determinants of Health Research Center, Department of Community Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran."), [Fatemeh Amiri](https://pubmed.ncbi.nlm.nih.gov/?term=Amiri+F&cauthor_id=42634930)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#full-view-affiliation-2 "Social Determinants of Health Research Center, Department of Community Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran."), [Mark J M Sullman](https://pubmed.ncbi.nlm.nih.gov/?term=Sullman+MJM&cauthor_id=42634930)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#full-view-affiliation-4 "Department of Life and Health Sciences, University of Nicosia, Nicosia, Cyprus.")[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#full-view-affiliation-5 "Department of Social Sciences, University of Nicosia, Nicosia, Cyprus."), [Jessica A Grieger](https://pubmed.ncbi.nlm.nih.gov/?term=Grieger+JA&cauthor_id=42634930)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#full-view-affiliation-6 "Adelaide Medical School and the Robinson Research Institute, Adelaide University, Adelaide, South Australia, Australia."), [Saeid Safiri](https://pubmed.ncbi.nlm.nih.gov/?term=Safiri+S&cauthor_id=42634930)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#full-view-affiliation-1 "Department of Genetics and Bioengineering, Yeditepe University, Istanbul, Turkey.")[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#full-view-affiliation-7 "Research Center for Integrative Medicine in Aging, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.") Affiliations Expand ### Affiliations * 1 Department of Genetics and Bioengineering, Yeditepe University, Istanbul, Turkey. * 2 Social Determinants of Health Research Center, Department of Community Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. * 3 Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. * 4 Department of Life and Health Sciences, University of Nicosia, Nicosia, Cyprus. * 5 Department of Social Sciences, University of Nicosia, Nicosia, Cyprus. * 6 Adelaide Medical School and the Robinson Research Institute, Adelaide University, Adelaide, South Australia, Australia. * 7 Research Center for Integrative Medicine in Aging, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran. * PMID: **42634930** * DOI: [ 10.1080/21623945.2026.2716431 ](https://doi.org/10.1080/21623945.2026.2716431) Item in Clipboard Clinical Trial # Assessment of the safety and efficacy of sodium pentaborate pentahydrate in individuals with overweight and obesity: a randomized, double-blind, placebo-controlled, phase 1/2 dose-finding trial Fikrettin Şahin et al. Adipocyte. 2026 Dec. Show details Display options Display options Format Abstract PubMed PMID Adipocyte Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Adipocyte%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Adipocyte%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42634930/) . 2026 Dec;15(1):2716431. doi: 10.1080/21623945.2026.2716431. Epub 2026 Aug 24. ### Authors [Fikrettin Şahin](https://pubmed.ncbi.nlm.nih.gov/?term=%C5%9Eahin+F&cauthor_id=42634930)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#short-view-affiliation-1 "Department of Genetics and Bioengineering, Yeditepe University, Istanbul, Turkey."), [Nahid Karamzad](https://pubmed.ncbi.nlm.nih.gov/?term=Karamzad+N&cauthor_id=42634930)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#short-view-affiliation-2 "Social Determinants of Health Research Center, Department of Community Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.")[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#short-view-affiliation-3 "Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran."), [Reza Aletaha](https://pubmed.ncbi.nlm.nih.gov/?term=Aletaha+R&cauthor_id=42634930)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#short-view-affiliation-2 "Social Determinants of Health Research Center, Department of Community Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran."), [Fateme Tahmasbi](https://pubmed.ncbi.nlm.nih.gov/?term=Tahmasbi+F&cauthor_id=42634930)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#short-view-affiliation-2 "Social Determinants of Health Research Center, Department of Community Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran."), [Fatemeh Amiri](https://pubmed.ncbi.nlm.nih.gov/?term=Amiri+F&cauthor_id=42634930)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#short-view-affiliation-2 "Social Determinants of Health Research Center, Department of Community Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran."), [Mark J M Sullman](https://pubmed.ncbi.nlm.nih.gov/?term=Sullman+MJM&cauthor_id=42634930)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#short-view-affiliation-4 "Department of Life and Health Sciences, University of Nicosia, Nicosia, Cyprus.")[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#short-view-affiliation-5 "Department of Social Sciences, University of Nicosia, Nicosia, Cyprus."), [Jessica A Grieger](https://pubmed.ncbi.nlm.nih.gov/?term=Grieger+JA&cauthor_id=42634930)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#short-view-affiliation-6 "Adelaide Medical School and the Robinson Research Institute, Adelaide University, Adelaide, South Australia, Australia."), [Saeid Safiri](https://pubmed.ncbi.nlm.nih.gov/?term=Safiri+S&cauthor_id=42634930)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#short-view-affiliation-1 "Department of Genetics and Bioengineering, Yeditepe University, Istanbul, Turkey.")[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42634930/#short-view-affiliation-7 "Research Center for Integrative Medicine in Aging, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.") ### Affiliations * 1 Department of Genetics and Bioengineering, Yeditepe University, Istanbul, Turkey. * 2 Social Determinants of Health Research Center, Department of Community Medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. * 3 Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. * 4 Department of Life and Health Sciences, University of Nicosia, Nicosia, Cyprus. * 5 Department of Social Sciences, University of Nicosia, Nicosia, Cyprus. * 6 Adelaide Medical School and the Robinson Research Institute, Adelaide University, Adelaide, South Australia, Australia. * 7 Research Center for Integrative Medicine in Aging, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran. * PMID: **42634930** * DOI: [ 10.1080/21623945.2026.2716431 ](https://doi.org/10.1080/21623945.2026.2716431) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## Abstract The present study aimed to examine the short-term safety and tolerability of sodium pentaborate pentahydrate (NaB) and to explore preliminary efficacy and dose selection as secondary objectives in individuals with overweight or obesity. In this randomized, double-blind, placebo-controlled, phase 1/2 trial, conducted from July 2024 to January 2025, 177 adults with overweight or obesity were randomized, of whom 116 completed the 12-week trial. Participants received placebo or NaB at doses of 200, 400, 600, 800, or 1,000 mg for 12 weeks, alongside a standardized diet and exercise programme. The primary safety objective was to investigate short-term safety and tolerability through adverse events, hypoglycaemic episodes, gastrointestinal adverse events, and changes in haematological and biochemical parameters. The primary exploratory efficacy outcome was percentage change in body weight from baseline to week 12. Secondary and exploratory efficacy outcomes included body weight, body mass index (BMI), waist and hip circumferences, waist-to-hip ratio, glycaemic markers, lipid parameters, and blood pressure. Baseline characteristics were broadly similar across groups (all p ≥ 0.05), and no major short-term safety signal was observed. Mean body weight decreased in the 400 mg (-2.6 kg), 600 mg (-1.2 kg), and 1,000 mg groups (-3.1 kg). Compared with placebo, the 1,000 mg dose resulted in the largest reductions in body weight (mean difference, -2.30 kg; p = 0.01) and BMI (mean difference, -0.85 kg/m2; p = 0.02). The 1,000 mg dose showed preliminary efficacy for reducing body weight and BMI over 12 weeks compared with placebo, with no major short-term safety signal and no clinically meaningful changes in renal, hepatic, or haematological markers. All reported adverse events were mild. These short-term findings are exploratory and require confirmation in future phase 3 trials with extended follow-up to investigate long-term safety and efficacy. **Keywords:** Anti-Obesity Agents; Body Mass Index; Body Weight; Borates; Boron Compounds; Clinical Trial; Drug Therapy; Obesity; Overweight; Safety. 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