Dihydroberberine Effects on Body Composition and Metabolic Health in Healthy Adults

Официальное название

Effects of Dihydroberberine Supplementation on Body Composition, Glycemic Control, Energy Levels, Appetite, and Mood in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial

Обзор

The goal of this clinical trial is to evaluate whether dihydroberberine (DHB) supplementation can improve body composition, blood sugar control, energy levels, appetite, and mood in healthy adults with overweight or mild obesity. The study focuses on men and women aged 35-55 years with a BMI between 27.0 and 33.0 kg/m². The main questions it aims to answer are: Does daily DHB supplementation lead to greater reductions in body weight over 12 weeks compared to placebo? Does DHB improve glycemic responses, appetite regulation, energy levels, and mood, both acutely (short-term) and chronically (over 12 weeks)? Researchers will compare two groups-one receiving DHB (400 mg/day) and the other receiving a placebo-administered as two capsules twice daily for 12 weeks. Participants will: Attend three in-clinic visits over approximately 14 weeks (including screening, baseline, and week 12 visits) Undergo mixed-meal tolerance tests (MTTs) to assess glucose metabolism, appetite, and energy levels Complete body composition assessments (including DXA scans), blood tests (e.g., glucose, insulin, HbA1c), and mood questionnaires (POMS-2) Be monitored for safety throughout the study

Вмешательства

• Пищевая добавка Placebo （Microcrystalline Cellulose）
  Participants will take 4 placebo capsules daily for 12 consecutive weeks, with 2 capsules taken in the morning and 2 in the evening. Each capsule contains 200 mg of microcrystalline cellulose, an inert substance used as an inactive control.
• Пищевая добавка Dihydroberberine（DHB）
  Participants will take 4 capsules daily (each containing 100 mg dihydroberberine \[DHB\] and 100 mg microcrystalline cellulose) orally for 12 consecutive weeks, with 2 capsules taken in the morning and 2 in the evening. The total daily dose of DHB is 400 mg.

Первичные конечные точки

• Body weight [Срок оценки: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)]

Вторичные конечные точки (12)

• Plasma Glucose Positive Incremental Area Under the Curve (piAUC) [Срок оценки: Baseline (Visit 2, Day 1): t=0 to t=120 minutes]
• Plasma Glucose Maximum Concentration (Cmax) [Срок оценки: Baseline (Visit 2, Day 1): t=0 to t=120 minutes]
• Plasma Glucose Time to Maximum Concentration (Tmax) [Срок оценки: Baseline (Visit 2, Day 1): t=0 to t=120 minutes]
• Composite Appetite Score Net Incremental Area Under the Curve (niAUC) [Срок оценки: Baseline (Visit 2, Day 1): t=0 to t=120 minutes]
• Net Incremental Area Under the Curve (niAUC0-120min) for Individual Appetite Visual Analog Scale (VAS) Ratings [Срок оценки: Baseline (Visit 2, Day 1): t=0 to t=120 minutes]
• Composite Appetite Score Positive Maximum Response [Срок оценки: Baseline (Visit 2, Day 1): t=0 to t=120 minutes]
• Individual Appetite Visual Analog Scale (VAS) Ratings Positive Maximum Response [Срок оценки: Baseline (Visit 2, Day 1): t=0 to t=120 minutes]
• Energy Composite Score Net Incremental Area Under the Curve (niAUC) [Срок оценки: Baseline (Visit 2, Day 1): t=0 to t=120 minutes]
• Energy Composite Score Positive Maximum Response [Срок оценки: Baseline (Visit 2, Day 1): t=0 to t=120 minutes]
• Fatigue Composite Score Net Incremental Area Under the Curve (niAUC) [Срок оценки: Baseline (Visit 2, Day 1): t=0 to t=120 minutes]
• Fatigue Composite Score Positive Maximum Response [Срок оценки: Baseline (Visit 2, Day 1): t=0 to t=120 minutes]
• Waist Circumference (WC) [Срок оценки: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)]

Критерии участия

Критерии включения

• 35 - 55 years of age (inclusive) at visit 1.
• BMI ≥ 27.0 - ≤ 33.0 kg/m2.
• Participant has a score of 7 - 10 on the Vein Access Scale Assessment at visit 1.
• Non-user or former user (daily use; cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1, and has no plans to begin use during the study period.
• Non-habitual users (i.e., daily or almost daily) of marijuana or hemp products, including CBD/THC products, and willing to abstain from use throughout the study period (topical creams/lotions are allowed).
• Willing to use personal smart phone with operating system capable of downloading and operating study applications (e.g., FitBit, smart scale, activity watch, etc).
• Willing to adhere to all study procedures, including lifestyle considerations (see section 6.3), and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.

Критерии исключения

• Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan/vegetarian) at the discretion of the Clinical Investigator.
• Individuals undergoing moderate-to-intense activity (e.g., sports/exercise ≥ 5h/wk).
• Recent weight changes (>4.5 kg ≤ 90 d of visit 1), or current/planned engagement in a weight change program (e.g., weight loss or muscle gain) outside of the researcher-instructed, self-directed Lifestyle Intervention throughout the study period.
• Abnormal laboratory test results of clinical significance at visit 1, at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to visit 2, for subjects with abnormal laboratory test results.
• Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders. Conditions that are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
• Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies).
• Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. Stable use (no initiation or change in dose ≤ 90 d of visit 1) of FDA-approved medications for hypertension is allowed.
• History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• Signs or symptoms of an active infection of clinical relevance ≤ 5 d of visit 1. The visit may be rescheduled once all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 d prior to visit 1.
• Recent use (≤ 6 mo of visit 1) of any prescription anti-hyperglycemic/weight loss medication. This includes, but is not limited to: metformin, insulin, DPP-4 inhibitors, SGLT-2 inhibitors, GLP-1 agonist, GIP agonists, Pioglitazone and Sulfonylureas.
• Use of any dietary supplement, other than conventional once-daily multivitamin/mineral supplements (within limits of the DRI) ≤ 14 d of visit 1 and throughout the study.
• Recent history (≤ 12 months visit 1) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
• Unstable use (change in dose) of any other prescription medications ≤ 90 d of visit 1, except for medications used PRN (e.g., asthma inhalers, non-drowsy seasonal allergy medications, etc.)
• Antibiotic use ≤ 90 d of visit 1 and throughout the study period.
• Regular use (≥ 3 days/week ≤ 30 d of visit 1) of anti-inflammatory medications (e.g., NSAIDs) and throughout the study period.
• Recent use of oral or injectable steroids, or topical or inhaled steroids (≥ 1500 µg/d) within 30 d of visit 1 and throughout the study period.
• Exposure to any non-registered drug product ≤ 30 d prior to visit 1.
• Diagnosed with major affective disorder, or other psychiatric disorder, that required hospitalization ≤ 12 months prior to visit 1.
• Recent (≤ 90 d of visit 1) endoscopy and/or colonoscopy procedure.
• Major trauma or any other surgical event ≤ 30 d of visit 1.
• Currently scheduled, or planning to schedule, an elective surgical procedure during the study.
• Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. Women who become pregnant during the study will be discontinued.

General safety related criteria

• Known sensitivity, intolerability, or allergy to any of the study products or study foods.
• Has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, and comply with the study protocol, which might confound the interpretation of the study results, or put the participant at undue risk.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Biofortis, Merieux NutriSciences — Addison

Публикации

• Moon JM, Ratliff KM, Hagele AM, Stecker RA, Mumford PW, Kerksick CM. Absorption Kinetics of Berberine and Dihydroberberine and Their Impact on Glycemia: A Randomized, Controlled, Crossover Pilot Trial. Nutrients. 2021 Dec 28;14(1):124. doi: 10.3390/nu14010124. PMID 35010998
• Yang J, Yin J, Gao H, Xu L, Wang Y, Xu L, Li M. Berberine improves insulin sensitivity by inhibiting fat store and adjusting adipokines profile in human preadipocytes and metabolic syndrome patients. Evid Based Complement Alternat Med. 2012;2012:363845. doi: 10.1155/2012/363845. Epub 2012 Mar 8. PMID 22474499
• Zhang H, Wei J, Xue R, Wu JD, Zhao W, Wang ZZ, Wang SK, Zhou ZX, Song DQ, Wang YM, Pan HN, Kong WJ, Jiang JD. Berberine lowers blood glucose in type 2 diabetes mellitus patients through increasing insulin receptor expression. Metabolism. 2010 Feb;59(2):285-92. doi: 10.1016/j.metabol.2009.07.029. Epub 2009 Oct 1. PMID 19800084
• Chan M, Qin Z, Man SC, Lam M, Lai WH, Ng RMK, Lee CK, Wong TL, Lee EHM, Wong HK, Feng Y, Liu L, Han F, Chen EYH, Zhang ZJ. Adjunctive berberine reduces antipsychotic-associated weight gain and metabolic syndrome in patients with schizophrenia: a randomized controlled trial. Psychiatry Clin Neurosci. 2022 Mar;76(3):77-85. doi: 10.1111/pcn.13323. Epub 2022 Jan 18. PMID 34931749

Идентификаторы

NCT: NCT07322679 · NNBHCS-BIO-2513

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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