A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Gastrointestinal Tolerability, Prebiotic Effects, and Gut Health Benefits of FiberPrime®.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
研究概览
简要总结
Recent research shows that gut bacteria play an important role in metabolic conditions like obesity, diabetes, and IBS. Soluble and resistant fibres, including resistant dextrins, help improve gut health by supporting good bacteria and increasing short-chain fatty acids (SCFAs), which protect the gut and support metabolism. Tapioca-based resistant dextrin (TRD) is a gentle, fermentable fibre that reaches the colon, promotes probiotic growth, and produces beneficial SCFAs. Studies suggest that TRD can help lower post-meal blood sugar and insulin without causing major digestive discomfort. Although resistant fibres show promise for improving metabolism and gut balance, human studies are still limited, and gender differences are not well understood. This study will test two doses (25 g and 50 g) of tapioca-derived soluble fibre versus placebo for 30 days in healthy adults to evaluate its effects on digestion, stool pattern, gut microbiome, Short Chain Fatty Acids, and overall tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males and females aged 18-60 years both inclusive.
- •2.Participants with no history of specific diet or medication intake that could interfere with metabolic homeostasis and gut microbiota, including but not limited to oral or intravenous antibiotics, probiotics, or other microbiota-altering supplements within three months prior to recruitment.
- •3.Trial participants in normal health as determined by personal medical history and clinical examination including vital signs.
- •Participants willing and able to maintain a habitual,balanced diet throughout the study period and providing voluntary, written informed consent to participate in the study.
排除标准
- •1.Participants with a diagnosis of colonic inertia.
- •2.Participants with a history of surgical interventions within the last six months.
- •3.History of anorectal surgery.
- •4.Participants diagnosed with functional gastrointestinal disorders, including Functional Constipation, Irritable Bowel Syndrome , Inflammatory Bowel Disease , or chronic diarrhea.
- •5.Participants with structural abnormalities such as rectal prolapse, rectocele, or anorectal stricture.
- •6.Participants with untreated or uncontrolled systemic conditions and comorbidities.
- •7.A medical history of hypothyroidism, Grade 2 obesity, morbid obesity, or constipation associated with premenopausal or postmenopausal status.
- •8.Participants using antibiotics, probiotic products, herbal supplements, dietary fiber, or phytonutrient supplements.
- •Participants following an abnormal or restrictive dietary pattern example low sodium, fasting, ketogenic, or high-protein diets during the four weeks preceding enrollment or unwilling to maintain a normal, balanced diet during the study period.
- •Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study.
- •Participants with a history of substance abuse or heavy use of alcohol and drugs or tobacco use, where participants smoke more than 1 or 2 pack per day.
研究者
Dr Pankaj Nemade
Gunjkar Multispeciality Hospital