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临床试验/NCT06546020
NCT06546020招募中不适用

PARTNERSHIP: Elucidating Gut Microbiota-dependent Health Impacts of Haskap Berries to Inform Agricultural Production Practices That Will Maximize Bioactive Potential

Montana State University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
16 subunit ribosomal ribonucleic acid (16S rRNA) gut microbial composition

研究概览

简要总结

Polyphenol-rich Haskap berries (Haskap) have untapped therapeutic potential to improve human health, and agricultural producers in northern U.S. states are poised to increase production if consumer demand increases. A critical knowledge gap is that little is known about the interactions between gut microbes and Haskap polyphenols to produce bioactive metabolites linked to downstream health impacts. Additionally, little is known about which Haskap varieties and harvest timing yield the greatest bioactive potential. This study aims to address these gaps by investigating the interaction of bioactive components in Haskap with gut microbiota and the resultant gut and serum metabolites, inflammation, and metabolic health, and then couple this with analysis of berries from different Haskap varieties and harvest times.

详细描述

The long-term goal of this project is to form a partnership linking the health impacts of Haskap varieties and management practices that maximize health-promoting compounds to benefit both consumers and producers. Specific objectives of this study are to determine 1) the impact of Haskap on the gut microbiome and metabolome, 2) how gut microbiome composition and production of bioactive metabolites from Haskap impacts health and inflammation biomarkers, and 3) which Haskap varieties and growing practices increase production of health-promoting compounds.

To accomplish this, a four-armed, randomized, triple-blind, placebo controlled clinical trial of Haskap versus placebo for two separate groups with distinctly low and high metabolic syndrome status will be completed. Participants will be assessed for health biometrics, fat oxidation, gut microbiome composition, inflammation, and both the gut and serum metabolome before and after 8 weeks of intervention. Haskap fruit from twenty varieties will primarily come from the randomized block design field trial and fruit will be harvested at four stages of fruit maturity, then analyzed for polyphenol content. This part of the study will be replicated over three growing seasons.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

Placebo and haskap interventions were designed to be comparable in taste and appearance.

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • BMI <18 or > 40 kg/m^2
  • potential allergy to Haskap or placebo ingredients
  • use of anti-inflammatory, lipid lowering, glucose lowering, blood pressure, or any other medications that may interfere with study measures
  • pregnant or lactating woman
  • diagnosis with type 1 or type 2 diabetes or any other condition that may interfere with study measures
  • smoke cigarettes
  • have taken antibiotics in the past 90 days
  • take supplements including pre/probiotics or "superfoods" within 30 days of starting the study
  • are planning on starting a weight loss or exercise regiment change
  • follow a specific diet such as low carbohydrate, vegan, and vegetarian
  • consume over 5 servings of fruit/vegetables per day
  • are unwilling to reduce caffeine intake to one 8 oz serving per day for the durations of the study

结局指标

主要结局

16 subunit ribosomal ribonucleic acid (16S rRNA) gut microbial composition

时间窗: 8 weeks

fecal microbial composition

Inflammation (pg/mL)

时间窗: 8 weeks

Serum interleukin (IL) IL-1B, IL-6, IL-10, IL-17, IL-23, tumor necrosis factor alpha (TNF-alpha), granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFN-gamma)

Lipid Panel (mg/dL)

时间窗: 8 weeks

Serum triglycerides (TG), low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, total cholesterol (CHOL), glucose (GLU)

F2 isoprostanes

时间窗: 8 weeks

urine

Exercise Induced Fat Oxidation

时间窗: 8 weeks

Measurement in g/min of fat being utilized during exercise at 40-60% of the participants estimated VO2max

Untargeted metabolomic analysis

时间窗: 8 weeks

Serum metabolome

次要结局

  • Acute Diet(8 weeks)
  • Habitual Diet(Baseline)
  • Blood pressure(8 weeks)
  • Estimated VO2 max(0 weeks)
  • Anthropometric Assessments(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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