NCT02350595已完成不适用
Fiskespisestudiene 2011-2014. Spiseforsøk Med Fisk. Delstudie 2: Studie av Mulige Effekter av Fet og Mager Fisk på Glukosemetabolismen og inflammasjonsmarkører i Overvektige Voksne.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Changes in serum concentrations of glucose
研究概览
简要总结
The potential health effects of high intake of lean or fatty fish will be investigated in overweight or obese adults. Participants consume 750g/week of fillets of fish for 8 weeks.
Hypothesis:
High intake of fatty or lean fish will beneficially affect glucose regulation and the immune system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥27 kg/m2
- •fasting blood glucose ≤7.0 mmol/L
排除标准
- •pregnancy
- •incompatibility with fish consumption (allergies, intolerance and/or dislike)
- •diagnosed diabetes mellitus, heart disease or gastrointestinal diseases
- •use of medications affecting lipid metabolism or glucose homeostasis
- •use of anti-inflammatory medications
- •use of supplements containing long chain n-3 fatty acids
- •intentional weight loss
- •and large fluctuation in body weight (>3 kg) over the previous two months
结局指标
主要结局
Changes in serum concentrations of glucose
时间窗: baseline and 8 weeks
次要结局
- Changes in serum vitamin concentrations after fish intake.(baseline and 8 weeks)
- Changes in markers of oxidative stress after fish intake.(baseline and 8 weeks)
- Changes in amino acids and metabolites of amino acids after a standardized meal.(baseline)
- Comparisons of amino acid concentrations in serum and urine between men and women(baseline)
- Changes in metabolites and co-factors involved in one-carbon metabolism after a standardized meal(baseline)
- Changes in insulin, insulin C-peptide, leukocyte fatty acids, leukocyte function, body weight and composition, and intake of energy and macronutrients within the groups over time.(baseline and 8 weeks)
- Changes in serum and urine concentrations of amino acids and metabolites of amino acids after fish intake.(baseline and 8 weeks)
- Changes in fecal microbiota profile after fish intake.(baseline and 8 weeks)
- Changes in fecal and serum concentrations of lipids and bile acids after fish intake.(baseline and 8 weeks)
- Quantification of markers of kidney dysfunction(baseline and 8 weeks)
- Changes in total neopterin after fish intake(baseline and 8 weeks)
- Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine between men and women(baseline)
研究者
Oddrun Anita Gudbrandsen
Researcher
University of Bergen
研究点 (2)
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