Effect of Protein Source During Ketogenic Weight Loss Intervention on Lipid Metabolism and Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Substrate oxidation
研究概览
简要总结
This randomized, controlled, single-blinded study will investigate how the protein source in a high-protein ketogenic diet affects metabolic weight loss outcomes after a 12-week dietary intervention
详细描述
This randomized, controlled, single-blinded study will compare how a ketogenic weight loss diet, supplemented with either animal- or plant-based protein affects: (i) metabolic markers (adipokine and cytokine) in adipose tissue and blood, (ii) adipose tissue immune cell profiles, and (iii) adipocyte characteristics and their interaction with other cells (e.g. immune cells and muscle cells). To better determine how tissue characteristics affect the whole body level, the relationships between adipose tissue characteristics and blood lipid and inflammatory markers will also be examined. Participants undergo anthropometric measurements, questionnaires, body composition assessment, energy assessment, blood draws, and adipose tissue biopsies from the abdominal and femoral adipose tissue depots
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 (Participant)
盲法说明
Participants are provided with unlabelled protein containers in this single-blind study.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between 18-60 years old
- •BMI: >29.99kg/m2
排除标准
- •Any chronic metabolic conditions (e.g. CVD)
- •Renal impairment (creatinine clearance <60 mL/min)
- •Uncontrolled hypothyroidism
- •Pregnant, breastfeeding, or postmenopausal females
- •Past (<6 year) or present use of nicotine products
- •Use of cannabis products
- •Use of any other medications that may affect study outcomes (e.g. anti-depressants)
- •Participants who have had a number of CT scans in the course of the year
- •Participants following a vegan diet
结局指标
主要结局
Substrate oxidation
时间窗: Baseline and at 12 weeks
Substrate oxidation will be measured in a fasted state by indirect calorimetry. Volume of oxygen and carbon dioxide and water vapor pressure will be taken into consideration to calculate the respiratory exchange ratio.
Lipidomics
时间窗: Baseline and at 12 weeks
Lipidomics will be measured by mass spectrometry.
Adipocyte size
时间窗: Baseline and at 12 weeks
Regional adipocyte characteristics will be measured in vitro including adipocyte size,
Change in weight
时间窗: Baseline and at 12 weeks
Overall weight loss, kg
Change in overall body fat percentage
时间窗: Baseline and at 12 weeks
Body composition is measured by dual energy x-ray absorptiometry.
Regional subcutaneous adipose tissue immune cells ( number of cells per gram tissue, percentage of the stromal vascular compartment)
时间窗: Baseline and at 12 weeks
Changes in various adipose tissue immune cells including M1-like and M2-like macrophages, T helper cells, and cytotoxic T cells will be measured via flow cytometry.
Resting energy expenditure
时间窗: Baseline and at 12 weeks
Resting energy expenditure will be measured in a fasted state by indirect calorimetry. Volume of oxygen and carbon dioxide and water vapor pressure will be taken into consideration to calculate the resting energy expenditure.
Change in BMI
时间窗: Baseline and at 12 weeks
Height and weight will be combined to report BMI (kg/m\^2)
Change in fat mass
时间窗: Baseline and at 12 weeks
Body composition is measured by dual energy x-ray absorptiometry.
Concentrations of Circulatory cytokines and adipokines
时间窗: Baseline and at 12 weeks
Changes in cytokines and adipokines will be measured via ELISA. We will measure markers including interleukin 6, tumour necrosis factor a, leptin, and adiponectin.
Rate of pre-adipocyte proliferation
时间窗: Baseline and at 12 weeks
Regional adipose tissue pre-adipocyte proliferation rate will be measured in vitro
次要结局
未报告次要终点