Investigating the Effect of the Combination of L-carnitine Tartrate, Dihydrocapsiate and Protein Yeast Hydrolysate (DNF10) for 12 Weeks on Energy Intake and Energy Expenditure in Overweight and Obese Adults: A Randomised Controlled Trial- (SPICE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in mean energy intake
研究概览
简要总结
This is a single-centre, double-blind, randomised, placebo-controlled, 2-arm, parallel-design trial.
This trial will examine the impact of a combined treatment of L-carnitine tartrate, dihydrocapsiate and protein yeast hydrolysate (otherwise known as the "study product") over 12 weeks on energy intake and expenditure in overweight and obese adults.
Approximately 44 participants will be recruited to this trial. Participants will give consent to investigator sites to collect their data. The participants will either be randomised to take the study product or placebo.
The main question that this trial aims to answer is:
The effect of the study product (L-carnitine tartrate, dihydrocapsiate and protein yeast hydrolysate) as compared to placebo on mean energy intake via 3 x 24h dietary recalls online at week 4.
详细描述
Obesity is a global public health issue that is linked with multiple diseases affecting the body such as the heart, lungs, digestion and metabolism. There are many factors to weight gain that can lead to overweight or obesity. One of them is when more calories (energy for the body from food and drink) are taken in than being used. Weight re-gain of 30-50% of the weight loss occurs within 1 year and 50% of the patients will return to their baseline weight 5 years after they started their weight loss regime. Weight re-gain after weight loss remains an unmet medical need.
This is a single-centre, double-blind, placebo-controlled, 2-arm, 12-week trial with randomisation to either the study product or placebo. The study product is blend of ingredients composed of L-carnitine tartrate, dihydrocapsiate and protein yeast hydrolysate (DNF-10®). Participants will consume a total of 4 capsules a day during 2 different intake occasions. The matching placebo is microcrystalline cellulose.
Ingredients within the study product have individually shown to increase energy expenditure, decrease energy intake, decrease body weight and/or fat mass and decrease appetite in humans, via different pathways. However, they have never been studied in combination. With the combination of these ingredients, Investigator hypothesises the increase of the size effect on negative energy balance via decreasing appetite/energy intake and increasing energy expenditure, targeting different pathways, to >100 kcal/day.
Study participants will provide written informed consent prior to any trial procedures taking place. Participants will attend clinic at the study site 4 times in total as well as complete a validated online questionnaire called Intake24 about foods they've eaten between the in-person study visits.
Main trial procedures include, blood sample collection, online 3x24h dietary recall completion, subjective appetite feelings via 100mm visual analogue scale (VAS) for hunger, fullness, satiety and desire to eat, ad libitum energy intake, energy expenditure (including fat oxidation) using indirect calorimetry, anthropometric measures and administration/compliance to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 21-65 years old (inclusive)
- •Male and Female
- •Body Mass Index (BMI) 28 - <35kg/m2 western criteria for western subjects or 25 - <32kg/m2 for south-Asian ethnicities
- •Comfortable using technology, such as a smartphone or laptop
- •Written informed consent
排除标准
- •On unstable medication in the last 6 months, that may impact trial outcomes (e.g., including antibiotics, steroids or medication affecting thyroid hormones, and gut hormones)
- •Weight change of ≥3 kg in the preceding 6 months
- •Eating behaviour disorders such as emotional, restrained or external eating determined via Dutch Eating Behaviour Questionnaire (DEBQ).
- •On a weight loss regime (defined by actively following a diet such as Atkins, weight watchers, meal replacements, low or very low carbohydrate diet, ketogenic diet, intermediate fasting or enrolled into a governmental health program)
- •Significant restrictions on food intake (i.e., regular breakfast skipping, regular cut on carbohydrates, regular intermitted fasting, increased alcohol consumption beyond units defined in exclusion criteria, diet reducing a specific macronutrient, diet significantly reducing calorie intake, excluding a group of food that was not excluded before).
- •Known food intolerances or allergy to any of the interventional supplemental products (L-carnitine, yeast, dihydrocapsiate (synthetic), peppers, cellulose).
- •Taking any drugs in the past 3 months that are GLP-1 receptor analogues, SGLT-2 inhibitors, any weight loss medications and any of the following drugs: cephaloridine, verapamil, valproic acid, and sulfonylureas, usually acting by competitive inhibition of L-carnitine transport by OCTN2 or drugs that affect outcome of interest, including showing a defect on fat absorption (e.g., Orlistat)
- •Known congenital dysfunction of specific organic cation carnitine transporter OCTN2
- •Pregnancy or lactation
- •Chronic metabolic disease (except high cholesterol)
- •History of significant organ dysfunction or disease that affect the primary and secondary outcomes of this trial.
- •Life expectancy less than 1 year
- •Known autoimmune disease or genetic disease (including Glucose-6-phosphate deficiency (G6PD) deficiency)
- •Gastrointestinal upset (such as diarrhoea/constipation in the last 2 weeks, abdominal cramping etc.) or disorders such as Chron's disease or inflammatory bowel syndrome or disorder
- •History and ongoing psychiatric illness that affect the primary and secondary outcomes of this trial.
- •Asthma or chronic lung disease requiring long term medications or oxygen.
- •Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV
- •Cancer, coronary heart disease
- •Subjects with history of hypo- and hyperthyroidism
- •Recent blood donation (<8 weeks)
- •Drink >14 units of alcohol per week on a regular basis
- •Consumption of recreational drugs
- •Current smokers (daily)
- •Medical history of difficulties in tolerating/undergoing study procedures planned in the present study, (e.g., like cannulation)
研究组 & 干预措施
Intervention Arm
干预措施: SPICE BLEND CAPSULE (Combination Product)
Placebo-control arm
干预措施: Placebo (Other)
结局指标
主要结局
Change in mean energy intake
时间窗: week 0 to week 4
Change in mean energy intake as measured via three consecutive 24-hour dietary recalls conducted online via Intake24, from week 0 to week 4.
次要结局
- 1. ENERGY EXPENDITURE(At Week 4 and 12)
- 2. ENERGY INTAKE AND APPETITE(At Week 4 and 12)
- 3. ANTHROPOMETRIC MEASURES(At Week 4 and 12)
- 4. SAFETY PROFILES(At Week 4 and 12)
- 5. METABOLIC BLOOD PROFILES(At Week 4 and 12)
- 4. SAFETY PROFILES(At Week 4 and 12)
- 3. ANTHROPOMETRIC MEASURES(At Week 4 and 12)
- 1. ENERGY EXPENDITURE(At Week 4 and 12)
- 2. ENERGY INTAKE AND APPETITE(At Week 4 and 12)
- 5. METABOLIC BLOOD PROFILES(Week 4 and 12)
- 2. ENERGY INTAKE AND APPETITE(At Week 12)