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临床试验/NCT07299942
NCT07299942招募中不适用

Beta-glucan Supplementation During Calorie and Carbohydrate-restricted Diet: Impact on Body Weight and Body Fat Loss, Subjective Appetite, and Gastrointestinal Appetite Hormones of Healthy Women With Overweight.

University of Glasgow2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月1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
60
试验地点
2
主要终点
Body weight

研究概览

简要总结

This study will investigate whether beta-glucan supplementation, when added to an energy and carbohydrate-restricted diet, facilitates body weight and body fat loss, and leads to less detrimental changes in subjective appetite and gastrointestinal appetite hormones. This will be a double-blind, randomised, controlled trial in which healthy females living with overweight and obesity will be randomly assigned to a beta-glucan or a cellulose (placebo) group (1:1 basis). The randomisation software will be used to generate a randomisation list. This list will be held by a person independent of the research team. During the 4-week intervention, participants will consume an energy and carbohydrate-restricted diet combined with 9 g/day of beta-glucan (beta-glucan group) or 9 g/day of cellulose (Placebo group). During the 4-week intervention, breakfasts and dinners will consist of energy-restricted meal replacements providing 200 kcal/ meal, while lunches will be low-carbohydrate meals providing 35% of habitual energy intake. Before and at the end of the intervention, participants will conduct an experimental trial, with pre- and post-intervention trials being identical. The experimental trials will take place in the metabolic room of the New Lister Building (NLB) of the Glasgow Royal Infirmary. During the experimental trials, body weight and body composition will be measured in the fasted state, and the collection of fasting and postprandial (for the duration of 240 minutes) blood samples will be conducted. For a meal, participants will consume the low-calorie breakfast, which will be a liquid meal replacement (Cambridge Weight Plan, Corby, UK), together with 3 g of beta-glucan. Subjective appetite scores will be measured in the fasted and postprandial states. To achieve total body water and thus body composition (fat mass and fat-free mass) measurements, saliva will be collected before and 3 and 3.5 hours after consumption of D2O (which will be consumed in the fasted state). For the duration of 24 hours before the experimental trial, participants will be asked to avoid coffee and alcohol. Participants will be required to record their food and drink intake for three days before the trial days of each experimental investigation.

详细描述

This study will investigate whether beta-glucan supplementation, when added to an energy and carbohydrate-restricted diet, facilitates body weight and body fat loss, and leads to less detrimental changes in subjective appetite and gastrointestinal appetite hormones. This will be a double-blind, randomised, controlled trial in which healthy females living with overweight and obesity will be randomly assigned to a beta-glucan or a cellulose (placebo) group (1:1 basis).

Participants Based on power calculations and taking into consideration a drop-out rate of approximately 25%, this study will aim to recruit 60 sedentary females living with overweight or obesity (30 in each group), aged between 18 and 60 years and with a body mass index (BMI) between 25 and 39.9 kg/m².

Study design To confirm the eligibility, study participants will undergo a screening session. The screening visit will involve completion of a health questionnaire, height and body weight, and resting metabolic rate measurements. Eligible participants will be randomised either to the beta-glucan or the placebo group. Randomisation will be performed using Excel software. To ensure that the study was blinded, an independent person labelled the packs of fibre as either 'A' or 'B', indicating the β-glucan or placebo group.

Prior to the 4-week intervention, participants will undergo an experimental trial. This trial will be conducted at the Metabolic Investigation Laboratory, beginning at approximately 9:00 am, following an overnight fast. Height and body weight will be measured using the same procedures employed during the screening session. Participants will then complete a subjective appetite questionnaire. After that, a cannula will be placed into the antecubital vein. After a 10-minute rest period, a fasting blood sample will be collected. Following this, a baseline saliva sample will be obtained, and participants will be asked to consume deuterium oxide (D₂O) mixed with regular drinking water. Immediately after the baseline saliva collection, participants will consumed a standardised low-calorie breakfast (~200 kcal; carbohydrates: 20-25 g, protein: 15-20 g, fat: ~3 g, fibre: ~2 g) which will be a liquid meal replacement (Cambridge Weight Plan, Corby, UK), mixed with either 3 g of β-glucan or 3 g of cellulose as a placebo. During the experimental trials, blood samples and subjective appetite scores will be collected at 30-minute intervals for the duration of 240 minutes, and additional saliva samples will be collected at 3 hours and 3.5 hours post-ingestion of deuterium oxide water. The identical trial will be conducted after the intervention completion.

During the 4-week intervention, participants will consume an energy and carbohydrate-restricted diet combined with 9 g/day of beta-glucan (beta-glucan group) or 9 g/day of cellulose (Placebo group). During the 4-week intervention, breakfasts and dinners will consist of energy-restricted meal replacements providing 200 kcal/ meal, while lunches will be low-carbohydrate meals providing 35% of habitual energy intake.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy females living with overweight or obese (BMI of 25 - 39.9 kg/m2).
  • Age between 18 to 60 years.
  • Stable body weight for at least 3 months preceding the study.

排除标准

  • Irregular menstrual cycle
  • Exercising more than 75min a week
  • Pregnant or lactating
  • Food allergies
  • Vegan or vegetarian or follow any diet other than the typical Western diet.
  • Taking dietary supplement at the time of the study.

结局指标

主要结局

Body weight

时间窗: At the beginning (baseline, week 0 ) and at the end of the 4-week intervention, (post, week 4).

Body weight will be assessed in the fasted state using bioelectrical impedance analysis (TANITA-TBF-310, Cranela, UK).

Total body water

时间窗: At the beginning (baseline, week 0 ) and at the end of the 4-week intervention (post, week 4).

Saliva samples collected before and after 3 hours and 3.30 hours of drinking D2O water during experimental trials, which will be conducted before and after 4 week intervention, will be analysed for total body water using Fourier Transform spectroscopy (FTIR).

Subjective appetite

时间窗: At the beginning (baseline, week 0 ) and at the end of the 4-week intervention (post, week 4).

Assessment of fasting and postprandial (over a duration of 240 minutes) appetite via visual analogue scale (100mm) during the experimental trials, conducted before (week 0) and after 4 4-week intervention.

Body weight

时间窗: At the beginning (baseline, week 0 ) and at the end of the 4-week intervention, (post, week 4).

Body weight will be assessed in the fasted state using bioelectrical impedance analysis (TANITA-TBF-310, Cranela, UK).

Total body water

时间窗: At the beginning (baseline, week 0 ) and at the end of the 4-week intervention (post, week 4).

Saliva samples collected before and after 3 hours and 3.30 hours of drinking D2O water during experimental trials, which will be conducted before and after 4 week intervention, will be analysed for total body water using Fourier Transform spectroscopy (FTIR).

Subjective appetite

时间窗: At the beginning (baseline, week 0 ) and at the end of the 4-week intervention (post, week 4).

Assessment of fasting and postprandial (over a duration of 240 minutes) appetite via visual analogue scale (100mm) during the experimental trials, conducted before (week 0) and after 4 4-week intervention.

次要结局

  • Gastrointestinal appetite hormones(At the beginning (baseline, week 0 ) and at the end of the 4-week intervention (post, week 4).)
  • Gastrointestinal appetite hormones(At the beginning (baseline, week 0 ) and at the end of the 4-week intervention (post, week 4).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Dalia Malkova

Dr

University of Glasgow

研究点 (2)

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