An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women: a Placebo-controlled, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- general well-being (Short Form-12)
研究概览
简要总结
This study evaluates the impact of two Ambrotose products on immunity, gut health, and associated measures in healthy men and women. Subjects are randomly assigned in double-blind manner to one of five conditions: 1) 2 grams Advanced Ambrotose, 2) 4 grams Advanced Ambrotose, 3) 2 grams Ambrotose LIFE, 4) 4 grams Ambrotose LIFE, or 5) placebo. Subjects ingested their assigned condition daily for eight weeks.
详细描述
The product Ambrotose, which contains a blend of glyconutrients, has been used by human subjects for several years. It has been shown to enhance immunity, improve cognitive performance, and enhance antioxidant capacity. To date, the treatment with Ambrotose has been very well tolerated, with adverse events limited to "mild" or "self-limiting" or absent altogether.
This study evaluates the impact of two Ambrotose products on immunity, gut health, and associated measures in healthy men and women. Subjects are randomly assigned in double-blind manner to one of five conditions: 1) 2 grams Advanced Ambrotose, 2) 4 grams Ambrotose Advanced, 3) 2 grams Ambrotose LIFE, 4) 4 grams Ambrotose LIFE, or 5) placebo. Subjects ingested their assigned condition daily for eight weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •must be physically active by participating in structured exercise at least twice per week for 30 or more minutes per session;
- •not be pregnant
排除标准
- •diagnosed cardiovascular disease
- •diagnosed metabolic disease
- •diagnosed neurological disease
- •using nutritional supplements or medications known to impact immunity or gut health
研究组 & 干预措施
2 grams Ambrotose LIFE
2 grams daily for 8 weeks
干预措施: Ambrotose LIFE (Dietary Supplement)
4 grams Ambrotose LIFE
4 grams daily for 8 weeks
干预措施: Ambrotose LIFE (Dietary Supplement)
2 grams Advanced Ambrotose
2 grams daily for 8 weeks
干预措施: Advanced Ambrotose (Dietary Supplement)
4 grams Advanced Ambrotose
4 grams daily for 8 weeks
干预措施: Advanced Ambrotose (Dietary Supplement)
Placebo
4 grams Maltodextrin daily for 8 weeks
干预措施: Placebo (Other)
结局指标
主要结局
general well-being (Short Form-12)
时间窗: at 8 weeks
A 12-item questionnaire was used to measure functional health and well-being from the subject's point of view during their intervention. Scores range from 0 to 100, with higher scores representing better self-reported health
The Self-reported psychological general well-being index was used to assess subject's perceived well-being during their intervention. The index goes from 0 (worst possible level of well-being) to 110 (maximum level of well being)
时间窗: at 8 weeks
The Self-reported psychological general well-being index was used to assess subject's perceived well-being during their intervention. The index goes from 0 (worst possible level of well-being) to 110 (maximum level of well being)
Interleukin-10 (IL-10) level following blood incubation
时间窗: at 8 weeks
IL-10 was measured following blood incubation with Roswell Park Memorial Institute (RPMI) medium for 6 hrs
Interleukin-1beta (IL-1beta) level following blood incubation
时间窗: at 8 weeks
IL-1beta was measured following blood incubation with RPMI medium for 6 hrs
Self-reported psychological general well-being index
时间窗: at baseline
The Self-reported psychological general well-being index was used to assess subject's perceived well-being during their intervention. The index goes from 0 (worst possible level of well-being) to 110 (maximum level of well being)
Self-reported assessment of fatigue & associated variables
时间窗: at 8 weeks
A visual analog scale in which the subject was asked to make a mark on a 100-mm scale to indicate how he/she felt in regards to the variable in question during their intervention with 0 being "not at all" and 100 being "the most"
IL-6 level following blood incubation with LPS
时间窗: at 8 weeks
IL-6 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
White blood cell numbers
时间窗: at 8 weeks
We determined the white blood cell numbers for each subject during their intervention.
Interleukin-6 (IL-6) level following blood incubation
时间窗: at 8 weeks
IL-6 was measured following blood incubation with RPMI medium for 6 hrs
IL-1beta level following blood incubation with LPS
时间窗: at 8 weeks
IL-1beta was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
TNFalpha level following blood incubation with LPS
时间窗: at 8 weeks
TNFalpha was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
Serum Zonulin levels
时间窗: at 8 weeks
Zonulin from blood serum during the intervention was measured using an ELISA
Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation
时间窗: at 8 weeks
TNFalpha was measured following blood incubation with RPMI medium for 6 hrs
IL-10 level following blood incubation with lipopolysaccharide (LPS)
时间窗: at 8 weeks
IL-10 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
general well-being (Short Form-12)
时间窗: at baseline
A 12-item questionnaire was used to measure functional health and well-being from the subject's point of view during their intervention. Scores range from 0 to 100, with higher scores representing better self-reported health
general well-being (Short Form-12)
时间窗: at 4 weeks
A 12-item questionnaire was used to measure functional health and well-being from the subject's point of view during their intervention. Scores range from 0 to 100, with higher scores representing better self-reported health
The Self-reported psychological general well-being index was used to assess subject's perceived well-being during their intervention. The index goes from 0 (worst possible level of well-being) to 110 (maximum level of well being)
时间窗: at 4 weeks
The Self-reported psychological general well-being index was used to assess subject's perceived well-being during their intervention. The index goes from 0 (worst possible level of well-being) to 110 (maximum level of well being)
Self-reported assessment of fatigue & associated variables
时间窗: at baseline
A visual analog scale in which the subject was asked to make a mark on a 100-mm scale to indicate how he/she felt in regards to the variable in question during their intervention with 0 being "not at all" and 100 being "the most"
Self-reported assessment of fatigue & associated variables
时间窗: at 4 weeks
A visual analog scale in which the subject was asked to make a mark on a 100-mm scale to indicate how he/she felt in regards to the variable in question during their intervention with 0 being "not at all" and 100 being "the most"
White blood cell numbers
时间窗: at baseline
We determined the white blood cell numbers for each subject during their intervention.
White blood cell numbers
时间窗: at 4 weeks
We determined the white blood cell numbers for each subject during their intervention.
Interleukin-10 (IL-10) level following blood incubation
时间窗: at baseline
IL-10 was measured following blood incubation with Roswell Park Memorial Institute (RPMI) medium for 6 hrs
Interleukin-10 (IL-10) level following blood incubation
时间窗: at 4 weeks
IL-10 was measured following blood incubation with Roswell Park Memorial Institute (RPMI) medium for 6 hrs
Interleukin-6 (IL-6) level following blood incubation
时间窗: at baseline
IL-6 was measured following blood incubation with RPMI medium for 6 hrs
Interleukin-6 (IL-6) level following blood incubation
时间窗: at 4 weeks
IL-6 was measured following blood incubation with RPMI medium for 6 hrs
Interleukin-1beta (IL-1beta) level following blood incubation
时间窗: at baseline
IL-1beta was measured following blood incubation with RPMI medium for 6 hrs
Interleukin-1beta (IL-1beta) level following blood incubation
时间窗: at 4 weeks
IL-1beta was measured following blood incubation with RPMI medium for 6 hrs
Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation
时间窗: at baseline
TNFalpha was measured following blood incubation with RPMI medium for 6 hrs
Tumor Necrosis Factor alpha (TNFalpha) level following blood incubation
时间窗: at 4 weeks
TNFalpha was measured following blood incubation with RPMI medium for 6 hrs
IL-10 level following blood incubation with lipopolysaccharide (LPS)
时间窗: at baseline
IL-10 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
IL-10 level following blood incubation with lipopolysaccharide (LPS)
时间窗: at 4 weeks
IL-10 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
IL-6 level following blood incubation with LPS
时间窗: at baseline
IL-6 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
IL-6 level following blood incubation with LPS
时间窗: at 4 weeks
IL-6 was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
IL-1beta level following blood incubation with LPS
时间窗: at baseline
IL-1beta was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
IL-1beta level following blood incubation with LPS
时间窗: at 4 weeks
IL-1beta was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
TNFalpha level following blood incubation with LPS
时间窗: at baseline
TNFalpha was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
TNFalpha level following blood incubation with LPS
时间窗: at 4 weeks
TNFalpha was measured following blood incubation with RPMI medium containing lipopolysaccharide (final concentration 250 ng/mL) for 6 hrs
Serum Zonulin levels
时间窗: at baseline
Zonulin from blood serum during the intervention was measured using an ELISA
Serum Zonulin levels
时间窗: at 4 weeks
Zonulin from blood serum during the intervention was measured using an ELISA
次要结局
- Dietary Intake(at 8 weeks)
- Dietary Intake(at baseline)
- Dietary Intake(at 4 weeks)
研究者
Richard Bloomer
Dean
University of Memphis