Trial Outcomes & Findings for The Effects of Alcohol Consumption on Central Adiposity (NCT NCT03521817)

NCT ID: NCT03521817

Last Updated: 2020-06-17

Results Overview

change in visceral abdominal adipose tissue from baseline to post intervention

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2020-06-17

Participant Flow

Participant milestones

Measure	Alcohol Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat; (minus the \~240 kcals from ethanol). The Etoh group will consume a 30% energy restriction diet that will also include \~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). Alcohol: The ethanol group will consume a 30% energy restriction diet that will also include \~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). In the United States, one "standard" drink contains roughly 14 grams of pure alcohol.	No Alcohol No Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat). No Alcohol: This group will not consume alcohol. Thus 0 kcal/d will come from alcohol
Overall Study STARTED	7	5
Overall Study COMPLETED	7	4
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Alcohol Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat; (minus the \~240 kcals from ethanol). The Etoh group will consume a 30% energy restriction diet that will also include \~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). Alcohol: The ethanol group will consume a 30% energy restriction diet that will also include \~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). In the United States, one "standard" drink contains roughly 14 grams of pure alcohol.	No Alcohol No Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat). No Alcohol: This group will not consume alcohol. Thus 0 kcal/d will come from alcohol
Overall Study Protocol Violation	0	1

Baseline Characteristics

The Effects of Alcohol Consumption on Central Adiposity

Baseline characteristics by cohort

Measure	Alcohol n=7 Participants Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat; (minus the \~240 kcals from ethanol). The Etoh group will consume a 30% energy restriction diet that will also include \~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). Alcohol: The ethanol group will consume a 30% energy restriction diet that will also include \~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). In the United States, one "standard" drink contains roughly 14 grams of pure alcohol.	No Alcohol n=5 Participants No Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat). No Alcohol: This group will not consume alcohol. Thus 0 kcal/d will come from alcohol	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32 years STANDARD_DEVIATION 9 • n=5 Participants	31 years STANDARD_DEVIATION 7 • n=7 Participants	32 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

change in visceral abdominal adipose tissue from baseline to post intervention

Outcome measures

Measure	Alcohol n=7 Participants Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat; (minus the \~240 kcals from ethanol). The Etoh group will consume a 30% energy restriction diet that will also include \~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). Alcohol: The ethanol group will consume a 30% energy restriction diet that will also include \~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). In the United States, one "standard" drink contains roughly 14 grams of pure alcohol.	No Alcohol n=3 Participants No Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat). No Alcohol: This group will not consume alcohol. Thus 0 kcal/d will come from alcohol
Change in Central (Abdominal) Adiposity	-0.250 kg Standard Error 0.115	-0.071 kg Standard Error 0.075

Adverse Events

Alcohol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

No Alcohol

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Alcohol n=7 participants at risk Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat; (minus the \~240 kcals from ethanol). The Etoh group will consume a 30% energy restriction diet that will also include \~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). Alcohol: The ethanol group will consume a 30% energy restriction diet that will also include \~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). In the United States, one "standard" drink contains roughly 14 grams of pure alcohol.	No Alcohol n=5 participants at risk No Etoh will have a 30% reduction in calories from weight maintenance and will consume the same percentage of each traditional macronutrient (20% protein, 50% carbohydrate, and 30% fat). No Alcohol: This group will not consume alcohol. Thus 0 kcal/d will come from alcohol
Respiratory, thoracic and mediastinal disorders Sinus Congestion	0.00% 0/7 • From baseline to completion of study 8 weeks later. Furthermore follow-up calls and emails (not in person visits) were performed post study. Thus total period of time adverse event data were collected was 12 weeks.	20.0% 1/5 • Number of events 1 • From baseline to completion of study 8 weeks later. Furthermore follow-up calls and emails (not in person visits) were performed post study. Thus total period of time adverse event data were collected was 12 weeks.
Skin and subcutaneous tissue disorders Pruritis (itching)	0.00% 0/7 • From baseline to completion of study 8 weeks later. Furthermore follow-up calls and emails (not in person visits) were performed post study. Thus total period of time adverse event data were collected was 12 weeks.	20.0% 1/5 • Number of events 1 • From baseline to completion of study 8 weeks later. Furthermore follow-up calls and emails (not in person visits) were performed post study. Thus total period of time adverse event data were collected was 12 weeks.
Respiratory, thoracic and mediastinal disorders Upper respiratory complaints (cold)	14.3% 1/7 • Number of events 1 • From baseline to completion of study 8 weeks later. Furthermore follow-up calls and emails (not in person visits) were performed post study. Thus total period of time adverse event data were collected was 12 weeks.	0.00% 0/5 • From baseline to completion of study 8 weeks later. Furthermore follow-up calls and emails (not in person visits) were performed post study. Thus total period of time adverse event data were collected was 12 weeks.

Additional Information

John W Apolzan

Pennington Biomedical Research Center

Phone: 225-763-2827

Email: john.apolzan@pbrc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place